NCT01814592Unknown2 期
Comparison of Two Bilaminar Techniques for Root Covering of Miller´s Recessions Class I and II: A Blind, Randomized Controlled Clinical Trial
Universidad El Bosque, Bogotá2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque"
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of total root coverage between two coronally positioned flap technique in Miller recession Class I and II, in patients attending at "Universidad El Bosque" dental school clinics.
详细描述
This is a blind, randomized controlled clinical trial.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class I and II Miller recessions showing a recession depth ≥ 2 mm.
- •Recessions isolated and / or maximum continuous two teeth.
- •Recessions in incisors, canines and premolars
- •Patients 20 to 60 years old.
排除标准
- •Systemic compromise, that contraindicates any periodontal surgical procedure.
- •Warfarin medication.
- •Uncontrolled diabetes mellitus with glycosylated hemoglobin ≥ 8
- •Chronic steroid therapy (dose of 7.5 mg/ day for more than 14 days)
- •HIV-AIDS infection with CD4 counts <
- •Immunosuppression.
- •Recessions molars not be taken into account in the study.
- •Patients who have used antibiotics one month prior to the surgical procedure.
- •Pregnancy.
- •Active smoker.
- •Patients with a history of periodontal surgery at the recession area that has taken place in the last three months.
- •Severe dental malposition, teeth rotation, versions teeth root coverage that contraindicates surgery.
- •Non carious cervical lesions or caries where is not visible the cemento- enamel junction (CEJ).
- •Active inflammation that contraindicates surgical procedure of the recession.
- •Active Orthodontics
结局指标
主要结局
Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque"
时间窗: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)
次要结局
- Assess the proportion of root coverage(one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days))
- Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures(one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days))
研究者
Sergio Iván Losada Amaya
Professor, DDS, specialist in periodontics and oral medicine
Universidad El Bosque, Bogotá
研究点 (2)
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