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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acellular Dermal Matrix + EMD + Xenograft

    Procedure/Surgery

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

  • Autogenous Connective Tissue Graft + EMD + Xenograft

    Procedure/Surgery

    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.

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: ADM + EMD + XenograftExperimental treatment 1 intervention
Group B: CTG + EMD + XenograftActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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