Efficacy of Connective Tissue Graft Wall Technique and Enamel Matrix Derivative in the Regenerative Treatment of Intrabony Periodontal Defects: A Prospective Clinical Study

Phạm Đình Thiên Khải1 个研究点分布在 1 个国家目标入组 17 人开始时间: 2024年6月1日最近更新: 2025年11月18日

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 17
试验地点: 1
主要终点: Clinical Attachment Level (CAL) Gain

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

This is a prospective, single-group interventional clinical trial conducted at the University of Medicine and Pharmacy at Ho Chi Minh City to evaluate the effectiveness of the connective tissue graft (CTG) wall technique combined with enamel matrix derivative (EMD, Emdogain®, Straumann) in the regenerative treatment of intrabony periodontal defects. The study included 17 patients diagnosed with stage III-IV periodontitis who presented with radiographically confirmed intrabony defects suitable for regenerative therapy.

All participants received treatment following a standardized periodontal surgical protocol. After local anesthesia, a split-thickness vestibular releasing flap was prepared to allow coronal advancement, with external reflection of the papilla at the defect site. Thorough degranulation and root surface debridement were performed using ultrasonic and hand instruments. The root surface was conditioned with 24% EDTA gel for 2 minutes, rinsed with saline, and then enamel matrix derivative was applied onto the root surface and into the defect. A palatal connective tissue graft harvested using the four-incision technique was de-epithelialized, trimmed to span the papillae, and sutured to the buccal flap to form a stable soft-tissue wall. The flap was coronally advanced and secured with horizontal mattress and interrupted sutures to achieve tension-free primary closure.

Clinical and radiographic outcomes are evaluated at multiple time points.

Clinical parameters: probing pocket depth (PPD) and clinical attachment level (CAL) at baseline, 3 months, and 6 months.

Soft-tissue and hygiene parameters: gingival recession (buccal and interproximal), gingival thickness, full-mouth plaque score (FMPS), and full-mouth bleeding score (FMBS) at baseline, 1, 3, and 6 months.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

盲法说明

Outcome assessors were blinded to the surgical intervention. Examiners responsible for clinical and radiographic measurements were not involved in the surgical procedures and were unaware of the treatment allocation, ensuring unbiased data collection

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adults ≥18 years old who can provide written informed consent.
•Diagnosis of stage III-IV periodontitis (2017 World Workshop).
•Completed initial non-surgical periodontal therapy with good plaque control.
•Full-mouth plaque score (FMPS) ≤20% and full-mouth bleeding score (FMBS) ≤20%.
•Presence of ≥1 intrabony periodontal defect with an intrabony component ≥3 mm, confirmed clinically and radiographically.
•Probing pocket depth (PPD) at the study site ≥6 mm.

排除标准

•Systemic conditions or medications that could affect periodontal healing (e.g., diabetes mellitus, immunodeficiency, bisphosphonates, corticosteroids, immunosuppressants).
•Current smokers or former heavy smokers.
•Pregnancy or lactation.
•Teeth with untreated endodontic lesions or non-vital status; furcation involvement class II-III.
•Untreated occlusal trauma or tooth mobility grade II-III.
•Third molars.