Comparison of Antibacterial Efficacy of Three Final Irrigants

Endodontic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853200
• Other study ID #: IRB-796/DUHS/Approval/2016/324
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 3, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2019
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 status of the root canal before and after use of the final irrigant.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Root Canal Infection

Intervention

Drug:
• QMix Root Canal Irrigant
Endodontic irrigant recommended for final irrigation
• 17%EDTA+2%Chlorhexidine
two endodontic irrigants will be used in this group in a sequential manner

Other:
• EDTA
17% EDTA irrigation solution

Locations

Country	Name	City	State
Pakistan	Hasan Zaidi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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