Endodontic DiseasePhase 2/3NCT03853200
Comparison of Antibacterial Efficacy of Three Final Irrigants
A Phase 2/3 study testing QMix Root Canal Irrigant, 17%EDTA+2%Chlorhexidine and EDTA in people with Endodontic Disease and Root Canal Infection, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Root Canal Infection
- What is being tested?
- QMix Root Canal Irrigant, 17%EDTA+2%Chlorhexidine and EDTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Apr 2017to 1 Feb 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Teeth:
- Single rooted teeth with multiple canals
- Root canal treated
- Requiring elective endodontic therapy
- With partial necrosis
- Fractured
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endodontic Disease, Root Canal Infection
- Being tested
- QMix Root Canal Irrigant, 17%EDTA+2%Chlorhexidine, EDTA
- Keywords
- Final irrigation, Irrigation in Endodontics, QMix, CFU, Colony forming unit, MRS, Microbiological root canal sampling
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QMix Root Canal IrrigantDrug
Also called QMIx
Endodontic irrigant recommended for final irrigation
17%EDTA+2%ChlorhexidineDrug
Also called EDTA, Chlorhexidine
two endodontic irrigants will be used in this group in a sequential manner
EDTAOther
Also called Ethylenediaminetetra acetic acid
17% EDTA irrigation solution
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | QMix the solution under investigation which includes CHX EDTA and detergent QMix Root Canal Irrigant Receives: Drug: QMix Root Canal Irrigant |
| Group II | Active comparator | it involves use of two irrigant solutions, 17%EDTA+2%Chlorhexidine Receives: Drug: 17%EDTA+2%Chlorhexidine |
| Group III | Active comparator | 17% EDTA with no antibacterial activity . the control group Receives: Other: EDTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after use of final irrigant, up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start3 Apr 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Afaq Zaidi, Dow University of Health Sciences
- Investigators
- Hasan Zaidi, BDS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853200
- Sponsor's protocol ID
- IRB-796/DUHS/Approval/2016/324
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vivo Comparison of Antibacterial Efficacy of Three Different Solutions as Final Irrigant During Endodontic Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03853200
- Acronym / sponsor ID
- IRB-796/DUHS/Approval/2016/324
- Conditions
- Endodontic Disease, Root Canal Infection
- Keywords
- Final irrigation, Irrigation in Endodontics, QMix, CFU, Colony forming unit, MRS, Microbiological root canal sampling
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: QMix Root Canal IrrigantQMix the solution under investigation which includes CHX EDTA and detergent QMix Root Canal Irrigant |
| Group II | Active comparator | Drug: 17%EDTA+2%Chlorhexidineit involves use of two irrigant solutions, 17%EDTA+2%Chlorhexidine |
| Group III | Active comparator | Other: EDTA17% EDTA with no antibacterial activity . the control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Teeth:
Key exclusion criteria (12 listed)
- Teeth:
- Single rooted teeth with multiple canals
- Root canal treated
- Requiring elective endodontic therapy
- With partial necrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QMix Root Canal IrrigantAlso: QMIxEndodontic irrigant recommended for final irrigation | Drug | Group I |
| 17%EDTA+2%ChlorhexidineAlso: EDTA, Chlorhexidinetwo endodontic irrigants will be used in this group in a sequential manner | Drug | Group II |
| EDTAAlso: Ethylenediaminetetra acetic acid17% EDTA irrigation solution | Other | Group III |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Zaidi, BDS principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing QMix Root Canal Irrigant, 17%EDTA+2%Chlorhexidine and EDTA in people with Endodontic Disease and Root Canal Infection, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Colony forming Unit (time frame: Before and after use of final irrigant, up to 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.