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Estudo clínico randomizado controlado para avaliação de retalhos rotacionados e retalhos avançados no tratamento de recessões gengivais

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ESTUDO CLÍNICO RANDOMIZADO CONTROLADO PARA AVALIAÇÃO DE RETALHOS ROTACIONADOS E RETALHOS AVANÇADOS NO TRATAMENTO

DE RECESSÕES GENGIVAIS

Niterói 2015

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ESTUDO CLÍNICO RANDOMIZADO CONTROLADO PARA AVALIAÇÃO DE RETALHOS ROTACIONADOS E RETALHOS AVANÇADOS NO TRATAMENTO

DE RECESSÕES GENGIVAIS

EDGARD DE MELLO FONSECA

Tese apresentada à Faculdade de Odontologia da Universidade Federal Fluminense, como parte dos requisitos para obtenção do título de Doutor, pelo Programa de Pós-Graduação em Odontologia.

Área de Concentração: Odontologia

Orientador:

Prof. Dr. Ronaldo Barcellos de Santana

Niterói 2015

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Prof(a). Dr(a). Guaracilei Maciel Vidigal Júnior

Instituição: Universidade do Estado do Rio de Janeiro

Decisão: _________________________Assinatura:_________________________ Prof(a). Dr(a). Luis Felipe Schneider

Instituição: Universidade Veiga de almeida

Decisão: _________________________Assinatura:_________________________

Prof(a). Dr(a). Monica Diuana Calasans Maia Instituição: Universidade Federal Fluminense

Decisão: _________________________Assinatura:_________________________

Prof(a). Dr(a). Miriam Zaccaro Scelza

Instituição: Universidade Federal Fluminense

Decisão: _________________________Assinatura:_________________________

Prof(a). Dr(a). Ronaldo Barcellos de Santana Instituição: Universidade Federal Fluminense

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Aos meus pais, Mauro e Lenita (in memoriam), pelo exemplo deixado.

À minha mulher Maíra e ao meu filho Luca, pela felicidade que me proporcionam todos os dias.

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Ao Prof. Dr. Ronaldo Barcellos de Santana, pelo incentivo, paciência e exemplo de dedicação e competência.

À equipe de Periodontia da Faculdade de Odontologia da Universidade Federal Fluminense, por todas as oportunidades proporcionadas desde a minha graduação.

À equipe de Prótese Parcial Fixa da Faculdade de Odontologia da Universidade Federal Fluminense, pela excelente convivência ao longo destes anos.

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FONSECA, EM. Estudo clínico randomizado controlado para avaliação de retalhos rotacionados e retalhos avançados no tratamento de recessões gengivais [tese]. Niterói: Universidade Federal Fluminense, Faculdade de Odontologia; 2015.

Diversas técnicas cirúrgicas têm sido descritas para o recobrimento da recessão gengival (REC), dentre as quais incluem-se o retalho posicionado lateralmente (RPL) e o retalho posicionado coronariamente (RPC), realizado em estágio único ou em dois estágios, associado ou não à execução prévia de um enxerto gengival livre (EGL). O objetivo deste trabalho foi comparar a eficácia das técnicas de retalho posicionado lateralmente (RPL) e retalho posicionado coronariamente (RPC), ambas em único estágio, no tratamento de recessões gengivais localizadas, 1 e 5 anos após a realização do procedimento cirúrgico. Entraram neste estudo 36 participantes de pesquisa de ambos os gêneros, portadores de recessões classe I de Miller, com boa saúde sistêmica, ausência de doença periodontal, com idade média de 34 (± 7) anos, que estiveram disponíveis no período de duração do estudo e que concordaram em assinar o formulário do termo de consentimento livre e esclarecido. A amostra foi dividida em 2 grupos aleatoriamente: participantes do grupo controle, que foram submetidos a tratamento por meio de retalhos posicionados coronariamente (RPC) e participantes do grupo teste, que foram tratados através de retalhos posicionados lateralmente (RPL). Parâmetros clínicos periodontais (largura da gengiva inserida (LGI), profundidade clínica de sondagem (PCS) e recessão gengival (REC)) foram aferidos 6 meses antes, um e cinco anos após a realização das cirurgias para recobrimento radicular na face vestibular. O índice de placa visível (IPV) e o sangramento à sondagem (SS) foram, também, avaliados dicotomicamente. As diferenças entre as medições clínicas iniciais e após um e cinco anos foram submetidas à análise de variância (ANOVA) e, como testes post hoc, foram realizados o teste Chi-quadrado para variáveis qualitativas ordinais e o teste de Wilcoxon para variáveis quantitativas contínuas, com nível de significância < 0,05. Após um e cinco anos de acompanhamento, ambos os desenhos de retalho foram efetivos no tratamento das recessões gengivais, resultando em melhoria na porcentagem de cobertura radicular (CR). O retalho posicionado lateralmente (RPL) resultou em ganho significativo de

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Palavras-chave: recessão gengival; retalho posicionado lateralmente; retalho posicionado coronariamente, ensaio clínico randomizad controlado.

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FONSECA, EM. Randomized controlled clinical trial to evaluation of single-stage advanced versus rotated flaps in the treatment of gingival recessions [thesis]. Niterói: Federal Fluminense University, School of Dentistry; 2015.

Several procedures have been reported for the surgical correction of gingival recession (GR), including the laterally positioned flap (LPF) and the coronally advanced flap (CAF), performed as single or two-stage procedures without or with, respectively, the preceding placement and healing of a free gingival graft (FGG). The objective of the present report was to compare the efficacy of single-stage LPF and CAF techniques in the treatment of localized maxillary GR defects, 1 and 5 years after surgical procedure . Thirty-six patients, 10 men and 26 women, with average age of 34 ± 7 years with Miller class I GR defects were randomly assigned to be treated by either a CAF (n=18) or LPF (n=18). Clinical parameters, including recession height (RECH), the width of keratinized tissue (WKT) and clinical probing depth (PD) were assessed at the mid-buccal site. Visual plaque score (VPS) and bleeding on probing (BOP) were also assessed dichotomously. Clinical recordings were performed at baseline and after 1 and 5 years. The differences between pre-surgical clinical recordings and after 1 and 5 years were submited to analysis of variance (ANOVA) and, as post hoc tests, were performed the Chi-squared test for qualitative ordinal variables and Wilcoxon test for quantitative continuous variables, with statistical significance set at <0.05. Both flap designs were effective in treating recession defects. The LPF resulted in significantly more gains in KTW than the CAF and greater stability after 5 years.

Keywords: gingival recession; laterally positioned flap; coronally advanced flap, randomized controlled clinical trial.

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1 - INTRODUÇÃO

O termo doença periodontal descreve um número de entidades clínicas distintas que acometem o periodonto, incluindo a gengiva, a inserção gengival, o ligamento periodontal, o cemento e osso alveolar de suporte. A maioria destas entidades clínicas são infecções crônicas de origem bacteriana, caracterizadas clinicamente por alterações de forma, coloração e posicionamento da gengiva, podendo evoluir e acometer estruturas mais profundas do periodonto, com a formação de bolsa periodontal, perda óssea e mobilidade dentária 60.

A terapêutica periodontal compreende um conjunto de modalidades, cujos objetivos visam eliminar e/ou controlar os fatores etiológicos; paralisar a progressão da doença; obter resultados terapêuticos compatíveis com os requisitos biológicos e funcionais e atender, se possível, os anseios do paciente relacionados à estética1.

Dentre as várias modalidades terapêuticas descritas, a terapia mucogengival é um termo genérico utilizado para descrever procedimentos não-cirúrgicos e não-cirúrgicos para a correção de defeitos na morfologia, na posição e/ou na quantidade de tecido mole e osso subjacente de suporte em dentes e implantes59.

Miller (1993) introduziu o termo cirurgia plástica periodontal, sendo este definido como “procedimentos cirúrgicos para prevenir ou corrigir defeitos de gengiva, mucosa alveolar ou osso causados por fatores anatômicos, de desenvolvimento, traumáticos ou induzidos por doença” 63.

As recessões gengivais constituem um defeito da gengiva e/ou mucosa alveolar com repercussão funcional, uma vez que, geralmente, estão relacionadas com a perda de inserção progressiva e subsequente desnudamento radicular, associado a estreitas faixas residuais de gengiva inserida64. Podem, também,

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representar um importante problema estético, quando localizadas em segmento anterior, devido à desarmonia gerada no contorno gengival e ao aumento da dimensão cervico-incisal do elemento acometido26,27.

A recessão gengival progressiva é causada pela perda de inserção32 e

pode manifestar-se, clinicamente, associada à ausência de gengiva queratinizada5.

A exposição das superfícies radiculares como decorrência da recessão do tecido gengival marginal pode, também, resultar em sensibilidade dentinária32. Desta forma,

a recessão gengival representa um problema clínico periodontal com repercussões estético-funcionais, cuja relevância torna sua prevenção e tratamento um desafio para a terapia periodontal.

Com intuito de facilitar a comunicação e estabelecer um prognóstico em função da forma dos defeitos, Miller descreveu uma classificação morfológica das recessões gengivais5:

Classe I – recessão do tecido marginal que não se estende até a junção mucogengival, não havendo perda óssea, nem de tecido mole interdentário. Classe II – recessão do tecido marginal que se estende até ou além da junção mucogengival e não há perda óssea, nem de tecido mole interdental. Classe III – recessão do tecido mole que se estende até ou além da junção mucogengival e a perda óssea ou de tecido mole interdental é apical em relação à junção cemento-esmalte, porém coronária à extensão apical da recessão do tecido marginal. Classe IV – recessão do tecido marginal que se estende além da junção mucogengival e a perda óssea interdental estende-se até um nível apical em relação à extensão da recessão do tecido marginal.

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O completo recobrimento radicular pode ser alcançado nos defeitos classe I e classe II. Apenas um recobrimento parcial pode ser esperado em defeitos classe III e nenhum recobrimento pode ser obtido em defeitos classe IV.

Inúmeras técnicas têm sido descritas para a correção cirúrgica da recessão gengival, dentre as quais, a técnica de retalhos pediculados demonstra a particularidade de manter as ligações vasculares com os tecidos adjacentes, o que diminui o risco de necrose do retalho sobre a superfície radicular avascular6.

Na técnica de retalhos pediculados, o retalho posicionado lateralmente (RPL) e o retalho posicionado coronariamente (RPC) têm demonstrado bons resultados no tratamento de recessões gengivais9,,11,12,17,15,51,53,54-57. Ambos os

procedimentos possibilitam a cobertura radicular, com a vantagem de proporcionar um tecido gengival mais harmônico ao da região adjacente, além de utilizar apenas um tempo cirúrgico1,8,58.

O presente estudo consistiu num ensaio clínico, randomizado, controlado, de braços paralelos, com objetivo geral de comparar a eficácia das técnicas de RPC e RPL no tratamento de recessões gengivais localizadas classe I de Miller, 1 e 5 anos após a realização do procedimento. Os objetivos específicos foram avaliar o grau de recobrimento radicular, mensurar a dimensão da faixa de gengiva inserida e comparar as alterações longitudinais nos parâmetros de recobrimento radicular obtidos após a utilização das respectivas técnicas.

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2 - METODOLOGIA

O estudo foi conduzido de acordo com a Declaração de Helsinki de 1975, revisada em 2000 e com as normas de boas práticas clínicas com seres humanos.

O protocolo experimental deste estudo, que inclui a seleção dos pacientes que constituíram a amostra, material utilizado, procedimentos clínicos e cirúrgicos, foi submetido ao Comitê de Ética em Pesquisa da Universidade Federal Fluminense que, através do parecer CEP CMM/HUAP n°168/08 (anexo A), deu parecer favorável a todos os procedimentos previstos no presente trabalho.

Os voluntários ao estudo foram selecionados dentre os pacientes encaminhados para tratamento periodontal na clínica de Periodontia da Faculdade de Odontologia da Universidade Federal Fluminense, que atendiam os critérios de inclusão e que assinaram o termo de consentimento livre e esclarecido.

Os seguintes critérios de inclusão foram utilizados: pacientes adultos sem contra-indicação para cirurgia periodontal, não utilizando medicamentos que interferem na saúde ou cicatrização dos tecidos periodontais; presença de recessões gengivais maxilares classe I de Miller, nos incisivos, caninos ou pré-molares; profundidade clínica de sondagem (PCS) < 3 mm, sem sangramento à sondagem; vitalidade pulpar e ausência de cáries ativas ou restaurações nas áreas a serem tratadas.

Pacientes com doença periodontal, fumantes e com doenças sistêmicas imunodepressoras (i.e., câncer, AIDS, diabetes ou fazendo uso de imunosupressores) não foram incluídos no estudo. Recessões classes II, III ou IV de Miller, presença de imagem radiolúcida apical, cáries ou restaurações nas áreas a serem tratadas e antecedentes de falta de cooperação no programa de manutenção, também, foram considerados critérios de exclusão.

Foram avaliados 36 participantes (10 homens e 26 mulheres), com idade média de 34 (± 7) anos. O tamanho da amostra foi determinado, indicando que com uma amostra de 16 indivíduos, o estudo deveria ter > 90% de força para detectar diferença de 1mm na recessão marginal, entre os grupos.

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Um formulário do termo de consentimento livre e esclarecido (anexo B) foi assinado por todos os participantes, após a completa explicação acerca da natureza, riscos e benefícios da investigação clínica e procedimentos associados.

Todos os participantes foram submetidos à terapia periodontal básica e incluídos em programa de manutenção iniciado, no mínimo, 6 meses antes do início do estudo. O tratamento compreendeu instrução de higiene oral, raspagem e alisamento radicular, quando necessários, polimento dentário para controle de placa e correção de trauma de oclusão ou outros hábitos nocivos. Todos os participantes foram instruídos e treinados para o uso de escovas macias e à supressão de hábitos relacionados à etiologia da recessão. Cada defeito foi submetido aleatoriamente a uma das duas modalidades de tratamento empregado: retalho posicionado coronariamente (RPC) (n=18) ou retalho posicionado lateralmente (RPL) (n=18).

Os parâmetros clínicos foram avaliados, seguindo os critérios descritos por Santana et al.58. A REC foi medida no centro da face vestibular do dente,

utilizando-se a junção cemento-esmalte (JCE) como ponto de referência.

Exames clínicos intra-orais realizados em ambos os grupos, incluiram os seguintes dados anotados na ficha,:

(a) inspeção da cavidade bucal

(b) avaliação das condições periodontais, pelas mensurações de:

- profundidade clínica de sondagem (PCS): distância entre a margem gengival e o fundo do sulco gengival

- recessão gengival (REC): distância entre a junção cemento-esmalte e a margem gengival

- largura de gengiva queratinizada (LGQ): distância entre a margem gengival e a linha mucogengival

Todas as medidas clínicas foram realizadas, utilizando-se uma sonda UNC #15 (PCPUNC 15 – Hu-Friedy, Chicago, USA), com um cursor de borracha, por um único investigador, treinado e calibrado, independente do tratamento fornecido, antes,1 e 5 anos após a cirurgia. Todas as medidas registradas foram ≥ 1,0 mm. O ponto máximo da convexidade do contorno da margem gengival – zênite gengival (ZG) – foi empregado como a referência para medidas da margem gengival (MG). O índice de placa visível (IPV) e sangramento à sondagem (SS) foram avaliados dicotomicamente no centro da face vestibular.

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Antes do procedimento cirúrgico, foi administrada, a cada paciente, uma dose de 500mg de dipirona sódica (Novalgina, Sanofi Aventis Farmacêutica – São Paulo, Brasil).

A antissepsia intra-oral foi realizada com solução de digluconato de clorexidina 0,12% (Perioxidin, Laboratório Gross - Rio de Janeiro, Brasil)

Os pacientes foram anestesiados por bloqueio regional com cloridrato de lidocaína 2%, contendo epinefrina 1:100.000 (Alphacaine 100, DFL - Rio de Janeiro, Brasil).

O RPC foi delimitado por duas incisões verticais, nos lados mesial e distal da recessão a ser tratada, localizadas de tal forma que as papilas interproximais não fossem incluídas no retalho. As papilas não foram biseladas. Incisões verticais biseladas foram realizadas na gengiva inserida, evitando posterior formação de relação “topo a topo” entre o retalho e os tecidos adjacentes e continuadas alguns milímetros apicalmente na mucosa alveolar. As incisões verticais foram unidas por uma incisão intrasulcular. Na área interproximal, a papila foi dividida no sentido mésio-distal, resultando numa superfície plana de tecido conjuntivo e, como consequência, numa melhor área de contato entre o tecido do retalho e a porção conservada da papila, após reposicionamento e sutura do retalho. Um retalho de espessura mista foi elevado, permitindo que os primeiros 3-4 mm do aspecto coronal do osso alveolar fosse exposto, enquanto o remanescente permanecesse coberto pelo periósteo e tecido conjuntivo gengival. Em seguida, executou-se alisamento radicular com instrumentos manuais, rotatórios e ultrassônicos. Uma broca de granulação fina (Perio-Set, Intensiv S.A., Grancia, Switzerland) foi utilizada para reduzir a convexidade da superfície radicular e remover irregularidades. Após instrumentação, as superfícies radiculares foram lavadas com solução salina, com o intuito de remover eventuais fragmentos remanescentes destacados do defeito e do campo cirúrgico. Uma incisão horizontal complementar foi realizada na base do retalho, dividindo sua espessura e, consequentemente, liberando-o do periósteo aderido. Isso permitiu a liberdade em sentido coronal do retalho. Assim, o retalho foi posicionado coronariamente e estabilizado através de suturas individuais com fio monofilamentado de nylon 5.0 (Ethilon, Ethicon, NJ, USA).

Os procedimentos cirúrgicos para RPL foram realizados de acordo com técnicas padronizadas por SANTANA et al 1,58. O sítio receptor foi preparado,

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England). Incisões foram feitas nos lados mesial e distal da recessão, para remover a adesão epitelial e obter superfície de tecido conjuntivo. Estas incisões se estenderam vários milímetros, apicalmente, em direção à mucosa alveolar, com o objetivo de se obter um bisel externo no sítio receptor do dente a ser tratado, e um bisel interno no sítio adjacente ao retalho. Isso, proporcionou que quando o retalho fosse rotacionado e suturado no sítio receptor, uma relação “topo a topo” não fosse estabelecida e se obtivesse uma superfície ampla de contato entre o tecido conjuntivo do retalho e do sítio receptor. O tecido gengival excisado foi removido, e a superfície radicular foi, então, instrumentada como descrito anteriormente. O desenho do retalho foi definido por duas incisões verticais que se estendem, da incisão horizontal, vários milímentros apicalmente à junção mucogengival. A incisão horizontal foi realizada imediatamente na margem gengival ou 1 – 2 mm apicalmente, seguindo o contorno da margem gengival, unindo-se à incisão vertical. Quando o sítio doador era edêntulo, uma incisão horizontal linear biselada foi realizada para melhorar a quantidade de tecido queratinizado no retalho. A porção do retalho gengivo-mucoso relativo à área do dente mais próximo ao defeito foi de espessura total, e à do dente mais afastado, de espessura parcial. Dissecção em espessura parcial foi continuada apical e lateralmente, em ordem, para obter liberdade de movimento do retalho e ausência de inserções musculares ou adesão periosteal. O retalho foi rotacionado lateralmente para cobrir completamente o defeito de recessão e estender-se por, aproximadamente, 1 mm, coronal à JCE. Quando o retalho foi deslocado, conduziu o periósteo para a área receptora, e ao mesmo tempo, a porção de espessura parcial, revestiu a área doadora desnuda, correspondente à região do dente mais próximo. A coaptação das bordas foi realizada através de fios monofilamentados de nylon agulhados, 5.0. Cuidados na sutura do retalho foram adotados para posicionar e proteger os tecidos moles superiores à superfície radicular, por meio de suturas simples e suspensória.

Os pacientes foram medicados com analgésico sistêmico, com princípio ativo de paracetamol 750mg ( Tylenol 750, Jansen-Cilag Farmaceutica, São Paulo, Brazil ), a cada seis horas, por quatro dias. Um cimento cirúrgico (CoePak, GC America, USA) foi aplicado na ferida, imediatamente após a cirurgia, trocado após sete dias e removido após quatorze dias, em ambos os grupos. Os pacientes foram instruídos a continuar os cuidados de higiene oral regular em casa, exceto na área operada, onde a escovação dentária foi descontinuada nos primeiros

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30 dias após a cirurgia. O controle de placa foi mantido por meio de aplicação tópica suave de gel de digluconato de clorexidina (2%) (Perioxidin Gel, Laboratório Gross -Rio de Janeiro, Brasil) embebido em bastonete de algodão, duas vezes ao dia, durante 14 dias. Uma suave escovação com uma escova extra-macia (TePe Special Care - TePe, Malmö, Sweden) foi, então, iniciada. As suturas foram removidas duas semanas após a cirurgia.

Após a cirurgia, todos os participantes foram examinados, semanalmente, durante os primeiros três meses e, de 14 em 14 dias, nos três meses subsequentes. Então, os participantes foram examinados mensalmente até doze meses Após doze meses de acompanhamento, os exames foram realizados anualmente. As consultas de manutenção consistiram em reforço de procedimentos de higiene oral e polimento coronário supra-gengival profissional. O controle químico de placa adicional foi realizado uma vez a cada três meses, por meio de bochechos com uma solução de digluconato de clorexidina 0,12% (Perioxidin Gel, Laboratório Gross – Rio de Janeiro, Brasil), duas vezes ao dia, durante uma semana.

A estatística descritiva foi expressa por meio de médias de desvio-padrão (DP). A análise de variância (ANOVA) foi utilizada para comparar os resultados pré-cirúrgicos, de 1 e de 5 anos de acompanhamento. Então, as comparações inter-grupo e intra-grupo entre medidas iniciais e medidas de um e cinco anos foram analisadas por teste Wilcoxon (variáveis quantitativas contínuas) ou teste Chi-quadrado (variáveis qualitativas ordinais). O valor alfa menor que 0,05 foi utilizado para declarar significância estatística.

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3 - ARTIGO PRODUZIDO

Randomized clinical trial to comparative evaluation of single-stage advanced versus rotated flaps in the treatment of gingival recessions

Ronaldo B SANTANA, DDS, MScD, DSc*

Edgard de Mello FONSECA, DDS, MScD*

Maira B FURTADO, DDS, MScD*

Carolina M.L. MATTOS, DDS, MScD*

Serge DIBART, DDS, MScD**

* Graduate Program in Dentistry, Department of Periodontology, Federal Fluminense University, Dental School, Niteroi, Rio de Janeiro, Brazil.

** Department of Periodontology, Boston University, School of Dental Medicine, Boston, MA, USA.

Corresponding Address:

Ronaldo B Santana, DDS, MScD, DSc. Department of Periodontology

Dental School – Universidade Federal Fluminense

Rua Sao Paulo 28 – Niteroi – Rio de Janeiro 24040 115 – Brazil

E-mail: rbarsantana@ig.com.br

3160 words 2 tables 2 figures

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Short Title:

Randomized Controlled Clinical trials for evaluation of laterally positioned versus coronally advanced flap in recession defects.

Summary:

The laterally-positioned flap and the coronally advanced flap are effective for the treatment of Miller class I maxillary recession defects in humans with the laterally-positioned flap resulting in more gain in keratinized tissue and greater stability after 5 years of follow-up.

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ABSTRACT

BACKGROUND: The laterally positioned flap (LPF) and the coronally advanced flap (CAF), performed as single or two-stage procedures without or with, respectively, the preceding placement and healing of a free gingival graft (FGG) has been shown to be effective in treating maxillary single gingival recession (GR) defects. The objective of the present study was to compare the efficacy of single-stage LPF and CAF techniques in the treatment of localized maxillary GR defects, 1 and 5-years after surgical procedures.

METHODS: Thirty-six patients, 10 men and 26 women, with average age of 34 ± 7 years with Miller class I GR defects were randomly assigned to be treated by either a CAF (n=18) or LPF (n=18). Clinical parameters, including recession height (RECH), the width of keratinized tissue (WKT) and probing depth (PD) were assessed at the mid-buccal site. Visual plaque score (VPS) and bleeding on probing (BOP) were also assessed dichotomously. Clinical recordings were performed at baseline, 1 and 5 years later. The differences between initial clinical recordings and after 1 and 5 years were subjected to analysis of variance (ANOVA) and, as post hoc tests, were performed the Chi-squared test for qualitative ordinal variables and Wilcoxon test for quantitative continuous variables, with significance set at α<0.05.

RESULTS : Both flap designs were effective in treating recession defects. The LPF resulted in significantly more gains in KTW than the CAF and greater stability after 5 years.

CONCLUSION: The results obtained by LPF in the treatment of Miller class I demonstrated significantly more gains in KTW than the CAF and greater stability after 5 years.

KEY WORDS: gingiva, periodontal plastic surgery, surgical flaps, gingival recession; laterally positioned flap; coronally advanced flap, randomized clinical trial.

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INTRODUCTION

The term periodontal disease describes a number of distinct clinical entities that affect the periodontium including the gingiva, gingival attachment, periodontal ligament, cementum, and supporting alveolar bone. The most common periodontal diseases are chronic bacterial infections, characterized clinically by gingival changes in color, form, position, and surface appearance, and may extends into deeper structures of the periodontium with pocket formation, bone loss, and mobility60.

Periodontal therapy embrace a group of modalities whose objectives are intended the elimination and/or control of the etiologic factors; the arrest of disease progression; the obtainance of therapeutic results compatible with biological and functional requisites, and to satisfy, if possible, to the patient’s demands for aesthetics, health and functional confort1.

Among the various therapeutic modalities described, the mucogingival therapy is a generic term that describes surgical and nonsurgical procedures used to correct morphology defects, position defects and/or the amount of soft tissue and alveolar bone59.

Miller (1993) introduced the term plastic periodontal surgery, defined as “surgical procedures to prevent or correct gingival, alveolar mucosa or bone defects caused by anatomic factors, development factors, traumatic factors or disease induction factors of the teeth and implants63.

Gingival recession is considered a gingival and/or alveolar mucosa defect with functional repercussion since they are generally associated with progressive attachment loss and consequently root denudation, and narrow strip of attached gingiva64. They may also represent a major esthetic problem when localized in

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anterior dentition, due to disharmony caused in physiologic gingival countour2,3 and

the increase in cervico-incisal dimension of the affected tooth 26,27.

The progressive gingival recession is caused by loss of attachment4 and may

clinically occur associated with absence of keratinized gingiva5. Exposure of the root

surfaces due to recession of the marginal gingival tissues may also result in tooth sensitivity4. Therefore, GR is a significant periodontal clinical problem with potential

aesthetic and functional repercussions and its prevention and treatment are a major challenge in periodontal therapy.

To facilitate communication, Miller described a morphology classification of the gingival recessions5:

Class I - marginal tissue recession which not extends to mucogingival junction, without bone and interdental soft tissue loss. Class II - marginal tissue recession which extends to or beyond mucogingival junction, without bone and interdental soft tissue loss. Class III - marginal tissue recession which extends to or beyond mucogingival junction, and the interdental bone loss extends apically the cement-enamel junction, however with coronal position concerning the apical extension of the soft tissue recession. Class IV - marginal tissue recession which extends beyond mucogingival junction, and the interdental bone loss extends apically the soft tissue resection extension. The complete root coverage can be achieved in Class I and II defects. Only a partial coverage can be expected in Class III defects and none coverage can be obtained in Class IV defects.

Several procedures have been reported for the surgical correction of GR, and the pedicle flaps were considered to be an adequate choice due to the maintenance of vascular connections with the adjacent soft tissues, thus increasing the chances of survival of the flap on the avascular root surface6,7. Among the pedicle flaps, the

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laterally positioned flap (LPF) and the coronally advanced flap (CAF) present the possibility to cover the recession with gingival tissues more harmonic with the adjacent teeth by the use of a single surgical procedure1,8.

To the best of our knowledge, only one study has previously evaluated single-stage LPF and CAF procedures for the treatment of Miller class I and II GR defects58.

In this way, the objective of the present report was to evaluate the results after 1 and 5-years, comparing the efficacy of single-stage LPF and CAF techniques in the treatment of localized maxillary GR defects.

MATERIALS AND METHODS Study Population and Experimental Design

The study was designed as a randomized, controlled, parallel-arm, clinical trial. It was conducted in accordance with the guidelines of the Helsinki Declaration of 1975, as revised in 2000, and after approved by institutional review board approval. Form informed consent was obtained from all subject volunteers after thorough explanation of the nature, risks, and benefits of the clinical investigation and associated procedures. The study population consisted of patients referred for periodontal treatment at the School of Dentistry, Fluminense Federal University, Brazil. The following inclusion criteria were used: adult patients with no contraindications for periodontal surgery, and who had not taken medications known to interfere with periodontal tissue health or healing in the preceding 6 months, exhibiting the presence of Miller class I gingival recessions5 in maxillary incisors,

canines or premolars, probing depth (PD) <3mm without bleeding on probing, presenting tooth vitality and absence of caries or restorations in the areas to be treated. Patients with untreated periodontal disease, smokers, subjects with

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immunosuppressive systemic diseases (i.e., cancer, AIDS, diabetes) were not included in the study. Miller class II, III or class IV recession defects5, presence of

apical radiolucency or caries or restorations in the areas to be treated, and previous lack of cooperation with the maintenance program were also exclusion criteria. Thirty-six patients (10 men and 26 women), with average age of 34 ± 7 years, were included in the present prospective study. Sample size was determined by Power analysis, assuming  of .05, two-tailed z value of 1.96 and a standard deviation of 0.72. This calculation indicated that with a sample of 16 subjects, the study would have >90% power to detect a 1-mm difference in recession depth between the two groups.

All patients were subjected to initial periodontal therapy and were adherent to maintenance care for at least six months before the beginning of the study. Treatment included oral hygiene instructions, scaling and root planning where needed, tooth polishing plaque control measures and correction of traumatic tooth brushing technique or other negative habits. All patients were instructed and trained to use a soft toothbrush and to eliminate habits related to the etiology of the recession. Baseline full mouth plaque and bleeding scores were low. Each defect (one defect per patient) was randomly assigned to one of the two treatment modalities employed: coronally advanced flap (CAF)(n=18) or laterally-positioned flap (LPF) (n=18) by the toss of a coin.

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Clinical data collection

Clinical parameters were assessed as previously described3,58 at the

mid-buccal site from the teeth using the cemento-enamel junction (CEJ) or, when applicable, another defined landmark, as a fixed reference point from which REC was recorded. All measurements were recorded using an UNC #15 periodontal probe (PCPUNC 15 – Hu-Friedy, Chicago, USA) with a rubber stopper by a blinded, trained and calibrated examiner, unaware of the treatment provided, at baseline, 1 and 5 years after surgery. Measurements were recorded to nearest higher mm. The point of maximum convexity of the marginal gingival contour – the gingival zenith (GZ) – was employed as the reference for measurements of the gingival margin (GM). Visual plaque score (VPS) and bleeding on probing (BOP) were assessed dichotomously at the mid-buccal location. Recession height (RECH) was measured as the distance from the CEJ to GM. The width of keratinized tissue (WKT) was measured as the distance between the GM and the MGJ. PD was measured as the distance from the GM to the bottom of the gingival sulcus.

Surgical Procedures

Before surgery, each patient was given a single dose of 500 mg sodic dipyrone as an analgesic (Novalgina, Sanofi Aventis Farmacêutica – São Paulo, Brasil). Intraoral antisepsis was performed with a 0.12% chlorhexidine rinse (Perioxidin, Laboratório Gross - Rio de Janeiro, Brasil). Anesthesia was obtained by regional blocks with 2.0% Lidocaine with 1:100.000 epinephrine (Alphacaine 100, DFL - Rio de Janeiro, Brasil).

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Coronally Advanced Flap (CAF)

The CAF was designed performing two vertical releasing incisions at both the mesial and distal aspects of the recession to be treated, in such a way that both the proximal papillae were not included as part of the flap. Papillae were never bisected. Beveled vertical incisions were performed in the attached gingiva, avoiding the formation of butt-joints between the flap and adjacent tissues, and were continued several millimeters apically into the alveolar mucosa. The vertical incisions were joined by an intrasulcular incision. In the interproximal area, the papillae were split in a mesio-distal dimension, resulting in a flat surface of connective tissue for contact between the flap tissues and the retained portion of the papillae after repositioning and suturing of the flap. A combined mucoperiosteal-mucosal flap was elevated such that the first 3-4mm coronal aspect of the alveolar bone was exposed, while the remaining buccal bone was still covered by the periosteum and gingival connective tissue. Thorough root planning was performed with hand, rotary and ultrasonic instruments. A fine-grain finishing bur (*) was always used to reduce the convexity of the root surfaces and to remove sharp edges and grooves. After instrumentation, the root surfaces were washed with saline solution to attempt to remove any remaining detached fragments from the defect and surgical field. A complementary horizontal incision was performed on the apical aspect of the flap, releasing it from the attached periosteum. This allowed the elongation and free coronal positioning of the flap. The flap was coronally positioned and maintained in place by means of individual 5.0 monofilament sutures.

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Laterally Positioned Flap

The surgical procedures for the LPF were performed according standard techniques1,58. The receptor site was prepared using a surgical blade.

Incisions were made in both - mesial and distal - aspects of the recession, in order to remove the epithelial attachment and obtain connective tissue surfaces, which extended several millimeters apically toward the alveolar mucosa. These incisions were carried out to obtain an external bevel on the recipient site of the tooth to be treated, and an internal bevel on the adjacent aspect of the flap in such a way that when the flap was rotated and sutured in the receptor site a butt-joint relationship was not established, and a large surface of contact between the connective tissues of the flap and receptor site is established. The excised gingival tissues were removed, and the root surface was then instrumented as described above. The flap design was outlined by two vertical incisions which extended from the horizontal incision to several millimeters apically to the mucogingival junction. A horizontal incision was performed either at the gingival, or 1 - 2mm apically, following the marginal gingival contour, thus joining the vertical incisions. When the donor site was an edentulous site (n=4), a beveled linear horizontal incision was performed to optimize the content of keratinized tissue in the flap. The flap was elevated as full-thickness in the portion adjacent to the recession and as partial full-thickness in the portion distal to the recession. Partial-thickness dissection was continued apically and laterally in order to obtain passivity of flap movement and absence of muscle pull or periosteal adhesion. The flap was rotated laterally in order to completely cover the recession defect and extend for approximately 1mm coronal to the CEJ. Careful flap suturing was performed in order to position and secure the soft tissues over the root surface by means of sling and simple sutures.

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Post-Surgical Care

The patients were put on systemic analgesics consisting of 750 mg of paracetamol (**) every six hours for four days. A surgical dressing (***) was changed after seven days and removed after fourteen days for both groups. The patients were instructed to continue their regular home hygiene care, except in the operated area, in which tooth-brushing was discontinued for the first 30 days after surgery and plaque control was maintained by means of gentle topical applications of chlorhexidine gluconate (2.0%) in saturated cotton swabs twice a day. Gentle tooth-brushing with an extra soft-bristle toothbrush was then initiated. The sutures were removed two weeks after the surgery.

Maintenance Schedule

Following surgery, all patients were seen weekly during the first three months and bi-weekly for the next three months. Maintenance visits consisted of reinforcement of oral hygiene procedures and professional supra-gingival coronal polishing. Additional oral chemical plaque control was performed once every three months by means of mouth rinses with a solution of chlorhexidine gluconate 0.12% BID, for one week.

Statistical Analysis

All descriptive statistics were expressed as mean +/– standard deviation (SD). The differences between initial clinical recordings and after 1 and 5 years were subjected to analysis of variance (ANOVA) and, as post hoc tests, were performed the Chi-squared test for qualitative ordinal variables and Wilcoxon test for quantitative continuous variables, with significance set at α<0.05.

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RESULTS

Thirty-six patients (10 men and 26 women), with average age of 34 ± 7 years, with Miller’s class I GR in single-rooted teeth of the maxillary jaw were included in the present prospective study. The LPF group (n= 18) had an average age of 33 ± 8 years and the CAF group (n=18) had an average age of 35 ± 6 years. The GR defect distribution between the LPF and CAF groups, was, respectively: lateral incisor (3 and 4 teeth), canines (9 and 10 teeth), first molar (5 and 3 tooth), second pre-molar (1 tooth each group). Two patients dropped out of the study after 1 year. Full-mouth BOP and VPS were maintained below 20% indicating a good standard of supra-gingival plaque control during the study period (table 1).

Baseline, 1 year and 5 years measurements for the CAF and LPF groups are shown in Table 1. No statistically significant differences were observed between groups in any of the clinical parameters at baseline. Intra-group comparisons between baseline and 1 year and between baseline and 5 years measurements revealed that statistically significant changes from baseline were found for RECH for both the CAF and LPF groups. Neither group exhibited significant changes for PD, BOP and VPS. The LPF demonstrated statistically significant increases of WKT.

The magnitude of changes in measurements after 1-year and 5-years for the CAF and LPF groups are shown in Table 2. Inter-group comparisons demonstrated statistically significant RECH reduction changes for both procedures. Changes in WKT favored the LPF procedure (2.3 versus 0 – after 1 year; 2 versus 0 – after 5 years). Differences in measurements for PD, SBI and VPI did not reveal significant differences between the groups. Complete root coverage was accomplished in 88.88% (15 out of 18) of the treated cases in the CAF group after 1

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year and 56,25% (9 out 16) after 5 years. In the LPF group, 77.78% (14 out of 18) after 1 year and 68,76% (11 out 16) after 5 years.

DISCUSSION

A very limited number of randomized clinical trials (RCTs) showed long-term outcomes of treatment with a follow–up of at least 5 years55. The present RCT

comparatively evaluated two flap designs – CAF and LPF - for the surgical treatment of maxillary buccal gingival recessions. To the best of our knowledge, no previous study have reported on the comparative longitudinal long-term results of these techniques. The results of the present study demonstrated that both flap designs were effective in treating maxillary single GR defects, 1 and 5-year after surgery, however, however siginificant differences were observed between the two surgical techniques 5 years after treatment (figure 2).

The success of any mucogingival surgical procedure depends on the elimination of etiologic factors, evaluation of interdental bone, correction of brushing habits, and, most importantly, the choice of the most appropriate surgical technique65.

Among the different types of flap design used in periodontal plastic surgery, the most frequent approach was the Coronally Advanced Flap55. On the other hand, flap

designs different from CAF as LPF showed a very limited number of RCTs and should be considered with caution in modern treatment55. Thus, additional studies

employing these flap designs are of paramount importance.

The results of present study demonstrated that the group treated with LPF presented a significantly increased WKT (4.41.5mm versus 1.90.7mm) over the CAF procedure, after 1 year, and after 5 years (4.71.5mm versus 1.70.6mm). CAF group had a higher percentage of complete RC after 1 year and the lowest

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percentage of complete RC after 5 years. Both groups exhibited similarly reduced BOP and VPS scores indicating a good standard of supragingival plaque control during the study period. The results of the present study agree with those of prior studies reporting on the clinical behavior of LPF and CAF9-49,53-58 demonstrating that

both techniques are acceptable methods for the treatment of localized gingival recessions.

The CAF group exhibited 88.88% of complete RC after 1 year and 56,25% after 5 years of the treated cases. These results were compatible with others in the literature 30,31,37,38,62. Zuchelli & DeSanctis31,38 who reported a mean 97% and

94% RC after 12 and 60 months, respectivelly. Trombelli et al30 reported 61% of RC

12 months after the CAF procedure. Similarly, lower degrees of root coverage (mean RC of 68.3% after 12 months and 44.9% after 60 months) were reported in a long-term study37 evaluating the CAF procedure. Lops et al.62 reported 69,2% of complete RC at 12 months after CAF procedure.

Leknes et al.48 compared the 6 years follow-up results of CAF with and without biodegradable membrane. After 6 years, the extend of root coverage achieved at 12 months was reduced by 0,5 mm for the membrane-treated sites and by 1mm for the non-membrane treated sites, revealing a significant relapse in the later group.

Pini-Prato et al.51 compared the clinical outcomes of CAF versus CAF plus connective tissue graft in the treatment of multiple gingival recessions using a split-mouth design over 5 years follow up. An apical shift of the gingival margin complete RC of 35% of CAF-treated sites was observed at the 5-years follow-up. Kuis et al.60 in a similar RCT observed that the value of complete RC tended to

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The fact that areas treated with CAF resulted in significantly less gains in the WKT when compared with those treated with LPF, may be due to the fact that the CAF procedure was performed in a single-stage procedure. Other studies11,12

demonstrated different, more positive, results in WKT probably because a free gingival graft (FGG) procedure was performed prior the CAF procedure. The potential of FGG in increasing the WKT is well documented4,8,50 and seems to explain

the increased WKT following the two-stage CAF procedures.

The gain of the WKT in LPF group may be related with the different results in complete RC after 5 years. Zuchelli & Wennstrom32 evaluated whether an increased thickness of the gingiva through the use of a free connective tissue graft, in conjunction with a coronally advanced flap procedure, may positively influence the treatment outcome with respect to (i) root coverage and (ii) long-term stability of the position of the soft tissue margin following treatment of recession type defects. But, the authors concluded that both surgical procedures after 2 years of follow-up resulted in similar degree of root coverage and that changes of tooth brushing habits may be of greater importance than increased gingival thickness for long-term maintenance of the surgically established position of the soft tissue margin.

The outcomes of the present RCT demonstrated that LPF and CAF procedures are surgical techniques that give good results in treatment of RC, with high degrees of mean RC, complete RC and PD .The LPF results in significantly increased WKT in the treated areas and greater stability after 5 years.

Conflict of interest statement - the present study received no funding. The authors do not possess any financial relationships that may pose a conflict of interest or potential conflict of interest and have no commercial relationship to any of the products and instruments employed.

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Table 1 – Baseline, 1 and 5 years clinical measurements in mm Treatments Baseline VPS BOP PD RECH WKT CAF 17±4 16±3 1.2±0.4 3.2±0.5 1.5±1.6 LPF 19±5 17±5 1.2±0.4 3.4±0.6 1.3±1.8 Significance n.s n.s n.s n.s n.s Treatments 1Year VPS BOP PD RECH WKT CAF 12±2 12±2 1.8±0.7 0.2±0.4 1.9±0.7 LPF 12±2 13±3 1.5±0.5 0.2±0.4 4.4±1.5 Significance n.s n.s n.s n.s * Treatments 5 Years VPS BOP PD RECH WKT CAF 12±2 11±2 1.6±0.6 0.5±0.6 1.7±0.6 LPF 12±2 12±2 1.3±0.5 0.4±0.4 4.7±1.5 Significance n.s n.s n.s n.s *

VPS = visual plaque score, BOP = bleeding on probing, PD = probing depth, RECH = recession height, WKT = width of keratinized tissue.

n.s = non-significant, * = P value < 0.01 (statistically significant).

Table 2 – Magnitude of changes of clinical measurements obtained 1 and 5-years after surgery in comparison with baseline (in mm)

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Treatments Variables (1-Year)

VPS BOP PD RECH WKT

CAF 3±3 1±3 0±0.5 3.0±0.6 0.4±1

LPF 3±2 2±3 0±0.7 3.3±0.5 3.1±1.5

Significance n.s n.s n.s n.s *

Treatments Variables (5-Years)

VPS BOP PD RECH WKT

CAF 0±2 1±2 0±0.5 0.1±0.3 0.1±0.2

LPF 0±2 0±3 0±0.7 0.2±0.4 3.4±1.4

Significance n.s n.s n.s n.s *

VPS = visual plaque score, BOP = bleeding on probing, PD = probing depth, RECH = recession height, WKT = width of keratinized tissue.

n.s = non-significant, * = P value < 0.05 (statistically significant).

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Figure 1 – Clinical aspect of a site treated by the coronally advanced flap procedure. A. Before treatment; B. 14-days after; follow-up 5-year

Figure 2 – Clinical aspect of site treated by the laterally-positioned flap procedure. A. Before treatment; B. 14-days after; follow-up 5-year

FOOTNOTES LEGENDS

* Perio-Set, Intensiv S.A, Grancia, Switzerland

** Tylenol 750, Jansen-Cilag Farmaceutica, Sao Paulo, Brazil *** CoePak, NJ, USA

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1. As técnicas de RPL e RPC são eficazes para o tratamento de recessões gengivais localizadas.

2. O RPL obtém maior percentual na quantidade de gengiva inserida na área tratada após 1 e 5 anos de tratamento.

3. O RPL obtém maior percentual de recobrimento radicular e percentual de recobrimento radicular completo na área tratada após 5 anos de tratamento.

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Referências

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