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Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements

12 augusti 2026 uppdaterad av: Thanh Si Ho, University of Medicine and Pharmacy at Ho Chi Minh City

Efficacy of Platelet-Rich Fibrin Combined With Xenograft in the Treatment of 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

22

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Vietnam
    • Ho Chi Minh City (HCMC)
      • Ho Chi Minh City, Ho Chi Minh City (HCMC), Vietnam, 700000
        • Rekrytering
        • Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: A-PRF+ and Xenograft
Open flap debridement followed by the application of A-PRF+ mixed with xenograft (Cerabone), covered by an A-PRF+ membrane
Procedur: A-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
Andra namn:
  • Cerabone
  • Advanced Platelet-Rich Fibrin plus
  • A-PRF+
Aktiv komparator: Collagen Membrane and Xenograft
Open flap debridement followed by the application of xenograft (Cerabone) covered by a resorbable collagen membrane
Procedur: Collagen 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
Andra namn:
  • Cerabone
  • Kollagenmembran
  • Guided Tissue Regeneration
  • Bio-Gide

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Horizontal Clinical Attachment Level (HCAL)
Tidsram: 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
Baseline and 6 months post-surgery
Probing Pocket Depth (PPD)
Tidsram: 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
Baseline and 6 months post-surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Plaque Index (PlI)
Tidsram: Baseline, 3 months, and 6 months post-surgery
Assessed at 4 sites per tooth using the Loe and Silness (1963) criteria
Baseline, 3 months, and 6 months post-surgery
Gingival Index (GI)
Tidsram: Baseline and 6 months post-surgery
Assessed using the Loe and Silness (1963) criteria to evaluate gingival inflammation
Baseline and 6 months post-surgery
Vertical Clinical Attachment Level (VCAL)
Tidsram: Baseline and 6 months post-surgery
Measured using a UNC-15 periodontal probe and a customized acrylic stent
Baseline and 6 months post-surgery
Gingival Recession (GR)
Tidsram: Baseline, 3 months, and 6 months post-surgery
Evaluated using a 3D intraoral scanner (3Shape TRIOS) and a customized acrylic stent
Baseline, 3 months, and 6 months post-surgery
Radiographic Vertical Bone Level (VBL)
Tidsram: Baseline and 6 months post-surgery
Measured on Cone Beam Computed Tomography (CBCT) images from the furcation fornix to the base of the defect
Baseline and 6 months post-surgery
Furcation Defect Volume
Tidsram: Baseline and 6 months post-surgery
Evaluated using CBCT images and 3D segmentation software (ITK-SNAP)
Baseline and 6 months post-surgery
New Bone Gray Level
Tidsram: Baseline and 6 months post-surgery
Evaluated using CBCT and ImageJ software to assess the density of newly formed bone
Baseline and 6 months post-surgery
TWEAK Biomarker Concentration
Tidsram: Baseline, 1 month, and 3 months post-surgery
Measured in Gingival Crevicular Fluid (GCF) using Enzyme-Linked Immunosorbent Assay (ELISA)
Baseline, 1 month, and 3 months post-surgery
Post-operative Pain Perception
Tidsram: 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"
12 hours, 1 day, and 3 days post-surgery
Post-operative Painkiller Consumption
Tidsram: Up to 3 days post-surgery
Recorded as the total number of analgesic tablets consumed by the patient
Up to 3 days post-surgery
Post-operative Patient Satisfaction
Tidsram: 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
3 days and 7 days post-surgery

Samarbetspartners och utredare

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Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 juni 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

30 juni 2027

Studieregistreringsdatum

Först inskickad

9 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

9 augusti 2026

Första postat (Faktisk)

13 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 26410 - ĐHYD

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