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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03853200
Other study ID # IRB-796/DUHS/Approval/2016/324
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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