An interventional study of A-PRF+ and Xenograft and Collagen Membrane and Xenograft in Periodontitis and Furcation Defects, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 22 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
Open flap debridement followed by the application of A-PRF+ mixed with xenograft (Cerabone), covered by an A-PRF+ membrane
Procedure: A-PRF+ and Xenograft
Open flap debridement followed by the application of xenograft (Cerabone) covered by a resorbable collagen membrane
Procedure: Collagen Membrane and Xenograft
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
Also known as: Advanced Platelet-Rich Fibrin plus, Cerabone, A-PRF+
Open flap debridement surgery. The furcation defect is filled with bovine xenograft (Cerabone) and covered with a resorbable collagen membrane before suturing
Also known as: Guided Tissue Regeneration, Bio-Gide, Cerabone, Collagen membrane
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
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
Plan to share: Undecided
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