Evaluation of Local Drug Delivery with Simvastatin incorporated hydrogel in treatment of periapical lesions: A Clinical Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Reduction in size of periapical lesion in maxillary anterior teeth after using simvastatin, calcium hydroxide as intra canal medicament
研究概览
简要总结
Patients fitting the inclusion criteria will be selected. Informed consent will be taken. Local anesthesia will be administered. The concerned teeth will be isolated using rubber dam. Access opening, working length, cleaning and shaping(till F3, F4 or F5) will be done for the concerned teeth. The irrigation protocol followed will be 3% sodium hypochlorite and 17% EDTA followed by saline as final rinse. The placement of simvastatin hydrogel or calcium hydroxide as an intra canal medicament will be done using a syringe through the teeth and a temporary restoration will be placed.
The patient will be recalled after 1 week for obturation followed by a permanent restoration using Glass ionomer cement.
1, 3 and 6 months follow up will be done.
For preparation of Simvastatin hydrogel- Pure simvastatin will be obtained. 1.2% Simvastatin hydrogel will be prepared by ,mixing it with poloxamer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient presenting with chronic apical periodontitis in the Maxillary Anterior teeth with periapical lesions as seen on the radiograph Patient provides informed consent.
排除标准
- •Unwilling patients Patients with obstructed canals Smokers and alcoholics Pregnant and lactating women Periodontally compromised teeth Patients with bleeding disorders Patients who have an allergy to Simvastatin Patients on oral Simvastatin.
结局指标
主要结局
Reduction in size of periapical lesion in maxillary anterior teeth after using simvastatin, calcium hydroxide as intra canal medicament
时间窗: 1 month | 3 months | 6 months
次要结局
- Effectiveness of simvastatin hydrogel as an intra canal medicament(1 month)
研究者
Gaurav Sharma
Army College of Dental Sciences