Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
12 de agosto de 2026 atualizado por: Thanh Si Ho, University of Medicine and Pharmacy at Ho Chi Minh City
Efficacy of Platelet-Rich Fibrin Combined With Xenograft in the Treatment of Mandibular Molar Furcation Involvements
The purpose of this randomized controlled clinical trial is to compare the effectiveness of advanced platelet-rich fibrin (A-PRF+) combined with xenograft versus a collagen membrane combined with xenograft in the treatment of degree II furcation involvements in mandibular first molars.
Adult patients with periodontitis will randomly receive either the A-PRF+ treatment or the collagen membrane treatment during periodontal flap surgery.
The study will evaluate clinical periodontal healing, bone regeneration using 3D imaging (CBCT), patient comfort (pain levels and satisfaction), and changes in the TWEAK biomarker in gingival crevicular fluid over a 6-month period.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
Furcation involvements in molars pose a significant challenge in periodontal therapy. This study aims to evaluate a regenerative approach using advanced platelet-rich fibrin (A-PRF+) to enhance clinical and radiographic outcomes. The study includes adult patients with periodontitis who have a degree II furcation involvement (Hamp 1975) on a mandibular molar, with a probing pocket depth of ≥ 5mm after initial non-surgical therapy.
Eligible patients will be randomly allocated to one of two surgical interventions:
Test Group: Open flap debridement followed by the application of A-PRF+ mixed with a xenograft (Cerabone), covered by an A-PRF+ membrane.
Control Group: Open flap debridement followed by the application of a xenograft (Cerabone) covered by a resorbable collagen membrane (Guided Tissue Regeneration).
Clinical parameters including Plaque Index (PlI), Gingival Index (GI), Probing Pocket Depth (PPD), Gingival Recession (GR), Vertical Clinical Attachment Level (VCAL), and Horizontal Clinical Attachment Level (HCAL) will be recorded at baseline and 6 months post-surgery using customized acrylic stents.
Radiological assessments using Cone Beam Computed Tomography (CBCT) will measure furcation volume, bone fill, and new bone gray level at baseline and 6 months. Patient-reported outcomes, including pain perception (VAS), painkiller consumption, and post-operative satisfaction (Likert scale), will be monitored during the first week. Additionally, Gingival Crevicular Fluid (GCF) samples will be collected to analyze the concentration of the TWEAK biomarker via ELISA at baseline, 1 month, and 3 months post-surgery.
Tipo de estudo
Intervencional
Inscrição (Estimado)
22
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
- Nome: Thanh Si Ho, Doctor of Dental Surgery
- Número de telefone: +84944510521
- E-mail: sithanhlk2000@gmail.com
Locais de estudo
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Ho Chi Minh City (HCMC)
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Ho Chi Minh City, Ho Chi Minh City (HCMC), Vietnã, 700000
- Recrutamento
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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Contato:
- Thanh Si Ho, Doctor of Dental Surgery
- Número de telefone: +84944510521
- E-mail: sithanhlk2000@gmail.com
-
-
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 over 18 years old
- Patients diagnosed with periodontitis who have completed non-surgical treatment: scaling and root planing
- Patients attending a follow-up visit at least 5 weeks after non-surgical treatment, demonstrating compliance and good oral hygiene cooperation
- Presence of a mandibular molar with a Degree II furcation involvement according to Hamp (1975), presenting a residual periodontal pocket at the buccal site (PPD ≥ 5mm) after non-surgical treatment, and showing radiolucency in the furcation area on CBCT imaging
- Plaque Index (PlI) < 1 following non-surgical treatment
- Width of keratinized gingiva ≥ 2mm
- Teeth with furcation defects where gingival recession does not extend apically beyond the buccal furcation fornix (no supragingival furcation exposure)
- Teeth without occlusal trauma, pulpal or periapical pathologies, and no combined periodontic-endodontic lesions
- Degree II furcation involvement according to Hamp (1975) and Subclass A or B according to Tarnow and Fletcher (1984)
- The defect is located apical to the interproximal alveolar bone crest on CBCT imaging
Exclusion Criteria:
- Patients with systemic diseases affecting periodontal treatment outcomes, such as: diabetes mellitus, heart disease requiring anticoagulant therapy, blood disorders, immunodeficiency, etc
- Pregnant or lactating patients
- Patients who have used antibiotics or any other medications affecting periodontal treatment outcomes within the last 6 months
- Patients who smoke tobacco.
- Patients who have used aspirin or medications affecting blood coagulation within 2 weeks prior to the blood collection for PRF preparation
- Patients with a history of allergy to local anesthetics
- Defects associated with grade II tooth mobility that has not been splinted, or grade III tooth mobility according to Miller (2014)
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 |
|---|---|
|
Experimental: A-PRF+ and Xenograft
Open flap debridement followed by the application of A-PRF+ mixed with xenograft (Cerabone), covered by an A-PRF+ membrane
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Open flap debridement surgery.
The furcation defect is filled with a mixture of A-PRF+ fragments and bovine xenograft (Cerabone), and then covered with an A-PRF+ membrane before suturing
Outros nomes:
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Comparador Ativo: Collagen Membrane and Xenograft
Open flap debridement followed by the application of xenograft (Cerabone) covered by a resorbable collagen membrane
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Open flap debridement surgery.
The furcation defect is filled with bovine xenograft (Cerabone) and covered with a resorbable collagen membrane before suturing
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Horizontal Clinical Attachment Level (HCAL)
Prazo: Baseline and 6 months post-surgery
|
HCAL is evaluated using a Nabers probe and a customized acrylic stent to measure the horizontal penetration from the buccal furcation entrance to the deepest point of the defect
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Baseline and 6 months post-surgery
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Probing Pocket Depth (PPD)
Prazo: Baseline and 6 months post-surgery
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PPD is measured using a UNC-15 periodontal probe and a customized acrylic stent to ensure measurement reproducibility.
The measurement is recorded at the buccal aspect of the involved tooth
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Baseline and 6 months post-surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Plaque Index (PlI)
Prazo: Baseline, 3 months, and 6 months post-surgery
|
Assessed at 4 sites per tooth using the Loe and Silness (1963) criteria
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Baseline, 3 months, and 6 months post-surgery
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Gingival Index (GI)
Prazo: Baseline and 6 months post-surgery
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Assessed using the Loe and Silness (1963) criteria to evaluate gingival inflammation
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Baseline and 6 months post-surgery
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Vertical Clinical Attachment Level (VCAL)
Prazo: Baseline and 6 months post-surgery
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Measured using a UNC-15 periodontal probe and a customized acrylic stent
|
Baseline and 6 months post-surgery
|
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Gingival Recession (GR)
Prazo: Baseline, 3 months, and 6 months post-surgery
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Evaluated using a 3D intraoral scanner (3Shape TRIOS) and a customized acrylic stent
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Baseline, 3 months, and 6 months post-surgery
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Radiographic Vertical Bone Level (VBL)
Prazo: Baseline and 6 months post-surgery
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Measured on Cone Beam Computed Tomography (CBCT) images from the furcation fornix to the base of the defect
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Baseline and 6 months post-surgery
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Furcation Defect Volume
Prazo: Baseline and 6 months post-surgery
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Evaluated using CBCT images and 3D segmentation software (ITK-SNAP)
|
Baseline and 6 months post-surgery
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New Bone Gray Level
Prazo: Baseline and 6 months post-surgery
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Evaluated using CBCT and ImageJ software to assess the density of newly formed bone
|
Baseline and 6 months post-surgery
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TWEAK Biomarker Concentration
Prazo: Baseline, 1 month, and 3 months post-surgery
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Measured in Gingival Crevicular Fluid (GCF) using Enzyme-Linked Immunosorbent Assay (ELISA)
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Baseline, 1 month, and 3 months post-surgery
|
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Post-operative Pain Perception
Prazo: 12 hours, 1 day, and 3 days post-surgery
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Assessed using a 10-cm Visual Analog Scale (VAS) where 0 indicates "no pain" and 10 indicates "worst imaginable pain"
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12 hours, 1 day, and 3 days post-surgery
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Post-operative Painkiller Consumption
Prazo: Up to 3 days post-surgery
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Recorded as the total number of analgesic tablets consumed by the patient
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Up to 3 days post-surgery
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Post-operative Patient Satisfaction
Prazo: 3 days and 7 days post-surgery
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Evaluated using a 5-point Likert scale (from 1 = very dissatisfied to 5 = very satisfied) regarding post-operative swelling and chewing ability
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3 days and 7 days post-surgery
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Colaboradores e Investigadores
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Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Real)
25 de junho de 2026
Conclusão Primária (Estimado)
1 de junho de 2027
Conclusão do estudo (Estimado)
30 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
9 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de agosto de 2026
Primeira postagem (Real)
13 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26410 - ĐHYD
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