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NCT Number: NCT03853200

Comparison of Antibacterial Efficacy of Three Final Irrigants

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.

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Root Canal Infection Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hasan Zaidi

Karachi, Sindh, 75055, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QMix Root Canal Irrigant

Drug

Endodontic irrigant recommended for final irrigation

Other names: QMIx

17%EDTA+2%Chlorhexidine

Drug

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

Other names: EDTA, Chlorhexidine

EDTA

Other

17% EDTA irrigation solution

Other names: Ethylenediaminetetra acetic acid

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 25, 2019
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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