Ethanolic Extract of Sapindus Mukorrossi as Final Endodontic Irrigant.

NCT05038059 | Completed

• 1 other identifier: A_tahir
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Irreversible Pulpitis; Apical Periodontitis; Root Canal Infection

Outcome Measures

Primary Outcomes (3)

• microleakage

  measured in milimeter by steriomicroscope

  in a month

• dentinal tubule penetration of selaer

  measured in micrometer by scanning electron microscope

  2 months

• interaction of extract of sapindus mukorossi with hypochlorite

  precipitate formation visible with naked eye

  in 4 weeks

Study Arms (3)

1. Ethylene diammine tetra acetic acid group

ACTIVE COMPARATOR

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.

Drug: ethylene diamine tetra acetic acid

2. Control group

NO INTERVENTION

no final irrigant will be used and evaluate the outcomes

3. Experimental group

EXPERIMENTAL

final irrigation of root canal will be done with ethanolic extract of sapindus mukorossi

Drug: ethanolic extract of sapindus mukorossi

Interventions

ethanolic extract of sapindus mukorossi DRUG

ethanolic extract will be used as final endodontic irrigant during root canal procedures in extracted teeth.

Also known as: extract of soapnut

3. Experimental group

ethylene diamine tetra acetic acid DRUG

used as final endodontic irrigant in root canal therapy

Also known as: edta

1. Ethylene diammine tetra acetic acid group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Extracted single rooted teeth with mature apices. (carious/ non carious)
• Teeth extracted for orthodontic and periodontal purpose.
• Patient age between 18 to 40 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dr. Araib Tahir

Karachi, Sindh, Pakistan

Location

Related Publications (6)

• Thaha KA, Varma RL, Nair MG, Sam Joseph VG, Krishnan U. Interaction between Octenidine-based Solution and Sodium Hypochlorite: A Mass Spectroscopy, Proton Nuclear Magnetic Resonance, and Scanning Electron Microscopy-based Observational Study. J Endod. 2017 Jan;43(1):135-140. doi: 10.1016/j.joen.2016.09.015. Epub 2016 Dec 6.

  PMID: 27939737 BACKGROUND

• Pommel L, About I, Pashley D, Camps J. Apical leakage of four endodontic sealers. J Endod. 2003 Mar;29(3):208-10. doi: 10.1097/00004770-200303000-00011.

  PMID: 12669883 BACKGROUND

• Farhad AR, Barekatain B, Koushki AR. The Effect of Three Different Root Canal Irrigant Protocols for Removing Smear Layer on the Apical Microleakage of AH26 Sealer. Iran Endod J. 2008 Summer;3(3):62-7. Epub 2008 Jul 10.

  PMID: 24146672 BACKGROUND

• Violich DR, Chandler NP. The smear layer in endodontics - a review. Int Endod J. 2010 Jan;43(1):2-15. doi: 10.1111/j.1365-2591.2009.01627.x.

  PMID: 20002799 BACKGROUND

• Bloomfield SF, Miles GA. The antibacterial properties of sodium dichloroisocyanurate and sodium hypochlorite formulations. J Appl Bacteriol. 1979 Feb;46(1):65-73. doi: 10.1111/j.1365-2672.1979.tb02582.x. No abstract available.

  PMID: 35510 BACKGROUND

• Kuci A, Alacam T, Yavas O, Ergul-Ulger Z, Kayaoglu G. Sealer penetration into dentinal tubules in the presence or absence of smear layer: a confocal laser scanning microscopic study. J Endod. 2014 Oct;40(10):1627-31. doi: 10.1016/j.joen.2014.03.019. Epub 2014 May 10.

  PMID: 25260735 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Edetic Acid

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Araib AT Tahir, BDS

  dow university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDS trainee operative dentistry

Model Details: 3 groups assigned 2 with interventions and 1 control group.

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 8, 2021
• Study Start: April 2, 2020
• Primary Completion: June 3, 2021
• Study Completion: September 1, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

PA (1)