Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative
  • Periodontal Regenerative Surgery With Xenograft and Collagen Membrane

Treatment groups

24 Participants
are divided into 2 treatment groups