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RECRUITING Not applicable ClinicalTrials.gov

Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects

Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City • ClinicalTrials.gov ID: NCT07776756

Registry updated: 2026-08-20
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Description

This randomized controlled clinical trial aims to compare two regenerative surgical approaches for the treatment of mandibular molar Class II furcation defects in patients with periodontitis. Eligible furcation defects will be randomly assigned to receive either xenograft bone combined with enamel matrix derivative (EMD) or xenograft bone combined with a collagen membrane. Both approaches are used to support periodontal tissue regeneration. Participants will be followed for approximately 7 months. The study will evaluate postoperative pain and patient-reported satisfaction, periodontal clinical parameters, changes in furcation defect volume and relative bone density on cone-beam computed tomography (CBCT), and changes in gingival crevicular fluid TWEAK levels. Clinical and radiographic outcomes will be assessed before surgery and during follow-up, including at 3 and 6 months after surgery. The study is intended to determine whether xenograft bone combined with EMD provides clinical, radiographic, biological, and patient-reported outcomes comparable or superior to xenograft bone combined with a collagen membrane in the regenerative treatment of mandibular molar Class II furcation defects.

Interventions

  • Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative (Procedure)
    Periodontal regenerative surgery is performed using xenograft bone combined with enamel matrix derivative (EMD). After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, EMD is applied to the root surface associated with the furcation defect. The xenograft bone is mixed with EMD and placed to completely fill the defect. The flap is then repositioned and sutured.
  • Periodontal Regenerative Surgery With Xenograft and Collagen Membrane (Procedure)
    Periodontal regenerative surgery is performed using xenograft bone combined with a resorbable collagen membrane. After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, the xenograft bone is mixed with sterile saline and placed to completely fill the furcation defect. A trimmed resorbable collagen membrane is positioned to completely cover the defect and secured before flap repositioning and suturing.

Eligibility criteria

Inclusion Criteria: * Age 18 years or older. * Full-mouth plaque score (FMPS) ≤ 20%. * Full-mouth bleeding score (FMBS) ≤ 20%. * Willingness to participate in the study and provide informed consent. * Mandibular first and/or second molar with a buccal Class II furcation defect classified as subgroup A2 or B2. * Probing pocket depth (PPD) ≥ 5 mm at the eligible furcation site. * Keratinized gingival height ≥ 2 mm at the eligible site. * No gingival recession extending apically beyond the buccal furcation roof; the furcation entrance must not be clinically exposed above the gingival margin. Exclusion Criteria: * Systemic diseases or conditions that may affect periodontal treatment outcomes, including uncontrolled diabetes mellitus, heart disease requiring anticoagulant therapy, hematologic disorders, or immunodeficiency. * Pregnancy or breastfeeding. * Untreated endodontic pathology involving the study tooth. * Class III furcation involvement according to the Hamp classification. * Untreated occlusal trauma involving the study tooth. * Grade II tooth mobility that has not been stabilized by splinting, or Grade III tooth mobility according to the Miller classification. * Defective restorations at the surgical site, including overhanging, bulky, or poorly adapted restorations.

Conditions

Class II Furcation Defect

Locations

  • Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City, Binh Phu, Vietnam
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record