CTRI/2020/04/024868尚未招募不适用
coronally advanced flap with connective tissue graft or advanced platelet rich fibrin in the management of multiple gingival recession -A randomized controlled clinical trial
N DEEPA1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年5月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- mean root coverage, complete root coverage,
研究概览
简要总结
This is a prospective double blind parallel group randomized controlled trial done to compare the coronally advanced flap with connective tissue graft or advanced platelet rich fibrin in the management of multiple gingival recession. primary outcome variables will be to assess percentage of mean root coverage, complete root coverage using recesion esthetic score at 1,3 and 6 month follow-up. secondary outcome variable to assess gingival thickness at baseline, 1,3 and 6 month follow-up and assess patient centered outcomes visual analog scale and early wound healing index at 3 and 10 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 20-60 years Presence of more than one Miller class I or II buccal gingival recession defects.
- •(Miller 1985) No Medication known to interfere with periodontal tissue health / healing (steroids, Ca channel blockers, antiepileptic agents, immunosuppresants) •Absence of a history of previous periodontal surgery in the same site.
- •â€¢Non-smoker or former smoker.
排除标准
- •Current Smokers Patients with any systemic disorder known to interfere with periodontal treatment such as diabetes, coronary heart disease, Rheumatoid Arthritis, Rheumatic Fever, SLE, Malignancy, Respiratory diseases, Renal diseases, Other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.) •Presence of non carious cervical lesion.
- •â€¢Pregnant / Lactating mothers •Patients undergoing orthodontic treatment.
- •â€¢Presence of Malocclusion.
结局指标
主要结局
mean root coverage, complete root coverage,
时间窗: baseline, 1,3 and 6 months follow-up
次要结局
- gingival thickness, width of keratinized gingiva and patient centered outcomes(baseline, 1, 3 and 6 months follow-up)
研究者
研究点 (1)
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