A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percentage of Root Coverage
研究概览
简要总结
Different surgical techniques have been proposed for root coverage, showing varying results especially in areas of deep recessions. The aim of this study is to evaluate the effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller class I or II deep recessions, requiring regeneration of lost periodontal tissues. Sample should be comprised of patients aged 18-45 years, both genders, presenting at least one site with marginal tissue recession >4mm. Patients will be randomly assigned to either one of the groups, based on treatment technique: newly forming bone (NFB) or subepithelial connective tissue graft (SCTG). Clinical examinations will be performed by a single blinded examiner at baseline, 1, 3, 6 and 9 months after surgery. Intra-group analysis will be performed by one way analysis of variance for repeated measures. Inter-group analysis will be performed by unpaired t-test for each of evaluation periods.
详细描述
Both gender patients presenting Miller class I or II recession defects >4mm were selected. Patients were randomly assigned to treatment groups: newly forming bone graft (NFBG) or subepithelial connective tissue graft (SCT). Patients were treated in the period of February 2008 and March 2008 and monitored during 9 months.
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 (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
- 是
入选标准
- •Healthy adults with at least one tooth presenting marginal tissue recession equal to or greater than 4mm in depth and one edentulous area or tooth to be extracted.
排除标准
- •Pregnants
- •Use of anti-convulsants, anti-hypertensives, cyclosporine or hormones
- •Use of antibiotics for the last 6 months
- •Patients under treatment for medical conditions or presenting systemic disorders that would impair treatment results (e.g.: uncontrolled diabetes mellitus)
研究组 & 干预措施
Newly forming bone
Miller class I or II deep recessions treated by the newly forming bone technique.
干预措施: Newly forming bone technique for root coverage (Procedure)
Subepithelial connective tissue graft
Miller class I or II deep recessions treated by subepithelial connective tissue graft.
干预措施: Subepithelial connective tissue graft for root coverage. (Other)
结局指标
主要结局
Percentage of Root Coverage
时间窗: Baseline, 9 months post-operatively
Percentage of root coverage determined by: \[area covered\]/\[total area to be covered\] x 100 (in %)
次要结局
- Gain of Clinical Attachment Level(9 months post-operatively)
研究者
Adriana Campos Passanezi SantAna
Associate Professor
University of Sao Paulo