Furcation Defects, Periodontitis, Periodontitis (Stage 3)
Conditions
Keywords
Periodontal Regeneration, Connective Tissue Graft, Enamel Matrix Derivative, Acellular Dermal Matrix, Cone-Beam Computed Tomography
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.
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.
Interventions
PROCEDUREAcellular 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).
PROCEDUREAutogenous 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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | 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. |
| Change in Clinical Attachment Level (CAL) | 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). |
| Prevalence and Morphological Distribution of Furcation Involvement | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Radiographic Vertical Bone Level on CBCT (CEJ-B) | 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. |
| Change in Radiographic Horizontal Bone Loss on CBCT (H-BL) | 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. |
| Change in Gingival Recession (GR) | 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. |
| Change in Gingival Thickness (GT) | 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. |
| Change in Keratinized Tissue Height (KTH) | 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. |
| Diagnostic Accuracy of CBCT Imaging Versus Direct Intra-operative Measurements | 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. |
Countries
Vietnam
Contacts
CONTACTNguyen Trung Hung, MSc, DDS
CONTACTNga Tran Yen, PhD, DDS
Outcome results
None listed