Overview
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.
Description
This is a randomized controlled clinical trial involving patients with periodontitis who have Class II furcation defects affecting mandibular first and/or second molars. A total of 24 eligible teeth are planned, with 12 teeth assigned to each treatment group.
Before surgery, participants will undergo clinical periodontal examination, intraoral three-dimensional scanning, CBCT imaging, and gingival crevicular fluid collection. Clinical measurements include plaque index (PI), gingival index (GI), probing pocket depth (PPD), vertical clinical attachment loss (VCAL), and horizontal clinical attachment loss (HCAL).
Eligible defects will be randomly assigned to one of two regenerative surgical treatments. Following flap elevation, debridement, root surface cleaning, and conditioning with 24% EDTA, the control group will receive xenograft bone covered with a resorbable collagen membrane. The experimental group will receive enamel matrix derivative applied to the defect-related root surface, followed by xenograft bone combined with enamel matrix derivative. The flap will then be repositioned and sutured.
Postoperative pain will be assessed using a visual analog scale, together with analgesic consumption and patient-reported satisfaction regarding swelling and chewing ability. Participants will return for follow-up at approximately 2 weeks, 1 month, 3 months, and 6 months after surgery. Gingival crevicular fluid will be collected during follow-up for measurement of TWEAK concentration.
At 3 months, selected periodontal and biological assessments will be repeated. At 6 months, periodontal clinical measurements, intraoral three-dimensional scanning, furcation defect classification, and CBCT imaging will be repeated to evaluate changes in defect volume and relative bone density.
The primary purpose of the study is to compare the regenerative effectiveness of xenograft bone combined with enamel matrix derivative with that of xenograft bone combined with a collagen membrane for the treatment of mandibular molar Class II furcation defects.
Eligibility
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.
