About this trial
This study consists of two components evaluating furcation involvement in mandibular molars among Stage III or Stage IV periodontitis patients. Component 1 is a cross-sectional study evaluating the prevalence and morphological characteristics of Hamp Class II furcation defects during initial screening. Component 2 is a randomized controlled clinical trial in 30 selected patients comparing the diagnostic accuracy of Cone Beam Computed Tomography (CBCT) against direct intra-operative clinical measurements, as well as evaluating the clinical and radiographic outcomes of regenerative periodontal surgery using Acellular Dermal Matrix (ADM) + Enamel Matrix Derivative (EMD) + Xenograft versus Autogenous Connective Tissue Graft (CTG) + EMD + Xenograft.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older who signed the informed consent form.
Diagnosed with Stage III or Stage IV periodontitis according to the 2017 AAP/EFP classification.
Completed non-surgical periodontal therapy with full-mouth plaque score (FMPS) and bleeding on probing (FMBS) <= 20%.
Presence of at least one mandibular molar with Hamp Class II furcation involvement (horizontal bone loss > 3 mm without through-and-through communication).
Disqualifiers
Uncontrolled systemic diseases (e.g., uncontrolled diabetes, hypertension, cardiovascular disease, severe osteoporosis).
Pregnant or lactating women.
Current smokers or individuals who quit smoking less than 6 months prior to enrollment.
Use of antibiotics, anti-inflammatory agents, or medications affecting bone metabolism (e.g., bisphosphonates, high-dose corticosteroids, anti-resorptive drugs) within the past 3 months.
Trial design
Parallel
Treatments tested in this trial
Acellular Dermal Matrix + EMD + Xenograft
Procedure/SurgerySurgical debridement of furcation defect, application of Enamel Matrix Derivative (EMD), placement of xenograft, and coverage with Acellular Dermal Matrix (ADM).
Autogenous Connective Tissue Graft + EMD + Xenograft
Procedure/SurgerySurgical debridement of furcation defect, harvesting autogenous connective tissue graft from the palate, application of Enamel Matrix Derivative (EMD), placement of xenograft, and coverage with CTG.
Treatment groups
Trial outcomes
Primary outcomes
Change in Probing Pocket Depth (PPD)
Reduction in probing pocket depth measured in millimeters (mm) at the furcation defect site from the gingival margin to the bottom of the pocket using a UNC-15 probe.
Change in Clinical Attachment Level (CAL)
Gain in clinical attachment level measured in millimeters (mm) at the furcation defect site from the cementoenamel junction (CEJ).
Prevalence and Morphological Distribution of Furcation Involvement
Prevalence of furcation defects in mandibular molars among Stage III/IV periodontitis patients and classification of defect severity according to Hamp's classification (Class I, II, and III).
Secondary outcomes
Change in Radiographic Vertical Bone Level on CBCT (CEJ-B)
Change in vertical distance from the cementoenamel junction to the base of the bone defect (CEJ-B) measured in millimeters (mm) on CBCT scans.
Change in Radiographic Horizontal Bone Loss on CBCT (H-BL)
Reduction in horizontal bone loss (H-BL) depth in the furcation area measured in millimeters (mm) on cross-sectional CBCT images.
Change in Gingival Recession (GR)
Comparison of furcation defect dimensions (in mm) measured on pre-operative CBCT scans against direct clinical measurements obtained during surgery using a K-file (#60) after open flap debridement.
Change in Gingival Thickness (GT)
Change in facial gingival thickness measured in millimeters (mm) using an endodontic file with a silicone stop and digital caliper.
Sponsors and contacts
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