Mandibular molar furcation defects in advanced periodontitis: a regenerative treatment comparison

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project has two parts: a cross-sectional assessment to describe how common Hamp Class II furcation defects are in mandibular molars among Stage III/IV periodontitis patients, and a randomized controlled trial comparing two regenerative surgical approaches for these defects. One approach uses Acellular Dermal Matrix plus Enamel Matrix Derivative and xenograft, while the other uses autogenous connective tissue graft plus Enamel Matrix Derivative and xenograft. A key secondary aim is to compare diagnostic accuracy of CBCT versus direct intra-operative measurements at the time of surgery. Outcomes include clinical and radiographic measures at six months post-surgery to evaluate treatment effectiveness. The study is conducted at the Dental Clinic of the University of Medicine and Pharmacy at Ho Chi Minh City.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dental Clinic, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
  Ho Chi Minh City, Vietnam Recruiting

Study contacts

• Study coordinator: Nguyen Trung Hung, MSc, DDS
• Email: nthung.ncs.rhm25@ump.edu.vn
• Phone: +84 908248288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.