Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Efficacy of Platelet-Rich Fibrin Combined With Xenograft in the Treatment of Mandibular Molar Furcation Involvements
1 other identifier
interventional
22
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2026
CompletedFirst Submitted
Initial submission to the registry
August 9, 2026
CompletedFirst Posted
Study publicly available on registry
August 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
August 13, 2026
August 1, 2026
11 months
August 9, 2026
August 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Baseline and 6 months post-surgery
Secondary Outcomes (11)
Plaque Index (PlI)
Baseline, 3 months, and 6 months post-surgery
Gingival Index (GI)
Baseline and 6 months post-surgery
Vertical Clinical Attachment Level (VCAL)
Baseline and 6 months post-surgery
Gingival Recession (GR)
Baseline, 3 months, and 6 months post-surgery
Radiographic Vertical Bone Level (VBL)
Baseline and 6 months post-surgery
- +6 more secondary outcomes
Study Arms (2)
A-PRF+ and Xenograft
EXPERIMENTALOpen flap debridement followed by the application of A-PRF+ mixed with xenograft (Cerabone), covered by an A-PRF+ membrane
Collagen Membrane and Xenograft
ACTIVE COMPARATOROpen flap debridement followed by the application of xenograft (Cerabone) covered by a resorbable collagen membrane
Interventions
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
Open flap debridement surgery. The furcation defect is filled with bovine xenograft (Cerabone) and covered with a resorbable collagen membrane before suturing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City (HCMC), 700000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor of Dental Surgery
Study Record Dates
First Submitted
August 9, 2026
First Posted
August 13, 2026
Study Start
June 25, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
August 13, 2026
Record last verified: 2026-08