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NCT Number: NCT07764029

Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Location contact

Thanh Si Ho, Doctor of Dental Surgery

CONTACT

[email protected]

+84944510521

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

A-PRF+ and Xenograft

Procedure

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+

Collagen Membrane and Xenograft

Procedure

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

Primary outcomes

  1. Horizontal Clinical Attachment Level (HCAL)

    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

  2. Probing Pocket Depth (PPD)

    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

Secondary outcomes

  1. Plaque Index (PlI)

    Time frame: Baseline, 3 months, and 6 months post-surgery

    Assessed at 4 sites per tooth using the Loe and Silness (1963) criteria

  2. Gingival Index (GI)

    Time frame: Baseline and 6 months post-surgery

    Assessed using the Loe and Silness (1963) criteria to evaluate gingival inflammation

  3. Vertical Clinical Attachment Level (VCAL)

    Time frame: Baseline and 6 months post-surgery

    Measured using a UNC-15 periodontal probe and a customized acrylic stent

  4. Gingival Recession (GR)

    Time frame: Baseline, 3 months, and 6 months post-surgery

    Evaluated using a 3D intraoral scanner (3Shape TRIOS) and a customized acrylic stent

  5. Radiographic Vertical Bone Level (VBL)

    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

  6. Furcation Defect Volume

    Time frame: Baseline and 6 months post-surgery

    Evaluated using CBCT images and 3D segmentation software (ITK-SNAP)

  7. New Bone Gray Level

    Time frame: Baseline and 6 months post-surgery

    Evaluated using CBCT and ImageJ software to assess the density of newly formed bone

  8. TWEAK Biomarker Concentration

    Time frame: Baseline, 1 month, and 3 months post-surgery

    Measured in Gingival Crevicular Fluid (GCF) using Enzyme-Linked Immunosorbent Assay (ELISA)

  9. Post-operative Pain Perception

    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"

  10. Post-operative Painkiller Consumption

    Time frame: Up to 3 days post-surgery

    Recorded as the total number of analgesic tablets consumed by the patient

  11. Post-operative Patient Satisfaction

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Thanh Si Ho, Doctor of Dental Surgery

CONTACT

[email protected]

+84944510521

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Efficacy of Platelet-Rich Fibrin Combined With Xenograft in the Treatment of Mandibular Molar Furcation Involvements

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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