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.
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.
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.
Parallel
Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative
Procedure/SurgeryPeriodontal 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/SurgeryPeriodontal 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.
Change in Probing Pocket Depth (PPD)
Probing pocket depth (PPD) is measured in millimeters from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at the mesiobuccal, buccal, and distobuccal sites of the treated tooth. Measurements are standardized using an individualized acrylic stent. The change in PPD from baseline to 6 months after surgery will be compared between the two treatment groups.
Change in Horizontal Clinical Attachment Loss (HCAL)
Horizontal clinical attachment loss (HCAL) is measured in millimeters from the buccal entrance of the furcation to the deepest horizontal point of the furcation defect using a Nabers periodontal probe and an individualized acrylic stent.
Change in Vertical Clinical Attachment Loss (VCAL)
Change in Buccal Gingival Recession (REC)
Change in Plaque Index (PI)
Change in Gingival Index (GI)
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