An interventional study of Acellular Dermal Matrix + EMD + Xenograft and Autogenous Connective Tissue Graft + EMD + Xenograft in Periodontitis, Periodontitis (Stage 3) and Furcation Defects, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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.
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.
Target tooth requirements:
Exclusion Criteria:
Target teeth presenting with:
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
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, application of Enamel Matrix Derivative (EMD), placement of xenograft, and coverage with Acellular Dermal Matrix (ADM).
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.
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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline (Screening Phase)
Change in Radiographic Vertical Bone Level on CBCT (CEJ-B)
Change in vertical distance from the cementoenamel junction to the base of the bone defect (CEJ-B) measured in millimeters (mm) on CBCT scans.
Time frame: Baseline and 6 months post-operatively
Change in Radiographic Horizontal Bone Loss on CBCT (H-BL)
Reduction in horizontal bone loss (H-BL) depth in the furcation area measured in millimeters (mm) on cross-sectional CBCT images.
Time frame: Baseline and 6 months post-operatively
Change in Gingival Recession (GR)
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.
Time frame: Baseline, 1 month, 3 months, and 6 months post-operatively
Change in Gingival Thickness (GT)
Change in facial gingival thickness measured in millimeters (mm) using an endodontic file with a silicone stop and digital caliper.
Time frame: Baseline, 1 month, 3 months, and 6 months post-operatively
Change in Keratinized Tissue Height (KTH)
Change in keratinized tissue height measured from the gingival margin to the mucogingival junction in millimeters (mm) following 3% Lugol's iodine staining.
Time frame: Baseline, 1 month, 3 months, and 6 months post-operatively
Diagnostic Accuracy of CBCT Imaging Versus Direct Intra-operative Measurements
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.
Time frame: Intra-operatively during surgery (compared against pre-operative baseline CBCT)
Plan to share: No — 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.
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University of Medicine and Pharmacy at Ho Chi Minh City