Comparison of Antibacterial Efficacy of Three Final Irrigants

Study Overview
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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.

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

Conditions
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Endodontic Disease, Root Canal Infection

Intervention / Treatment
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* Drug: QMix Root Canal Irrigant
* Drug: 17%EDTA+2%Chlorhexidine
* Other: EDTA


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Colony forming Unit | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Final irrigation, Irrigation in Endodontics, QMix, CFU, Colony forming unit, MRS, Microbiological root canal sampling