Comparison of Root Coverage of Gingival Recessions Using Connective Tissue Graft and Collagen Matrix
试验速览
- 阶段
- 2 期
- 入组人数
- 46
- 主要终点
- gingival recession
研究概览
简要总结
The purpose of this study is to analyze the percentage of root coverage in Miller class I and II gingival recessions using connective tissue graft and collagen matrix with a two years follow-up.
详细描述
A sample calculation using a mean of 2.92 mm of the quantity of keratinized mucosa obtained after six months in the most recent study (McGUIRE; SCHEYER, 2014) using the same collagen matrix with a standard deviation of ± 0.88 mm, a difference of 0.4 mm being chosen as statistically significant. In addition, a 95% bilateral confidence interval and 80% power were used. A sample of 38 individuals per group was obtained. In addition, a 20% loss is expected during follow-up, a total of 46 individuals should be evaluated.
Periapical radiographic examinations should be performed before the collection of data to confirm the absence of bone loss. The following clinical parameters should be evaluated in both test and control groups: visible plaque index, gingival bleeding index, gingival recession, keratinized mucosa width and thickness, probing depth, bleeding on probing and periodontal biotype for each teeth with a North Carolina periodontal probe. The periodontal biotype for each teeth should be rated as thin or thick, according to probe transparency during probing depth. For statistical purposes, percentages of faces with gingival recession should be calculated. These parameters should be evaluated at baseline and at one, three and six months, one and two years post-therapy.
Clinical parameters should be collected by two operators, calibrated by the Kappa test for the keratinized mucosa width and thickness, periodontal biotype, probing depth and gingival recession.
After the inclusion of the patients, anamnesis and initial examination were performed. The subjects should be divided randomly, using a simple draw, in the following two groups: test - (collagen matrix) and control - (connective tissue graft) placebo associated with basic periodontal therapy). The data should be analyzed using descriptive and inferential statistics, with parametric tests, through the software package Social Sciences (SPSS), version 17.0 (free version).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gingival recessions of class I or II types according to Miller (1985), in contralateral, superior or inferior premolars and / or canines;
- •Fine periodontal biotype characterized by the transparency of the North Carolina probe when introduced into the periodontal sulcus (KAN et al., 2003);
- •The teeth with gingival recession should not be restored in their cervical portion;
- •Periodontal health characterized by absence of bleeding at probing, depth of probing less than 3 mm;
- •Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%.
排除标准
- •Orthodontic appliances;
- •Fixed or removable prostheses involving the premolar teeth with gingival recession;
- •Being a smoker;
- •Pregnancy or lactation;
- •Systemic diseases that may interfere with healing or periodontal health (diabetes, leukemia, hypertension, among others).
研究组 & 干预措施
Test: collagen matrix
Root coverage using collagen matrix
干预措施: collagen matrix (Procedure)
Control: connective tissue graft
Root coverage using connective tissue graft
干预措施: connective tissue graft (Procedure)
结局指标
主要结局
gingival recession
时间窗: twenty-four months
gingival recession
时间窗: baseline
gingival recession
时间窗: three months
gingival recession
时间窗: six months
gingival recession
时间窗: twelve months
gingival recession
时间窗: eighteen months
次要结局
- Width of keratinized mucosa(baseline and three, six, twelve, eighteen and twenty-four months)
研究者
Karyna de Melo Menezes
Principal Invastigator
Universidade Federal do Rio Grande do Norte