Ethanolic Extract of Sapindus Mukorossi as the Final Endodontic Irrigant.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- microleakage
研究概览
简要总结
The chief aim of root canal treatment is to reduce the microbial content and prevent further recontamination in the canal. Properly cleaned, shaped and obturated teeth will be having fewer chances of treatment failure. Every tooth has variable, complex canal anatomy consisting of ramifications and lateral canal. The instrumentation alone cannot reach all the areas for cleaning. For proper cleaning and removal of all microorganisms, the canal should be irrigated with any biocompatible, lubricant and antimicrobial agent. An irrigant should have a high compatibility factor, with canals, with obturating material and sealer. It should remove all the superficial barriers from canal tubules and allow sealer penetration, which aids in better adhesion and decreases the chances for recontamination.
Objectives: This study aims to compare the effect of experimental endodontic irrigant Sapindus mukorossi with 17% EDTA, on the microleakage, sealer penetration and interaction with sodium hypochlorite.
Ninety single-rooted teeth will be allocated into 2 experimental groups and a control group of 30 teeth each. The endodontic procedure will be done with protaper files. The sample in group 1 will be irrigated with 3.0% NaOCl after that by 17% EDTA and the sample in group 2 final irrigation will be given with Ethanolic extract of Sapindus mukorossi. After the preparation and final irrigation of all teeth, sterile saline will be used to flush all canals and dried using paper points. Obturation will be done with lateral condensation by gutta-percha. Teeth will be incubated at 37ºc and 100% humidity for 7 days. Varnish will be applied on the root surface except for apical 3mm. The teeth will be sectioned longitudinally and examined at 2 and 5mm from the root apex. The maximum depth of sealer penetration will be measured using a scanning electron microscope and microleakage will be tested through a dye penetration method under a stereomicroscope.
Testing of interaction between irrigant and hypochlorite will be done by placing 1ml irrigant with 1 ml sodium hypochlorite in a round bottom test tube and left for 1 week at 37ºc. An independent observer will look for precipitation formation or color changes
详细描述
Preparation of ethanolic extract of S.mukorossi:
The desiccated fruit of Sapindus mukorossi will be used for the formulation of an experimental root canal irrigant. The dry pericarps of s. mukorossi (≈ 1.0 kg) which is present around the seed nut, will be separated with a sharp blade. These pericarps will be blended to produce fine particles in a sterilized home blender (Enviro 3 in 1 juicer blender ENJ301). The resultant 10gram powder will be soaked in 100ml of absolute ethanol (99%) for 24hours at normal room temperature. This solvent will be filtered and removed with help of a rotary evaporator, and extract will be kept in cleaned screw-capped vials (Premium Vials B4702-12 Glass with Screw Cap) at -20º C until use. To form an operational concentration of 5 mg/ml, the extract will be re-dissolved in distilled water.
All samples were prepared by a single operator using the following protocol. After extraction tooth was stored in 0.1% thymol. Until further use. Specimens were randomly divided into 3 groups through computer-generated software. There will be 30 teeth in each group.
Chamber opening was done with # 4 diamond cutting round bur, a #10 K-type file (Maillefer/Dentsply) was introduced into each root canal till it could be seen outside the apical foramen. The working length will be decided by decreasing this length by 1mm. A single operator using K-type files (Maillefer/Dentsply) initially than with the ProTaper Universal System (Dentsply-Maillefer) up to F2 was performed. Irrigation was performed at each change of file with 2.5mL of 3% NaOCl (canasol). After instrumentation the sample Group 1 would be irrigated with 3ml of 17% EDTA and left in the canal for 1 minute. Group 2 will be irrigated with Sapindus mukorossi finally all groups will be flushed with 5ml of 0.9% normal saline. The control group's final irrigation was done with 0.9% saline.
Afterward, the specimen was dried with F2 sterile absorbent paper points and an F2 gutta-percha cone was selected as the master cone. Sealapex (Sybron-Endo, Glendora, CA, USA) sealer was mixed according to the manufacturer's instructions and placed in the canal via the help of a 25# k file.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Extracted single rooted teeth with mature apices. (carious/ non carious)
- •Teeth extracted for orthodontic and periodontal purpose.
- •Patient age between 18 to 40 years.
排除标准
- •Intracanal calcification. (will be assessed from pre-operative radiograph before extraction)
- •Root dilacerations.
- •Root caries, fracture or cracked.
- •Root resorption.
- •Previously treated or initiated root canal treatment.
研究组 & 干预措施
1. Ethylene diammine tetra acetic acid group
samples will be rinsed with ethylene diamine tetra acetic acid group, which is the gold standard for final rinse and compares with the experimental group.
干预措施: ethylene diamine tetra acetic acid (Drug)
3. Experimental group
final irrigation of root canal will be done with ethanolic extract of sapindus mukorossi
干预措施: ethanolic extract of sapindus mukorossi (Drug)
结局指标
主要结局
microleakage
时间窗: in a month
measured in milimeter by steriomicroscope
dentinal tubule penetration of selaer
时间窗: 2 months
measured in micrometer by scanning electron microscope
interaction of extract of sapindus mukorossi with hypochlorite
时间窗: in 4 weeks
precipitate formation visible with naked eye
次要结局
未报告次要终点
研究者
ARAIB TAHIR
MDS trainee operative dentistry
Dow University of Health Sciences