Comparison of Antibacterial Efficacy of Three Final Irrigants

NCT03853200 | Completed Phase 2 FDA Drug

• 1 other identifier: IRB-796/DUHS/Approval/2016/324
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Disease; Root Canal Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group I

EXPERIMENTAL

QMix the solution under investigation which includes CHX EDTA and detergent QMix Root Canal Irrigant

Drug: QMix Root Canal Irrigant

Group II

ACTIVE COMPARATOR

it involves use of two irrigant solutions, 17%EDTA+2%Chlorhexidine

Drug: 17%EDTA+2%Chlorhexidine

Group III

ACTIVE COMPARATOR

17% EDTA with no antibacterial activity . the control group

Other: EDTA

Interventions

QMix Root Canal Irrigant DRUG

Endodontic irrigant recommended for final irrigation

Also known as: QMIx

Group I

17%EDTA+2%Chlorhexidine DRUG

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

Also known as: EDTA, Chlorhexidine

Group II

EDTA OTHER

17% EDTA irrigation solution

Also known as: Ethylenediaminetetra acetic acid

Group III

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Hasan Zaidi

Karachi, Sindh, 75055, Pakistan

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

QMix root canal irrigant; Edetic Acid; Chlorhexidine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Biguanides; Guanidines; Amidines

Study Officials

• Hasan Zaidi, BDS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: April 3, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

PA (1)