Clinical Outcomes of Enamel Matrix Derivative and Connective Tissue Graft in Modified Coronally Advanced Tunnel: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Percentage of Root Surface Coverage (%RC)
研究概览
简要总结
This study investigates the treatment of gingival recession (specifically Miller Class I and II defects) using a minimally invasive surgical approach known as the modified coronally advanced tunnel (MCAT) technique. Participants are allocated into three groups: one receiving subepithelial connective tissue grafts (SCTG), another treated with enamel matrix derivatives (EMD), and a third group receiving a combination of SCTG and EMD.
The primary objective is to evaluate the clinical effectiveness of each treatment modality in terms of root coverage, esthetic outcomes, and postoperative patient comfort. The study also aims to determine whether the combined use of SCTG and EMD provides superior clinical results compared to their individual application. Both short-term and long-term treatment outcomes are assessed to identify the most effective approach for managing gingival recession.
详细描述
This randomized controlled clinical trial aims to evaluate both the short- and long-term clinical outcomes of the modified coronally advanced tunnel (MCAT) technique combined with various biomaterials in the treatment of Miller Class I and II gingival recession defects.
A total of 60 systemically healthy individuals, aged between 18 and 60 years, presenting to the Department of Periodontology at Necmettin Erbakan University Faculty of Dentistry with gingival recession complaints will be included. Prior to enrollment, all participants will undergo routine periodontal examinations and nonsurgical Phase I therapy. Standard mucogingival procedures are routinely performed at this institution.
Participants will be randomly assigned to one of the following three treatment groups (n=20 each):
Group 1: MCAT + subepithelial connective tissue graft (SCTG) Group 2: MCAT + enamel matrix derivative (EMD) Group 3: MCAT + SCTG + EMD Clinical Evaluations
Clinical assessments will be conducted at baseline, 3 months, and 6 months postoperatively and will include the following parameters:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 18 and 60 years
- •Systemically and periodontally healthy individuals
- •Non-smokers
- •Presence of a clearly detectable cementoenamel junction (CEJ)
- •No prior surgical intervention at the selected sites
- •No periodontal pockets deeper than 3 mm
- •No signs of occlusal trauma
排除标准
- •Pregnancy or lactation
- •Use of antibiotics in the past 6 months
- •Presence of any systemic condition that may contraindicate periodontal surgery, including:
- •Diabetes mellitus
- •Impaired glucose tolerance
- •Endocrine disorders
- •Cardiovascular diseases
- •Declined to participate or failed to meet inclusion criteria
结局指标
主要结局
Percentage of Root Surface Coverage (%RC)
时间窗: 6 months postoperatively
The percentage of root surface coverage will be calculated based on changes in the exposed root surface area before and after treatment. The exposed area is estimated by multiplying the height and width of the gingival recession. The difference between the baseline and 6-month postoperative values will be used to determine the percentage of coverage. Results will be expressed as a percentage (%). This approach reflects the clinical effectiveness of the intervention and is based on the method described by Al-Hamdan et al. (2003).
次要结局
- Gingival Index (GI)(Baseline, 1, 3, and 6 months postoperatively)
- Plaque Index (PI)(Baseline, 1, 3, and 6 months postoperatively.)
- Gingival Recession Height (GRH)(Baseline, 1, 3, and 6 months postoperatively)
- Gingival Recession Width (GRW)(Baseline, 1, 3, and 6 months postoperatively.)
- Clinical Attachment Level (CAL)(Baseline and 6 months postoperatively.)
- Keratinized Tissue Width (KTW)(Baseline, 1, 3, and 6 months postoperatively.)
- Gingival Thickness(Baseline and 6 months postoperatively.)
- Wound Healing Index (WHI)(2 weeks postoperatively.)
- Probing Depth (PD)(Baseline and 6 months postoperatively.)
研究者
Fatma Altıparmak
DDS, Research Assistant in the Department of Periodontology
Necmettin Erbakan University