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Comparison of Antibacterial Efficacy of Three Final Irrigants

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03853200
Enrollment
90
Registered
2019-02-25
Start date
2017-04-03
Completion date
2018-02-01
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endodontic Disease, Root Canal Infection

Keywords

Final irrigation, Irrigation in Endodontics, QMix, CFU, Colony forming unit, MRS, Microbiological root canal sampling

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.

Interventions

DRUGQMix Root Canal Irrigant

Endodontic irrigant recommended for final irrigation

DRUG17%EDTA+2%Chlorhexidine

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

OTHEREDTA

17% EDTA irrigation solution

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Colony forming UnitBefore and after use of final irrigant, up to 5 minutesChange 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026