Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
A-PRF+ and Xenograft
Procedure/SurgeryOpen 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
Collagen Membrane and Xenograft
Procedure/SurgeryOpen flap debridement surgery. The furcation defect is filled with bovine xenograft (Cerabone) and covered with a resorbable collagen membrane before suturing
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: A-PRF+ and XenograftExperimental treatment 1 intervention
Group B: Collagen Membrane and XenograftActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-surgery2
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-surgerySecondary outcomes
1
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-surgery2
Gingival Index (GI)
Assessed using the Loe and Silness (1963) criteria to evaluate gingival inflammation
Time frame
Baseline and 6 months post-surgery3
Vertical Clinical Attachment Level (VCAL)
Measured using a UNC-15 periodontal probe and a customized acrylic stent
Time frame
Baseline and 6 months post-surgery4
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-surgerySponsors and contacts
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Source ClinicalTrials.gov