EFFICACY AND COMPARATIVE EVALUTION OF INJECTABLE PLATELET RICH FIBRIN AND 2% HYALURONIC ACID GEL IN INTERDENTAL PAPILLA RECONSTRUCTION USING NON-SURGICAL APPROACH
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Papillary fill, Height of Interdental papilla (Nordland and Tarnow’s classification), Papillae Index Score (PIS) – (Nemcovsky’s classification), Clinical Measurement: CP-PT Distance (Distance from the Contact Point to Papillary Tip).
研究概览
简要总结
This study shall compare the effectiveness of Hyaluronic Acid Gel and Injectable Platelet Rich Fibrin for nonsurgical interdental papilla reconstruction in individuals with loss of interdental papilla. It will be conducted as a randomized, split mouth clinical trial involving 30 sites with loss of interdental papilla who meet the specified inclusion criteria. Various clinical parameters, including Papillary Fill, Height of Interdental Papilla (Norland and Tarnow’s Classification), Papilla Index Score (Nemcovsky’s classification), CP-PT Distance (Distance from the Contact Point to Papillary Tip), Gingival Index, Probing Depth, Verbal Analogue Scale for Pain and Discomfort, will be evaluated at baseline and over follow-up periods. The research aims to identify which material offers superior outcomes regarding Papillary Fill, and Healing. The findings will contribute to improving clinical decision making, providing dentists with evidence based recommendations for selecting the most suitable material. This research has the potential to advance interdental papilla reconstruction using nonsurgical approach by optimizing patient care, minimizing discomfort, and ensuring papillary fill for sites with interdental papilla loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subjects with both genders having age more than 18 years;
- •Patient complaint of food lodgment or esthetic consciousness for open gingival embrasure;
- •Presence of at least one site with Class 1 or Class 2 recession (according to Norland and Tarnow’s classification system) of the papilla in the maxillary and mandibular anterior region;
- •Patients having adequate zone of attached gingiva at the selected region; and
- •Patient having minimal probing depth (less than equal to 3 mm) at the deficient papillary sites.
排除标准
- •Teeth with caries, proximal restorations on the cervical (buccal or proximal) region, fixed prosthesis or orthodontic appliances;
- •Teeth with open contacts, interdental spacing, crowding, proclination, rotation, or alveolar bone loss;
- •Patients with active periodontal diseases and poor oral hygiene;
- •Patients having gingival recession on the labial surface of the teeth adjacent to the open embrasure;
- •Patients under orthodontic treatment or had orthodontic treatment in the past six months;
- •Patients with high frenum attachment;
- •Patients having bleeding disorders;
- •Patients with medical conditions that may affect periodontal healing or regeneration.
结局指标
主要结局
Papillary fill, Height of Interdental papilla (Nordland and Tarnow’s classification), Papillae Index Score (PIS) – (Nemcovsky’s classification), Clinical Measurement: CP-PT Distance (Distance from the Contact Point to Papillary Tip).
时间窗: Baseline, 1 month and 3 months
次要结局
- Gingival index, Probing depth, Verbal analogue scale for pain and discomfort(Baseline, 1 month and 3 months)
研究者
Dr Nisha Parikh
Dharmsinh Desai University