Comparison of Antibacterial Efficacy of Three Final Irrigants

Dow University of Health Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Root Canal Infection; Endodontic Disease

Treatments: Drug: 17%EDTA+2%Chlorhexidine; Other: EDTA; Drug: QMix Root Canal Irrigant

Study type: Interventional

Funder types: Other

Identifiers

NCT03853200

IRB-796/DUHS/Approval/2016/324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Group I

Experimental group

Description:

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

Treatment:

Drug: QMix Root Canal Irrigant

Group II

Active Comparator group

Description:

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

Treatment:

Drug: 17%EDTA+2%Chlorhexidine

Group III

Active Comparator group

Description:

17% EDTA with no antibacterial activity . the control group

Treatment:

Other: EDTA