drugset / Trial / NCT07233733

A Clinical Study of Connective Tissue Graft and Enamel Matrix Derivative in the Treatment of Intrabony Periodontal Defects

NCT07233733

NaSingle-groupOpen-labelTreatment

Summary

This clinical study aims to evaluate the effectiveness of periodontal regenerative surgery using the connective tissue graft (CTG) wall technique combined with enamel matrix derivative (EMD) in patients who have intrabony periodontal defects. The purpose is to determine whether this combined approach can enhance both bone regeneration and soft-tissue stability compared with the patient's initial condition. Eligible participants will receive periodontal surgery in which a connective tissue graft and enamel matrix derivative are applied to the defect site. The study will monitor clinical improvements such as attachment gain, reduction in pocket depth, bone fill observed on cone-beam computed tomography (CBCT), and stability of the gingival margin and soft-tissue thickness. Clinical parameters (probing depth and attachment level) are recorded at baseline, 3 months, and 6 months. Gingival and hygiene parameters (recession, gingival thickness, plaque, and bleeding scores) are assessed at baseline, 1 month, 3 months, and 6 months. Radiographic bone outcomes are measured at baseline and 6 months, and early wound healing is assessed at 1 and 2 weeks. The main goal is to assess whether CTG + EMD treatment provides predictable periodontal regeneration, improved tissue stability, and better esthetic outcomes for patients with periodontitis.

Timeline

Start
2024-06-01
Primary completion
2025-03-01
Completion
2025-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject enamel matrix derivative Protein / enzyme biologic Topical
Background Amoxicillin Other / unclassified 875 mg Oral
Background Chlorhexidine Small molecule 0.12 % Oral
Background Clavulanate Unknown 125 mg Oral
Background EDTA Unknown 24 %
Background Ibuprofen Small molecule 400 mg Oral

Indications