Furcation Defects, Periodontitis
Conditions
Keywords
A-PRF plus, A-PRF+, Xenograft, Mandibular Molar, Guided Tissue Regeneration, TWEAK, biomarker, collagen membrane
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.
Detailed description
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.
Interventions
PROCEDUREA-PRF+ 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
PROCEDURECollagen Membrane and Xenograft
Open flap debridement surgery. The furcation defect is filled with bovine xenograft (Cerabone) and covered with a resorbable collagen membrane before suturing
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Eligible teeth are randomly assigned in parallel to either the test group (A-PRF+ and xenograft) or the control group (collagen membrane and xenograft
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing Pocket Depth (PPD) | 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 |
| Horizontal Clinical Attachment Level (HCAL) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index (PlI) | Baseline, 3 months, and 6 months post-surgery | Assessed at 4 sites per tooth using the Loe and Silness (1963) criteria |
| Gingival Index (GI) | Baseline and 6 months post-surgery | Assessed using the Loe and Silness (1963) criteria to evaluate gingival inflammation |
| Vertical Clinical Attachment Level (VCAL) | Baseline and 6 months post-surgery | Measured using a UNC-15 periodontal probe and a customized acrylic stent |
| Gingival Recession (GR) | Baseline, 3 months, and 6 months post-surgery | Evaluated using a 3D intraoral scanner (3Shape TRIOS) and a customized acrylic stent |
| Radiographic Vertical Bone Level (VBL) | Baseline and 6 months post-surgery | Measured on Cone Beam Computed Tomography (CBCT) images from the furcation fornix to the base of the defect |
| Furcation Defect Volume | Baseline and 6 months post-surgery | Evaluated using CBCT images and 3D segmentation software (ITK-SNAP) |
| New Bone Gray Level | Baseline and 6 months post-surgery | Evaluated using CBCT and ImageJ software to assess the density of newly formed bone |
| TWEAK Biomarker Concentration | Baseline, 1 month, and 3 months post-surgery | Measured in Gingival Crevicular Fluid (GCF) using Enzyme-Linked Immunosorbent Assay (ELISA) |
| Post-operative Patient Satisfaction | 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 |
| Post-operative Pain Perception | 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" |
| Post-operative Painkiller Consumption | Up to 3 days post-surgery | Recorded as the total number of analgesic tablets consumed by the patient |
Countries
Vietnam
Contacts
CONTACTThanh Si Ho, Doctor of Dental Surgery
Outcome results
None listed