Effectiveness of Autologous Injectable Platelet Rich Fibrin and Hyaluronic Acid for the Treatment of Interdental Papillary Loss (Black Triangle) in the Manipuri Population.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Primary outcome is to check the effectiveness of autologous i- PRF with and without commercially available hyaluronic acid (HA) for the treatment of interdental papillary loss (Black Triangle).
研究概览
简要总结
Introduction
The present study will be conducted to check the effectiveness of autologous i- PRF with and without commercially available hyaluronic acid (HA) for the treatment of interdental papillary loss (Black Triangle).
Material and Methods
The patients attending the Out- Patient Department of a Dental College will be enrolled in the study as per the inclusion and exclusion criteria.
Inclusion criteria
1. 1. Patients 18 years or more with interdental papilla loss with radiographic evidence of bone loss such that the distance from apical end of contact point to the crest of alveolar bone is <= 7mm in the anterior region.
2. 2. Teeth in proper alignment in the arch with normal contact point
3. 3. Teeth with Class II Recession (Kumar and Masamatti classification, 2013)28: The tip of the interdental papilla is located between the interdental contact point and the level of the CEJ mid-buccally/mid-lingually. Interproximal bone loss is visible on the radiograph.
- Patients with GI and PI score <1 after phase 1 therapy.
Exclusion criteria
1. Patients with missing teeth in the arch
2. Patients who have undergone any other periodontal treatment in the anterior region in the last 6 months
3. Patients with habits associated with tobacco’
4. Patients who are pregnant, on any form of medication affecting the gingival health
- Patients who are medically compromisedFollowing this, the interdental papilla in the anterior region will be evaluated and two areas with black triangles will be selected. Further, the two areas selected will be divided into experimental site A and experimental site B by the way of tossing a coin.
1. Experimental site A- Interdental papilla loss treated with autologous i-PRF alone.
2. Experimental site B- Interdental papilla loss treated with combination of i-PRF and commercially available HA.
The sites will be evaluated clinically and radiographically at 1 month, 3 months, 6 months and 9 months.
The statistical analysis of the data will be done at the end of the study
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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
- •Patients with interdental papilla loss with radiographic bone loss upto seven mm from apical end of contact point.
- •Teeth in proper alignment in the arch with normal contact point.
- •teeth with class two recession where the tip of interdental papilla is located between the interdental contact point and the level of the CEJ mid bucally or mid lingually.
- •kumar and masamatti classification
- •Interproximal bone loss is visible on the radiograph.
- •Patients with GI and PI score less than on eaafter phase one therapy.
排除标准
- •1.Patients with missing teeth in the arch.
- •2.Patients who have undergone any other periodontal treatment in the anterior region in the last 6 months 3.Patients with habits associated with tobacco.
- •4.Patients who are pregnant, on any form of medication affecting the gingival health 5.Patients who are medically compromised.
结局指标
主要结局
Primary outcome is to check the effectiveness of autologous i- PRF with and without commercially available hyaluronic acid (HA) for the treatment of interdental papillary loss (Black Triangle).
时间窗: 0 month | 9 months
次要结局
- 1.To check the effectiveness of autologous i-PRF in the treatment of black triangles.(2.To assess the effectiveness of I-PRF in combination with commercially available Hyaluronic acid (HA) in the treatment of black triangles.)
研究者
Tanya Nandkeoliar
Dept of Periodontology, Dental College, RIMS