Comparison of Antibacterial Efficacy of Three Final Irrigants
Primary Purpose
Endodontic Disease, Root Canal Infection
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
QMix Root Canal Irrigant
17%EDTA+2%Chlorhexidine
EDTA
Sponsored by
About this trial
This is an interventional treatment trial for Endodontic Disease focused on measuring Final irrigation, Irrigation in Endodontics, QMix, CFU, Colony forming unit, MRS, Microbiological root canal sampling
Eligibility Criteria
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.
Sites / Locations
- Hasan Zaidi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Group I
Group II
Group III
Arm Description
QMix the solution under investigation which includes CHX EDTA and detergent QMix Root Canal Irrigant
it involves use of two irrigant solutions, 17%EDTA+2%Chlorhexidine
17% EDTA with no antibacterial activity . the control group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03853200
First Posted
February 21, 2019
Last Updated
February 22, 2019
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03853200
Brief Title
Comparison of Antibacterial Efficacy of Three Final Irrigants
Official Title
In-vivo Comparison of Antibacterial Efficacy of Three Different Solutions as Final Irrigant During Endodontic Therapy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease, Root Canal Infection
Keywords
Final irrigation, Irrigation in Endodontics, QMix, CFU, Colony forming unit, MRS, Microbiological root canal sampling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
QMix the solution under investigation which includes CHX EDTA and detergent QMix Root Canal Irrigant
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
it involves use of two irrigant solutions, 17%EDTA+2%Chlorhexidine
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
17% EDTA with no antibacterial activity . the control group
Intervention Type
Drug
Intervention Name(s)
QMix Root Canal Irrigant
Other Intervention Name(s)
QMIx
Intervention Description
Endodontic irrigant recommended for final irrigation
Intervention Type
Drug
Intervention Name(s)
17%EDTA+2%Chlorhexidine
Other Intervention Name(s)
EDTA, Chlorhexidine
Intervention Description
two endodontic irrigants will be used in this group in a sequential manner
Intervention Type
Other
Intervention Name(s)
EDTA
Other Intervention Name(s)
Ethylenediaminetetra acetic acid
Intervention Description
17% EDTA irrigation solution
Primary Outcome Measure Information:
Title
Change in Colony forming Unit
Description
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.
Time Frame
Before and after use of final irrigant, up to 5 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Zaidi, BDS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Zaidi
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75055
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Antibacterial Efficacy of Three Final Irrigants
We'll reach out to this number within 24 hrs