- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07591142
Titanium-prepared Platelet-rich Fibrin for Treatment of Gingival Recession Using the VISTA Technique
Titanium-prepared Platelet-rich Fibrin Versus Connective Tissue Graft in Gingival Recession Treatment: a Split-mouth Randomized Clinical Trial
Visão geral do estudo
Status
Condições
Descrição detalhada
Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, resulting in root exposure, dentin hypersensitivity, esthetic concerns, and increased susceptibility to root caries. Connective tissue grafts (CTG) are widely considered the gold standard for root coverage procedures due to their predictable clinical outcomes. However, CTG requires harvesting tissue from a secondary surgical donor site, which may increase postoperative discomfort and patient morbidity.
Titanium-prepared platelet-rich fibrin (T-PRF) is a second-generation autologous platelet concentrate prepared using titanium tubes, which may enhance fibrin network quality and improve soft tissue healing and regeneration. T-PRF has been proposed as a less invasive alternative to CTG in periodontal plastic surgery.
The present study is designed as a split-mouth randomized controlled clinical trial to compare T-PRF and CTG in the treatment of bilateral Miller Class I and II gingival recession defects using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique. Twenty systemically healthy adult participants with symmetrical gingival recession defects will be enrolled. Each participant will receive both interventions: one side of the mouth will be randomly assigned to treatment with VISTA combined with CTG, while the contralateral side will receive VISTA combined with T-PRF.
Randomization will be performed using a computer-generated allocation sequence prepared by an independent investigator. Due to the nature of the interventions, operator blinding is not feasible; however, all clinical measurements and outcome assessments will be conducted by a blinded examiner.
Clinical parameters including gingival recession depth, attached gingival width, probing depth, and relative attachment level will be measured at baseline, 3 months, and 6 months postoperatively using a UNC-15 periodontal probe. Early wound healing will be assessed at 1, 2, and 4 weeks using a healing index. Patient-reported satisfaction and postoperative outcomes will be evaluated using a visual analog scale (VAS).
The study aims to determine whether T-PRF can provide comparable clinical and patient-centered outcomes to CTG while reducing the morbidity associated with donor site harvesting.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Damascus, Síria
- School of Dental Medicine
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Systemically healthy
- Bilateral gingival recession
- Good oral hygiene
Exclusion Criteria:
- Smokers
- Pregnant/lactating women
- Systemic diseases affecting healing
- Previous surgery
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: VISTA + Titanium-Prepared Platelet-Rich Fibrin (T-PRF)
Sites allocated to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with titanium-prepared platelet-rich fibrin (T-PRF).
T-PRF membranes will be prepared from autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled gingival tissue.
|
The gingival recession defects assigned to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with titanium-prepared platelet-rich fibrin (T-PRF).
T-PRF membranes will be prepared from the participant's autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled flap.
|
|
Comparador Ativo: VISTA + Connective Tissue Graft (CTG)
Sites allocated to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with an autogenous connective tissue graft (CTG) harvested from the palatal donor site and placed beneath the tunneled gingival tissue for root coverage.
|
The gingival recession defects assigned to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with an autogenous connective tissue graft (CTG).
The graft will be harvested from the palatal donor site and positioned beneath the tunneled gingival tissue to achieve root coverage and soft tissue augmentation.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gingival Recession Depth
Prazo: Baseline, 3 months, and 6 months postoperatively.
|
Change in gingival recession depth measured in millimeters (mm) from the cementoenamel junction to the free gingival margin using a UNC-15 periodontal probe.
Lower values indicate better root coverage outcomes.
|
Baseline, 3 months, and 6 months postoperatively.
|
|
Width of Attached Gingiva
Prazo: Baseline, 3 months, and 6 months postoperatively.
|
Change in the width of attached gingiva measured in millimeters (mm) using a UNC-15 periodontal probe.
Higher values indicate improved gingival tissue augmentation and periodontal stability.
|
Baseline, 3 months, and 6 months postoperatively.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Periodontal Probing Depth
Prazo: Baseline, 3 months, and 6 months postoperatively.
|
Change in periodontal probing depth measured in millimeters (mm) using a UNC-15 periodontal probe at treated sites.
Lower values indicate better periodontal health.
|
Baseline, 3 months, and 6 months postoperatively.
|
|
Relative Clinical Attachment Level
Prazo: Baseline, 3 months, and 6 months postoperatively.
|
Change in relative clinical attachment level measured in millimeters (mm) using a UNC-15 periodontal probe.
Lower values indicate improved periodontal attachment.
|
Baseline, 3 months, and 6 months postoperatively.
|
|
Early Wound Healing Index
Prazo: 1 week, 2 weeks, and 4 weeks postoperatively.
|
Early wound healing assessed clinically using the Early Healing Index (EHI). The scale ranges from 1 to 5, where: 1 = Complete flap closure without fibrin line (best healing) 5 = Incomplete flap closure with complete tissue necrosis (worst healing) Lower scores indicate better healing outcomes. |
1 week, 2 weeks, and 4 weeks postoperatively.
|
|
Patient Satisfaction
Prazo: 3 months and 6 months postoperatively.
|
Patient satisfaction assessed using a Visual Analog Scale (VAS). The scale ranges from 0 to 10, where: 0 = Completely dissatisfied 10 = Completely satisfied Higher scores indicate greater patient satisfaction with the treatment outcome. |
3 months and 6 months postoperatively.
|
|
Postoperative Pain
Prazo: 1 week and 2 weeks postoperatively.
|
Postoperative pain assessed using a Visual Analog Scale (VAS). The scale ranges from 0 to 10, where: 0 = No pain 10 = Worst imaginable pain Lower scores indicate less postoperative pain and discomfort. |
1 week and 2 weeks postoperatively.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Saleh Al Kurdi, PhD, Arab International University
- Investigador principal: Rania Daadoush, DDs, Damascus University
- Cadeira de estudo: Tarek Qasem, PhD, Damascus University
Publicações e links úteis
Publicações Gerais
- Miller PD Jr. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. No abstract available.
- Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
- Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Yaprak E, Toker H, Firatli E. A novel platelet concentrate: titanium-prepared platelet-rich fibrin. Biomed Res Int. 2014;2014:209548. doi: 10.1155/2014/209548. Epub 2014 Jan 21.
- Chambrone L, Sukekava F, Araujo MG, Pustiglioni FE, Chambrone LA, Lima LA. Root-coverage procedures for the treatment of localized recession-type defects: a Cochrane systematic review. J Periodontol. 2010 Apr;81(4):452-78. doi: 10.1902/jop.2010.090540.
- Abdelhaleem M, Saleh W, Elmeadawy S. Treatment of gingival recession with vestibular incision subperiosteal tunnel access and advanced platelet-rich fibrin. BMC Oral Health. 2025 Jan 14;25(1):63. doi: 10.1186/s12903-024-05398-w.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DN-14072025-3109
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .