A comparative evaluation of vestibular incision subperiosteal tunnel access technique with platelet-rich fibrin vs amnion membrane in the treatment of gingival recession - A single-blinded parallel arm randomized clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Recession height
研究概览
简要总结
The study aims to compare the effectiveness of the minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique either with amnion membrane or platelet-rich fibrin (PRF) for the treatment of Cairo’s RT 1 gingival recession defects.
The primary objective of the study is to assess the change in aesthetic Root coverage which is done by measuring - Recession Height (RH), Recession Width (RW), and Pocket Probing depth (PPD) following treatment of Gingival recession by VISTA with PRF or Amnion membrane (AM).
The secondary objective is to assess the change in the following parameters following intervention for gingival recession:
1. Width of keratinized gingiva
2. Relative attachment level
3. Mean root coverage
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy patients with Cairos RT1 gingival recession on atleast 2 teeth and sufficient vestibular depth and attached gingiva.
排除标准
- •1.Patients with any systemic/compromising medical condition.
- •2.Patients with non-vital teeth.
- •3.Patients on immunosuppressant drugs, or drugs known to cause gingival enlargement.
- •4.Patients with active infections.
- •5.Patients with abnormal bleeding, clotting, prothrombin time 6.Patients having high frenal attachment.
- •7.Pregnant and lactating females.
结局指标
主要结局
Recession height
时间窗: Baseline | 1 month | 3 months | 6 months
Recession width
时间窗: Baseline | 1 month | 3 months | 6 months
Pocket probing depth
时间窗: Baseline | 1 month | 3 months | 6 months
次要结局
- Width of keratinized gingiva(Relative attachment level)