Comparative evaluation of 2% injectable Hyaluronic acid versus i-PRF for reconstruction of lost interdental papilla : A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To assess the amount of papillary fill in the maxillary anterior region in the following groups of participants at the end of 3rd month,
研究概览
简要总结
The interdental papilla is the gingival area that occupies the interproximal zone below the contact point between two adjacent teeth. In addition to having a positive effect on smile aesthetics, interdental papillae are important in preventing food impaction between teeth and contribute to improved phonetics.A deficient interdental papilla is known as the black triangle which can result from several factors, e.g. the age of the subject, the shape/size of teeth, the length of the proximal contact point, and the interproximal gingival thickness.
Different treatment options are often proposed to close an open gingival embrasure, such as orthodontics or restorative, surgical and prosthetic care. However these methods are known to be invasive and unpredictable. Therefore minimally invasive techniques like 2% HA and i-PRF has been found to be effective and also most frequently used for the reconstruction of the lost interdental papilla.
As the HA and the i-PRF share similar properties in terms of promoting periodontal regeneration, collagen synthesis, and wound healing[7]. This study aimed to evaluate and compare the effectiveness of 2% injectable hyaluronic acid and i-PRF in the reconstruction of lost interdental papilla.
This study will include 14 systemically healthy participants, who meet the selection criteria ,reporting to the Department of Periodontology. Ethical clearance will be obtained and all the participants will b e subjected to oral prophylaxis before the study begins. The participants will be randomly allotted into one of the two study groups.
â–ª Group 1: For injectable 2% HA treatment protocol.
â–ª Group 2: For i-PRF protocol.
Clinical parameters such as (contact point to papillary tip [CP-PT] will be recorded using UNC 15 probe and standardized photographs taken for ImageJ software analysis) will be recorded at baseline, at the end of 1st and 3rd month , using these parameters the papillary fill will be evaluated.
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
- 19.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy participants.
- •2.Class I or class II papilla according to Nordland and Tarnow’s Classification system for loss of papillary height.
- •3.Loe and Silness gingival index less than or equal to 1.
排除标准
- •Participants using any form of tobacco.
- •Pregnant or lactating females.
- •Participants who are already on anti-inflammatory or anti-bacterial drugs.
- •Participants using a drug which has influence in gingival growth.
- •Participants with midline diastema / loss of proximal contact.
- •Participants with untreated maxillary anterior caries, prosthesis and orthodontic appliances.
结局指标
主要结局
To assess the amount of papillary fill in the maxillary anterior region in the following groups of participants at the end of 3rd month,
时间窗: Baseline, at the end of 1 month and at the end of 3rd month.
Group 1 with 2% Hyaluronic Acid
时间窗: Baseline, at the end of 1 month and at the end of 3rd month.
Group 2 with i-PRF.
时间窗: Baseline, at the end of 1 month and at the end of 3rd month.
次要结局
- To evaluate the effectiveness of injectable platelet-rich fibrin (i-PRF) in the reconstruction of lost interdental papilla.(At baseline, end of 1st and 3rd month)
- To compare the effectiveness of 2% HA and i-PRF in the reconstruction of lost interdental papilla.(At baseline, endo of 1st and 3rd month)