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Efficacy of Enamel Matrix Derivative Combined With Xenograft in the Treatment of Furcation Defects in Mandibular Molars

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Viet Nam
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
RECRUITING
Ho Chi Minh City
Time Frame
Start Date: 2026-06-29
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 24
Treatments
Experimental: Xenograft + Enamel Matrix Derivative
Active_comparator: Xenograft + Collagen Membrane
Related Therapeutic Areas
Sponsors
Leads: University of Medicine and Pharmacy at Ho Chi Minh City

This content was sourced from clinicaltrials.gov