Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
12 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
22
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Thanh Si Ho, Doctor of Dental Surgery
- Número de teléfono: +84944510521
- Correo electrónico: sithanhlk2000@gmail.com
Ubicaciones de estudio
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Ho Chi Minh City (HCMC)
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Ho Chi Minh City, Ho Chi Minh City (HCMC), Vietnam, 700000
- Reclutamiento
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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Contacto:
- Thanh Si Ho, Doctor of Dental Surgery
- Número de teléfono: +84944510521
- Correo electrónico: sithanhlk2000@gmail.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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
Otros nombres:
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Comparador activo: 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
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Horizontal Clinical Attachment Level (HCAL)
Periodo de tiempo: Baseline and 6 months post-surgery
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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)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Plaque Index (PlI)
Periodo de tiempo: Baseline, 3 months, and 6 months post-surgery
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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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline and 6 months post-surgery
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Measured using a UNC-15 periodontal probe and a customized acrylic stent
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Baseline and 6 months post-surgery
|
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Gingival Recession (GR)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Baseline and 6 months post-surgery
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Evaluated using CBCT images and 3D segmentation software (ITK-SNAP)
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Baseline and 6 months post-surgery
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New Bone Gray Level
Periodo de tiempo: Baseline and 6 months post-surgery
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Evaluated using CBCT and ImageJ software to assess the density of newly formed bone
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Baseline and 6 months post-surgery
|
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TWEAK Biomarker Concentration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
25 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
9 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de agosto de 2026
Publicado por primera vez (Actual)
13 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26410 - ĐHYD
Plan de datos de participantes individuales (IPD)
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INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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