NCT07770256 Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment

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This trial targets 98 participants in total. It began in 2026-05-02 with a primary completion date of 2027-12.

Brief Summary

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

Inclusion Criteria: * 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). * Target tooth requirements: * Probing pocket depth (PPD) \>= 5 mm. * Clinical attachment loss (CAL) \>= 3 mm. * Tooth mobility \<= Grade I (Miller index). * Vital pulp or adequately filled root canal treatment without periapical radiolucency. * Gingival margin positioned coronal to the furcation entrance. * Intact tooth structure without root fractures or furcation caries. Exclusion Criteria: * 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. * Previous periodontal surgery at the evaluation site within the past 6 months. * Target teeth presenting with: * Miller Grade II or Grade III tooth mobility. * Severe bone destruction extending to the root apex. * Metallic restorations (metal crowns, amalgam fillings, or large metallic posts) causing significant scatter/artifacts on CBCT scans. * Fused roots or abnormal root anatomy.

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