Comparison of Antibacterial Efficacy of Three Final Irrigants

February 22, 2019 updated by: Hasan Afaq Zaidi, Dow University of Health Sciences

In-vivo Comparison of Antibacterial Efficacy of Three Different Solutions as Final Irrigant During Endodontic Therapy: A Randomized Controlled Trial

This study was conducted to determine the antibacterial affect of three different solutions used as final irrigant during endodontic therapy. The investigator's objective was to compare the antibacterial affect of relatively new final irrigant QMix with EDTA and Qmix with EDTA+CHX by evaluating the bacteriological status of the root canal before and after use of the final irrigant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this clinical trial is to compare the antibacterial efficacy of Qmix, to 17% EDTA+ Chlorhexidine and 17% EDTA, used as final irrigants, during endodontic procedure.

Endodontic treatment was carried out on 90 necrosed teeth of patients under rubber dam isolation and strict sterilization protocol. The teeth were divided into three groups; A, B and C depending on the type of final irrigant to be used. The chemo-mechanical preparation of all the 90 samples was carried out using ProTaper Universal (Dentsply) File system, and 3% sodium Hypochlorite. All the samples from each group were then irrigated according to the final rinse protocol (FRP). Group A was irrigated with Qmix; Group B with 17% EDTA + 2% Chlorhexidine and Group C (Control group) 17% EDTA.

Three bacteriologic samples were taken during the procedure from each root canal under study in all three groups, using sterile paper points. Sample A was collected after access cavity opening and negotiation of the canal but before chemo-mechanical preparation. Sample B was taken after chemo-mechanical preparation but before the use of the final irrigant. Sample C was collected after the use of final irrigation solution. The samples were collected with sterile paper points and were then transferred to microbiology laboratory in microtubes containing Brain Heart Infusion (BHI) broth within 2 hours of sample collection for obtaining the colony forming unit (CFU) counts.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75055
        • Hasan Zaidi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Teeth:

    • Single rooted (One root canal)
    • Necrosed teeth requiring root canal treatment.
    • Teeth with mature apices
    • Permanent dentition
    • Mandibular & Maxillary
    • PAI category 1 to 4

Exclusion Criteria:

• Teeth:

  • Single rooted teeth with multiple canals
  • Root canal treated
  • Requiring elective endodontic therapy
  • With partial necrosis
  • Fractured
  • Having calcified and obliterated canals.
  • Having root resorption
  • Root canals which could not be negotiated to full working length with #10 K file
  • Having severe periodontitis with exacerbating features (PAI = 5)
  • Having grade III mobility
  • Patients who took systemic antibiotics in past four weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
QMix the solution under investigation which includes CHX EDTA and detergent QMix Root Canal Irrigant
Drug: QMix Root Canal Irrigant
Endodontic irrigant recommended for final irrigation
Other Names:
  • QMIx
Active Comparator: Group II
it involves use of two irrigant solutions, 17%EDTA+2%Chlorhexidine
Drug: 17%EDTA+2%Chlorhexidine
two endodontic irrigants will be used in this group in a sequential manner
Other Names:
  • Chlorhexidine
  • EDTA
Active Comparator: Group III
17% EDTA with no antibacterial activity . the control group
Other: EDTA
17% EDTA irrigation solution
Other Names:
  • Ethylenediaminetetra acetic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Colony forming Unit
Time Frame: Before and after use of final irrigant, up to 5 minutes
Change in the Colony forming unit (CFU) of the root canal sample will be assessed by determining the difference between Mean CFU of sample taken before use of final irrigant and sample taken after use of final irrigant.
Before and after use of final irrigant, up to 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Hasan Zaidi, BDS, Dow University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2017

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

February 22, 2019

First Posted (Actual)

February 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-796/DUHS/Approval/2016/324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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