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

August 14, 2026 updated by: Nguyen Trung Hung, University of Medicine and Pharmacy at Ho Chi Minh City

Morphological Characteristics of Furcation Involvement in Mandibular Molars and Efficacy of Regenerative Surgical Treatment: A Cross-Sectional and Interventional 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Objectives:Furcation involvement in multi-rooted teeth presents a significant challenge in periodontal therapy. Precise morphological diagnosis using 3D imaging (CBCT) and effective regenerative strategies are essential to improve tooth prognosis. This study aims to: Determine the prevalence and morphological characteristics of furcation defects in mandibular molars (Cross-sectional component). Compare the diagnostic accuracy of CBCT imaging with direct intra-operative clinical measurements obtained during surgical access (Interventional component). Evaluate and compare the clinical and radiographic efficacy of regenerative periodontal surgery using Acellular Dermal Matrix (ADM) combined with Enamel Matrix Derivative (EMD) and xenograft versus Autogenous Connective Tissue Graft (CTG) combined with EMD and xenograft in Hamp Class II furcation defects at 6 months post-operatively. Study Design and Workflow:Component 1 (Cross-Sectional Screening): Stage III/IV periodontitis patients presenting to the Dental Clinic at the Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City will be evaluated for the prevalence and morphological features of furcation defects. Component 2 (Randomized Controlled Trial): Following non-surgical periodontal therapy and re-evaluation, 30 patients with residual Hamp Class II furcation defects will be randomly assigned into two treatment groups: Experimental Group: Open flap debridement, placement of xenograft, Acellular Dermal Matrix (ADM), and Enamel Matrix Derivative (EMD). Active Comparator Group: Open flap debridement, placement of xenograft, Autogenous Connective Tissue Graft (CTG), and Enamel Matrix Derivative (EMD). Follow-up: Intra-operative clinical measurements will be compared with pre-operative CBCT scans. Clinical parameters (PPD, CAL) and radiographic bone fill (via CBCT) will be evaluated at baseline and 6 months post-operatively.

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nga Tran Yen, PhD, DDS

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Recruiting
        • Dental Clinic, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
        • Contact:
          • Dental University of Medicine and Pharmacy
          • Phone Number: +84 028 3855 8735
          • Email: khoarhm@ump.edu.vn
        • Principal Investigator:
          • Nguyen Trung Hung, MSc, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADM + EMD + Xenograft
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
Surgical debridement of furcation defect, application of Enamel Matrix Derivative (EMD), placement of xenograft, and coverage with Acellular Dermal Matrix (ADM).
Active Comparator: CTG + EMD + Xenograft
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth (PPD)
Time Frame: Baseline and 6 months post-operatively
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)
Time Frame: Baseline and 6 months post-operatively
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
Time Frame: Baseline (Screening Phase)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Radiographic Vertical Bone Level on CBCT (CEJ-B)
Time Frame: Baseline and 6 months post-operatively
Change in vertical distance from the cementoenamel junction to the base of the bone defect (CEJ-B) measured in millimeters (mm) on CBCT scans.
Baseline and 6 months post-operatively
Change in Radiographic Horizontal Bone Loss on CBCT (H-BL)
Time Frame: Baseline and 6 months post-operatively
Reduction in horizontal bone loss (H-BL) depth in the furcation area measured in millimeters (mm) on cross-sectional CBCT images.
Baseline and 6 months post-operatively
Change in Gingival Recession (GR)
Time Frame: Baseline, 1 month, 3 months, and 6 months post-operatively
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.
Baseline, 1 month, 3 months, and 6 months post-operatively
Change in Gingival Thickness (GT)
Time Frame: Baseline, 1 month, 3 months, and 6 months post-operatively
Change in facial gingival thickness measured in millimeters (mm) using an endodontic file with a silicone stop and digital caliper.
Baseline, 1 month, 3 months, and 6 months post-operatively
Change in Keratinized Tissue Height (KTH)
Time Frame: Baseline, 1 month, 3 months, and 6 months post-operatively
Change in keratinized tissue height measured from the gingival margin to the mucogingival junction in millimeters (mm) following 3% Lugol's iodine staining.
Baseline, 1 month, 3 months, and 6 months post-operatively
Diagnostic Accuracy of CBCT Imaging Versus Direct Intra-operative Measurements
Time Frame: Intra-operatively during surgery (compared against pre-operative baseline CBCT)
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.
Intra-operatively during surgery (compared against pre-operative baseline CBCT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 18, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26317 - ĐHYD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be made publicly available to protect participant privacy and confidentiality, in accordance with the protocol approved by the Ethics Committee. De-identified aggregate data and main findings will be published in the doctoral dissertation and peer-reviewed scientific journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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