Comparison of Antibacterial Efficacy of Three Final Irrigants
NCT ID: NCT03853200
Last Updated: 2019-02-25
Study Results
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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COMPLETED
PHASE2/PHASE3
90 participants
INTERVENTIONAL
2017-04-03
2018-02-01
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group I
QMix the solution under investigation which includes CHX EDTA and detergent QMix Root Canal Irrigant
QMix Root Canal Irrigant
Endodontic irrigant recommended for final irrigation
Group II
it involves use of two irrigant solutions, 17%EDTA+2%Chlorhexidine
17%EDTA+2%Chlorhexidine
two endodontic irrigants will be used in this group in a sequential manner
Group III
17% EDTA with no antibacterial activity . the control group
EDTA
17% EDTA irrigation solution
Interventions
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QMix Root Canal Irrigant
Endodontic irrigant recommended for final irrigation
17%EDTA+2%Chlorhexidine
two endodontic irrigants will be used in this group in a sequential manner
EDTA
17% EDTA irrigation solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
Yes
Sponsors
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Dow University of Health Sciences
OTHER
Responsible Party
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Hasan Afaq Zaidi
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
Countries
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Other Identifiers
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IRB-796/DUHS/Approval/2016/324
Identifier Type: -
Identifier Source: org_study_id
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