Advanced Platelet-Rich Fibrin and Coronally Advanced Flap for Gingival Recession Treatment
28 de maio de 2026 atualizado por: Nguyen Thi Minh Ngoc, University of Medicine and Pharmacy at Ho Chi Minh City
Clinical Effectiveness of Advanced Platelet-Rich Fibrin Combined With Coronally Advanced Flap for Gingival Recession Treatment
The goal of this clinical trial is to learn if adding a natural healing material works better to treat receding gums in adults. Receding gums is a condition where the gum tissue pulls back and exposes the tooth root. The main questions it aims to answer are:
- Does the addition of this healing material help cover the exposed root better than the standard surgery?
- Does the material help the gum tissue heal faster and become thicker? Researchers will compare a standard gum surgery alone to the standard gum surgery combined with Advanced Platelet-Rich Fibrin (A-PRF). A-PRF is a healing material made directly from the participant's own blood during the surgery. This comparison will help see if A-PRF improves the final cosmetic look and gum health.
Participants will:
- Have their blood drawn at the start of the surgery to create the A-PRF material.
- Receive the gum surgery with or without the A-PRF material. Visit the clinic for checkups and gum measurements at 1 week, 2 weeks, 4 weeks, 1 month, 3 months, and 6 months after the surgery.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Descrição detalhada
- Background and Rationale Gingival recession is a prevalent anatomical defect characterized by the apical shift of the gingival margin past the cementoenamel junction (CEJ). The Coronally Advanced Flap (CAF) is a reliable and widely applied technique for achieving esthetic root coverage. To overcome the limitations of autogenous grafts, Advanced Platelet-Rich Fibrin (A-PRF) has been introduced as a biologic adjunct. A-PRF is developed based on the Low-Speed Centrifugation Concept (LSCC), providing a porous 3D fibrin scaffold that continuously releases essential growth factors (such as PDGF, VEGF, and TGF-β) to accelerate soft tissue regeneration. This randomized, controlled, parallel-design clinical study aims to evaluate and compare the clinical efficacy of CAF combined with A-PRF versus CAF alone in treating localized gingival recession defects.
- Study Design and Sample Size The required sample size was calculated based on reference data from Padma et al. (2013) to achieve 80% power with a significance level of α = 0.05. Accounting for a 20% anticipated dropout rate, the final sample size was set to 11 defects per group, yielding a total of 22 gingival recession defects. Eligible participants must be 18 years or older, present with Cairo RT1 recession defects in the anterior or premolar region, and exhibit a keratinized tissue width ≥ 1 mm, keratinized tissue height ≥ 2 mm, and probing depth ≤ 2 mm. Defects are randomly allocated into the Test Group (CAF + A-PRF membrane) and the Control Group (CAF alone).
Clinical and Surgical Procedures
- A-PRF Preparation: At the initiation of the surgical procedure, 10 ml of venous blood is collected using a 24G butterfly needle into sterile glass tubes. Centrifugation is performed intra-operatively using a PRF Duo Quattro machine at 1500 rpm for 14 minutes following the LSCC protocol. The resulting A-PRF clot is carefully compressed in a PRF box to form a membrane with uniform thickness without damaging the cellular structure.
- Surgical Protocol: The surgical intervention follows the standardized CAF technique proposed by Martina Stefanini and Giovanni Zucchelli (2021). Following local anesthesia with Lidocaine 2% and mechanical root debridement, the root surface is chemically conditioned with EDTA 24% (PrefGel). In the Test Group, the intra-operatively prepared A-PRF membrane is stabilized over the defect using 6/0 resorbable sutures, whereas no graft is applied in the Control Group. The flap is then coronally advanced and secured tension-free with suspensory and interrupted sutures.
Data Collection and Statistical Analysis
- Clinical Assessments: Wound healing is evaluated using the Early Healing Index (EHI) at 1, 2, and 4 weeks post-surgery. Periodontal parameters-including Recession Depth (RD), Recession Width (RW), Clinical Attachment Level (CAL), Gingival Thickness (GT), and Height of Keratinized Tissue (HKT)-are measured at baseline, 1, 3, and 6 months by a calibrated, independent examiner using a UNC-15 probe and customized acrylic stents. The Mean Root Coverage (MRC), Complete Root Coverage (CRC), and Root Coverage Esthetic Score (RES) will also be calculated.
- Statistical Analysis: Data is processed using JASP version 0.96. The Shapiro-Wilk test is utilized to check for normal distribution. Intra-group variations over time are analyzed using the Friedman test followed by Conover post-hoc analysis with Bonferroni correction. Inter-group differences are assessed using the Mann-Whitney U test, with statistical significance strictly defined as p < 0.05.
Tipo de estudo
Intervencional
Inscrição (Real)
11
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.
Locais de estudo
-
-
-
Ho Chi Minh City, Vietnã, 70000
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
-
-
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:
- Patients aged 18 years or older.
- Presence of 1 to 2 gingival recession defects requiring treatment, classified as RT1 (Cairo 2011).
- Gingival recession defects located in the anterior or premolar regions of the maxilla or mandible.
- Gingival thickness ≥ 1 mm. Keratinized tissue width ≥ 2 mm. Probing depth ≤ 2 mm.
- Good oral hygiene, demonstrated by a mean Gingival Index (GI) ≤ 1 and a mean full-mouth Plaque Index (PI) ≤ 1.
Exclusion Criteria:
- Patients with systemic diseases affecting wound healing (e.g., diabetes mellitus, coagulation disorders).
- Pregnant or lactating women.
- Patients with a smoking habit.
- Teeth with interproximal bone loss.
- Severely malpositioned teeth.
- Presence of caries or cervical restorations at the experimental site.
- History of previous periodontal surgery at the selected sites.
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Experimental: CAF + A-PRF
Patients in this group will receive the Coronally Advanced Flap (CAF) surgical technique combined with an Advanced Platelet-Rich Fibrin (A-PRF) membrane to treat the localized gingival recession defect.
The A-PRF membrane is prepared intra-operatively from the patient's own venous blood.
|
The surgical procedure involves mechanical root debridement and chemical conditioning with 24% EDTA.
An Advanced Platelet-Rich Fibrin (A-PRF) membrane, prepared intra-operatively from the patient's venous blood using low-speed centrifugation (1500 rpm for 14 minutes), is adapted over the exposed root surface and secured with resorbable sutures.
A Coronally Advanced Flap (CAF) is then mobilized, advanced coronally to completely cover the A-PRF membrane and the cementoenamel junction (CEJ), and secured.
|
|
Comparador Ativo: Active Comparator: CAF alone
Patients in this group will receive the Coronally Advanced Flap (CAF) surgical technique alone, without the addition of any grafting material or A-PRF membrane, to treat the localized gingival recession defect.
|
The surgical procedure involves mechanical root debridement and chemical conditioning with 24% EDTA.
A Coronally Advanced Flap (CAF) is mobilized and advanced coronally to completely cover the exposed root surface and the cementoenamel junction (CEJ) without the use of any additional grafting material or A-PRF membrane.
The flap is then secured.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Root Coverage (MRC)
Prazo: Baseline, 1 month, 3 months, and 6 months post-surgery
|
The percentage of root coverage calculated from the reduction in Recession Depth (RD).
RD is measured from the cementoenamel junction (CEJ) to the gingival margin using a standardized UNC-15 periodontal probe and customized acrylic stents to ensure reproducible angulation.
|
Baseline, 1 month, 3 months, and 6 months post-surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gingival Thickness (GT)
Prazo: Baseline, 1 month, 3 months, and 6 months post-surgery
|
The thickness of the soft tissue measured 1 mm apical to the gingival margin.
This is evaluated using an endodontic file with a rubber stop (guided by an acrylic stent) and measured with a digital caliper for high precision.
|
Baseline, 1 month, 3 months, and 6 months post-surgery
|
|
Root Coverage Esthetic Score (RES)
Prazo: 6 months post-surgery
|
A professional esthetic evaluation of the treated area assessing five variables: gingival margin position, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color.
|
6 months post-surgery
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Investigador principal: Ngoc TM Nguyen, DDS, University of Medicine and Pharmacy at Ho Chi Minh City
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 (Real)
1 de agosto de 2025
Conclusão Primária (Estimado)
30 de junho de 2026
Conclusão do estudo (Estimado)
30 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
28 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de maio de 2026
Primeira postagem (Real)
3 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 3151/ĐHYD-HĐĐĐ
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The raw data will be available upon reasonable request to the corresponding author, provided that the request is aligned with the ethical approval and patient consent forms to ensure participant anonymity and data privacy.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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 .