Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City (HCMC), 700000, Vietnam
Location status: Recruiting
NCT Number: NCT07764029
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ho Chi Minh City, Ho Chi Minh City (HCMC), 700000, Vietnam
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: 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
Other names: Guided Tissue Regeneration, Bio-Gide, Cerabone, Collagen membrane
Time frame: Baseline and 6 months post-surgery
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
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, 3 months, and 6 months post-surgery
Assessed at 4 sites per tooth using the Loe and Silness (1963) criteria
Time frame: Baseline and 6 months post-surgery
Assessed using the Loe and Silness (1963) criteria to evaluate gingival inflammation
Time frame: Baseline and 6 months post-surgery
Measured using a UNC-15 periodontal probe and a customized acrylic stent
Time frame: Baseline, 3 months, and 6 months post-surgery
Evaluated using a 3D intraoral scanner (3Shape TRIOS) and a customized acrylic stent
Time frame: Baseline and 6 months post-surgery
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
Evaluated using CBCT images and 3D segmentation software (ITK-SNAP)
Time frame: Baseline and 6 months post-surgery
Evaluated using CBCT and ImageJ software to assess the density of newly formed bone
Time frame: Baseline, 1 month, and 3 months post-surgery
Measured in Gingival Crevicular Fluid (GCF) using Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: 12 hours, 1 day, and 3 days post-surgery
Assessed using a 10-cm Visual Analog Scale (VAS) where 0 indicates "no pain" and 10 indicates "worst imaginable pain"
Time frame: Up to 3 days post-surgery
Recorded as the total number of analgesic tablets consumed by the patient
Time frame: 3 days and 7 days post-surgery
Evaluated using a 5-point Likert scale (from 1 = very dissatisfied to 5 = very satisfied) regarding post-operative swelling and chewing ability
Contact information is provided by the study sponsor or research team.
University of Medicine and Pharmacy at Ho Chi Minh City
Other
Efficacy of Platelet-Rich Fibrin Combined With Xenograft in the Treatment of Mandibular Molar Furcation Involvements
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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