Comparison of Antibacterial Efficacy of Three Final Irrigants

NCT ID: NCT03853200

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2018-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endodontic Disease Root Canal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group I

QMix the solution under investigation which includes CHX EDTA and detergent QMix Root Canal Irrigant

Group Type EXPERIMENTAL

QMix Root Canal Irrigant

Intervention Type DRUG

Endodontic irrigant recommended for final irrigation

Group II

it involves use of two irrigant solutions, 17%EDTA+2%Chlorhexidine

Group Type ACTIVE_COMPARATOR

17%EDTA+2%Chlorhexidine

Intervention Type DRUG

two endodontic irrigants will be used in this group in a sequential manner

Group III

17% EDTA with no antibacterial activity . the control group

Group Type ACTIVE_COMPARATOR

EDTA

Intervention Type OTHER

17% EDTA irrigation solution

Interventions

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QMix Root Canal Irrigant

Endodontic irrigant recommended for final irrigation

Intervention Type DRUG

17%EDTA+2%Chlorhexidine

two endodontic irrigants will be used in this group in a sequential manner

Intervention Type DRUG

EDTA

17% EDTA irrigation solution

Intervention Type OTHER

Other Intervention Names

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QMIx EDTA Chlorhexidine Ethylenediaminetetra acetic acid

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hasan Afaq Zaidi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hasan Zaidi, BDS

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

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Hasan Zaidi

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRB-796/DUHS/Approval/2016/324

Identifier Type: -

Identifier Source: org_study_id

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