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

NCT07770256

RecruitingNA

Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Conditions: Periodontitis, Periodontitis (Stage 3), Furcation Defects

Interventions: Acellular Dermal Matrix + EMD + Xenograft, Autogenous Connective Tissue Graft + EMD + Xenograft

Countries: Vietnam

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (1)
  • Ho Chi Minh City, Vietnam