drugset / Trial / NCT05038059

Ethanolic Extract of Sapindus Mukorrossi as Final Endodontic Irrigant.

NCT05038059

Completed 90 enrolled Dow University of Health Sciences
RandomizedParallel-groupDouble-blindPrevention

Summary

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

Timeline

Start
2020-04-02
Primary completion
2021-06-03
Completion
2021-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sapindus mukorossi Unknown 5 mg/ml Other
Comparator ethylene diamine tetra acetic acid Unknown 3 ml Other
Comparator ethylene diamine tetra acetic acid Unknown 17 % Other