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The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession.

30 de agosto de 2026 atualizado por: Mai Magdy Abu El Eneen, Cairo University

The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession: A Randomized Clinical Trial

The aim of this randomized clinical trial will be to assess the change in recession depth after using a vertically coronally advanced flap with sub-epithelial connective tissue graft compared to a coronally advanced flap with sub-epithelial connective tissue graft after 6 months.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

To test new approaches for root coverage for the treatment of RT1 and RT2 gingival recession.

Tipo de estudo

Intervencional

Inscrição (Estimado)

26

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • • Age ≥ 18 years.

    • Systemically healthy.
    • Non-smokers.
    • Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
    • Presence of identifiable CEJ.
    • Absence of non-carious cervical lesions.
    • Mature permanent tooth in the aesthetic zone.
    • At least one recession defect type RT1 and/ or RT2 in the upper or lower jaw.
    • Thin gingival phenotype (GT < 0.8 mm) via probe transparency method.
    • A minimum of (2 mm KTW).

Exclusion Criteria:

  • Any systemic disease.
  • Pregnancy or lactation.
  • Cairo RT3 recession defects.
  • Teeth with active orthodontic treatment.
  • Previous periodontal surgery in the area.
  • Use of any drugs that might lead to gingival enlargement.
  • Smoking.
  • Caries, restoration, mobility, unstable endodontic condition, and malocclusion in teeth undergoing treatment.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Coronally Advanced flap combined with sub-epithelial connective tissue graft
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
Procedimento: Coronally Advanced flap combined with sub-epithelial connective tissue graft
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
Experimental: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.
Procedimento: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in recession depth (mm)
Prazo: at Baseline and 6 months
Change in recession depth in millimeters will be measured using a UNC-15 periodontal probe as the distance from the cementoenamel junction towards the most apical extension of the gingival margin
at Baseline and 6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Gingival Recession Width (mm)
Prazo: at baseline and 6 months
Gingival recession width will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the mesial to the distal papillae along the cementoenamel junction.
at baseline and 6 months
Keratinized Tissue Width (mm)
Prazo: at Baseline and 6 months
Keratinized tissue width will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin at the deepest recession point till the mucogingival junction (MGJ), which will be identified using the roll technique
at Baseline and 6 months
Keratinized Tissue Height (mm)
Prazo: at Baseline and 6 months
Keratinized tissue height will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin to the mucogingival junction.
at Baseline and 6 months
Probing Depth (mm)
Prazo: at Baseline and 6 months
Probing depth will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the gingival crevice to the marginal gingiva.
at Baseline and 6 months
Gingival Thickness (mm)
Prazo: at Baseline and 6 months
Gingival thickness will be measured in millimetres using endodontic spreader no. 15 with a silicon disk stopper will be performed apical to the gingival margin by 2 mm at the middle of the long axis of the tooth mesio-distally using a UNC-15 periodontal probe.The depth of penetration will be measured using a ruler with precision up to the nearest 0.5 mm.
at Baseline and 6 months
Recession Reduction (mm)
Prazo: at Baseline and 6 months
Recession reduction will be calculated by comparing the initial gingival recession depth and gingival depth after treatment using a UNC-15 periodontal probe.
at Baseline and 6 months
Clinical Attachment Level (mm)
Prazo: at Baseline and 6 months
Clinical attachment level will be identified using a UNC-15 periodontal probe as the distance from the cementoenamel junction to the bottom of the gingival sulcus.
at Baseline and 6 months
Complete Root Coverage (%)
Prazo: at 6 months
Complete root coverage will be assessed by calculating the percentage of cases exhibiting a gingival margin that was either level with or positioned coronally to the cementoenamel junction in each group.
at 6 months
Bleeding on Probing (+/-)
Prazo: at Baseline and 6 months
Bleeding on probing (BOP) will be measured using an UNC-15 periodontal probe, gently probing the gingival crevice, beginning inter-proximally from the mesial aspect and moving towards the distal. A positive finding for BOP will be recorded when bleeding occurred within 10s.
at Baseline and 6 months
Plaque Index (scores 0, 1, 2, 3)
Prazo: at Baseline and 6 months

Plaque index will be determined by drying the teeth in each quadrant with a gentle air blast, where the visibility of dental plaque and supragingival calculus will be noted. Each four tooth surfaces (buccal, lingual, mesial and distal) will be scored from 0 to 3, then scores of the four areas will be added and divided by four to give the average plaque index for each tooth.

Scores:

0 : No plaque

1 : A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.

2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.

3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
at Baseline and 6 months
Post-Operative Pain (VAS) Visual Analogue Scale Questionnaire
Prazo: Surgical day and days 1, 3, 7, and 14 after surgery
Post-operative pain will be indirectly evaluated on the basis of the mean consumption (in mg) of analgesics (ibuprofen). A questionnaire will be given to each patient; it will be divided into two parts to be completed in different time periods: the first part, regarding the post-operative discomfort and bleeding will be completed 1 week after the surgery based on a visual analogue scale of 100 mm.Postoperative pain will be assessed using a 100-mm Visual Analogue Scale, ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with higher scores indicating greater pain.
Surgical day and days 1, 3, 7, and 14 after surgery
Patient Esthetic Satisfaction (RES) Root Coverage Esthetic Score
Prazo: at 6 months
Patient aesthetic satisfaction will be assessed using the root coverage esthetic score (RES) at the 6 months follow up visit. The following five parameters will be evaluated: gingival margin level (0 = failure of root coverage; 3 = partial root coverage; 6 = complete root coverage), marginal tissue contour (0 = irregular; 1 = proper), soft tissue texture (0 = presence of scar/keloid; 1 = absence of scar/ keloid), mucogingival junction (MGJ) (0 = MGJ not aligned; 1 = MGJ aligned), and gingival color (0 = color differs from adjacent teeth; 1 = normal color and integration). A total RES score will be calculated by adding these 5 components
at 6 months
Mean Percentage of Root Coverage (mRC) %
Prazo: (subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100
Mean percentage of root coverage (mRC) will be calculated after 6 months as the percentage reduction in gingival recession depth from baseline to 6 months post-treatment, using the following formula: mRC (%) = [(RD₀ - RD6) / RD₀] × 100, where RD₀ represents the gingival recession depth at baseline and RD6 represents the gingival recession depth at 6 months post-treatment.
(subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cairo University

Investigadores

  • Investigador principal: Mai Magdy Abu El Eneen, PHD candidate, Cairo University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de novembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

11 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de agosto de 2026

Primeira postagem (Real)

3 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • preliminary decision

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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