Evaluation of the efficacy of sticky bone and concentrated growth factor (CGF) membrane along with a coronally advanced flap (CAF) as compared to coronally advanced flap alone in the treatment of Millers class I and class II gingival recession defects.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in depth and width of Miller’s class I and class II gingival recession.
研究概览
简要总结
This is a clinical trial to determine the efficacy of sticky bone and concentrated growth factor (CGF) membrane along with a coronally advanced flap (CAF) as compared to coronally advanced flap alone in the treatment of Millers class I and class II gingival recession defects that will be conducted in Terna Dental College, India. The primary outcome will be to measure the depth and width of recession at 1, 3 and 6 months after surgery.
6 patients have been recruited for the trial as per inclusion criteria.
Case histories were taken and phase 1 therapy was performed on all subjects.
Impressions were taken and stents were prepared.
Routine blood investigations were done and informed consent was taken
Cornally advanced flap surgery was performed on the control site and coronally advanced flap with sticky bone and CGF membrane was performed on the test site.
Progress:
2 of 6 subjects have completed 6 months followup, clinical parameters were assessed.
4 of 6 subjects have completed 3 months followup, clinical parameters were assessed
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients with Millers class I and/or class II recession defects.
- •2 Patients between the age group of 18 – 60 yrs.
- •3 Patients maintaining good oral hygiene.
- •4 Systemically healthy patients.
- •6 Patients who do not consume tobacco in any form.
排除标准
- •1 Pregnant and lactating females.
- •2 Patients who have undergone any periodontal surgical therapy in the last 6 months in the same site.
- •3 Patients taking anticoagulants and anti-platelet drugs 4 Patients with allergies to materials used in treatment process.
结局指标
主要结局
Improvement in depth and width of Miller’s class I and class II gingival recession.
时间窗: baseline | 1 month | 3 month | 6 month
次要结局
- To measure and compare the improvement in relative attachment level, width of attached gingiva and gingival mucosal thickness in patients with Miller’s class I and class II gingival recessions, using coronally advanced flap alone or in combination with sticky bone and concentrated growth factor(baseline)