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

NCT07770256 | Recruiting DMC

• 1 other identifier: 26317 - ĐHYD
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Periodontitis (Stage 3); Furcation Defects

Keywords

Periodontal Regeneration; Connective Tissue Graft; Enamel Matrix Derivative; Acellular Dermal Matrix; Cone-Beam Computed Tomography

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and 6 months post-operatively

• 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).

  Baseline and 6 months post-operatively

• 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).

  Baseline (Screening Phase)

Secondary Outcomes (6)

• Change in Radiographic Vertical Bone Level on CBCT (CEJ-B)

  Baseline and 6 months post-operatively

• Change in Radiographic Horizontal Bone Loss on CBCT (H-BL)

  Baseline and 6 months post-operatively

• Change in Gingival Recession (GR)

  Baseline, 1 month, 3 months, and 6 months post-operatively

• Change in Gingival Thickness (GT)

  Baseline, 1 month, 3 months, and 6 months post-operatively

• Change in Keratinized Tissue Height (KTH)

  Baseline, 1 month, 3 months, and 6 months post-operatively

Study Arms (2)

ADM + EMD + Xenograft

EXPERIMENTAL

Patients with Hamp Class II furcation defects receive open flap debridement and regenerative periodontal surgery using Acellular Dermal Matrix (ADM) combined with Enamel Matrix Derivative (EMD) and xenograft.

Procedure: Acellular Dermal Matrix + EMD + Xenograft

CTG + EMD + Xenograft

ACTIVE COMPARATOR

Patients with Hamp Class II furcation defects receive open flap debridement and regenerative periodontal surgery using autogenous Connective Tissue Graft (CTG) combined with Enamel Matrix Derivative (EMD) and xenograft.

Procedure: Autogenous Connective Tissue Graft + EMD + Xenograft

Interventions

Acellular Dermal Matrix + EMD + Xenograft PROCEDURE

Surgical debridement of furcation defect, application of Enamel Matrix Derivative (EMD), placement of xenograft, and coverage with Acellular Dermal Matrix (ADM).

ADM + EMD + Xenograft

Autogenous Connective Tissue Graft + EMD + Xenograft PROCEDURE

Surgical 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.

CTG + EMD + Xenograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

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

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Periodontitis; Furcation Defects

Interventions

emerin; Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Central Study Contacts

Nguyen Trung Hung, MSc, DDS

CONTACT

+84 908248288; nthung.ncs.rhm25@ump.edu.vn

Nga Tran Yen, PhD, DDS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Faculty of Odonto-Stomatology

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 18, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)