Clinical Evaluation of Interdental Papilla Reconstruction Using Injectable Autogenous Fat Compared To Hyaluronic Acid In Patients With Interdental Papillary Deficiency: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- change in Black Triangle Height (BTH)
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the amount of interdental papilla fill following the injection of the fat graft compared to hyaluronic acid filler in patients with interdental papilla deficiency. Highly motivated patients having at least one deficient papilla with the presence of a contact point between adjacent teeth in the inter-bicuspid region. Papillary deficiency types I or II, according to Nordland and Tarnow (1998)classification will be selected. The main question it aims to answer is: In patient with interdental papillary deficiency, will injecting autogenous fat increase papilla height compared to hyaluronic acid injection? Participants in the test group will receive fat graft injection in the inter dental papilla. In the injection phase, 3 injections will be given at each papilla site: at baseline, 3 and 6 weeks intervals. While in the control group, hyaluronic acid injection in the interdental papilla and also 3 injections will be given at each papilla site at the same intervals.
详细描述
The treatment protocol will be divided into 3 phases: the pre-operative phase, where patients will be examined for eligibility, the treatment phase, where both control and interventional treatments will be carried out and finally the follow up phase, where patients will be followed up for the duration of the study.
A- Preoperative Evaluation A.1. Medical History A thorough detailed personal and dental history will be collected from all patients. Medical evaluation will be done before enrolling patients in the study to exclude the presence of any disease that may contraindicate treatment or exclude the patient from the study.
A.2. Clinical evaluation Initial periodontal therapy including full mouth supragingival scaling and subgingival debridement and patient motivation and education for proper oral hygiene.
After 6 weeks, re-evaluation of the deficient papilla will be done, and the degree of papillary deficiency according to Nordland and Tarnow classification [13] will be determined. Plaque and gingival indices will also be assessed and used to determine eligibility. Only patients with deficient papilla fulfilling the inclusion criteria will be recalled discussing all treatment options and sign the informed consent.
Once enrolled in the study, alginate impression will be taken for the involved arch/arches to construct study casts and fabricate customized stents to standardize measurements throughout the study. Standardized digital clinical photographs will also be taken for the GBT as a baseline measurement of the dimension of the black triangle. One-week later patients will be scheduled for the 1st injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Highly motivated patients having at least one deficient papilla in the inter-bicuspid region.
- •Papillary deficiency types I or II, according to Nordland and Tarnow classification [13]
- •No radiographic evidence of bone loss interproximally. (Cardaropoli et al,2004)
- •Full mouth plaque index (PI) and gingival index (GI) scores should be less than 20%.
- •No open contacts between affected teeth should be present.
- •Teeth free from caries, proximal restorations, fixed prosthesis or orthodontic appliances
排除标准
- •Subjects with medical conditions that may affect periodontal healing or regeneration.
- •Subjects with a history of allergic reactions, smokers, and alcoholics
- •Pregnant or breastfeeding females
- •Patients with current or previous drugs intake that may predispose to gingival enlargement.
- •Patients under orthodontic treatment or had orthodontic treatment in the past six months
- •Patients with a history of periodontal surgeries over the last six months at the area of interest
结局指标
主要结局
change in Black Triangle Height (BTH)
时间窗: Specific measurement time point: at baseline and after 6 months postoperatively.
• The black triangle height (BTH) will be assessed using standardized digital clinical photographs and analyzed by an image analysis program (Photoshop Cs 5, Adobe Systems, San Jose, CA, USA).
次要结局
- change in Black triangle width(Specific measurement time point: at baseline and after 6 months postoperatively.)
- Post-operative pain(will be measured at 24 hours.)
- change in Black triangle area(Specific measurement time point: at baseline and after 6 months postoperatively.)
- Post-Surgical Patient Satisfaction:(will be measured after 1 week)
研究者
Mohamed Gamal El Din Abd El Salam
Assistant lecturer
Cairo University