Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements

University of Medicine and Pharmacy at Ho Chi Minh City22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Horizontal Clinical Attachment Level (HCAL)

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

Time frame: Baseline and 6 months post-surgery

Probing Pocket Depth (PPD)

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

Time frame: Baseline and 6 months post-surgery

Secondary Outcomes

Plaque Index (PlI)

Assessed at 4 sites per tooth using the Loe and Silness (1963) criteria

Time frame: Baseline, 3 months, and 6 months post-surgery

Gingival Index (GI)

Assessed using the Loe and Silness (1963) criteria to evaluate gingival inflammation

Time frame: Baseline and 6 months post-surgery

Vertical Clinical Attachment Level (VCAL)

Measured using a UNC-15 periodontal probe and a customized acrylic stent

Time frame: Baseline and 6 months post-surgery

Gingival Recession (GR)

Evaluated using a 3D intraoral scanner (3Shape TRIOS) and a customized acrylic stent

Time frame: Baseline, 3 months, and 6 months post-surgery

Radiographic Vertical Bone Level (VBL)

Measured on Cone Beam Computed Tomography (CBCT) images from the furcation fornix to the base of the defect

Time frame: Baseline and 6 months post-surgery

Furcation Defect Volume

Evaluated using CBCT images and 3D segmentation software (ITK-SNAP)

Time frame: Baseline and 6 months post-surgery

New Bone Gray Level

Evaluated using CBCT and ImageJ software to assess the density of newly formed bone

Time frame: Baseline and 6 months post-surgery

TWEAK Biomarker Concentration

Measured in Gingival Crevicular Fluid (GCF) using Enzyme-Linked Immunosorbent Assay (ELISA)

Time frame: Baseline, 1 month, and 3 months post-surgery

Post-operative Pain Perception

Assessed using a 10-cm Visual Analog Scale (VAS) where 0 indicates "no pain" and 10 indicates "worst imaginable pain"

Time frame: 12 hours, 1 day, and 3 days post-surgery

Post-operative Painkiller Consumption

Recorded as the total number of analgesic tablets consumed by the patient

Time frame: Up to 3 days post-surgery

Post-operative Patient Satisfaction

Evaluated using a 5-point Likert scale (from 1 = very dissatisfied to 5 = very satisfied) regarding post-operative swelling and chewing ability

Time frame: 3 days and 7 days post-surgery

Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts