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Clinical Trials/CTRI/2019/08/020553
CTRI/2019/08/020553CompletedPhase 1

Antimicrobial efficacy of commercially available ozonated olive oil and sodium hypochlorite with and without ultrasonic activation in primary endodontic infections- An vivo study

Garima1 site in 1 country56 target enrollmentStarted: May 8, 2019Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
56
Locations
1
Primary Endpoint
Microbial colonies

Study Overview

Brief Summary

The aim of thepresent study was to in- vivo evaluate the antimicrobial efficacy of commerciallyavailable ozonated olive oil with and without ultrasonic activation as rootcanal irrigant in primary endodontic infections and compare with conventionalirrigant i.e. 2.5% Sodium hypochlorite.

In the presentstudy, fifty six patients with single rooted teeth were selected. After local anaesthetic administration and rubberdam placement, access cavity was made. Working length was determined using an apexlocator and confirmed radiographically. Pretreatment sample (S1) was obtainedwith a paper point by injecting normal saline (5 ml) into the root canal andtransporting it into the peptone water. Biomechanical preparation was done upto the working length with master apical file size #40 and step back up to size#60.  The patients were randomly dividedinto four groups (n=14) - Group 1: 2.5% Sodium hypochlorite, Group 2: 2.5%Sodium hypochlorite with ultrasonic activation, Group 3 : Ozonated olive oiland Group 4: Ozonated olive oil with ultrasonic activation. Irrigation was donewith the respective irrigants during the biomechanical preparation and in Group2 and Group 4 irrigant was passively activated by ultrasonics. Postinstrumentation and irrigation sample (S2) was collected in the same manner asS1. Microbiological samples (S1, S2) were preincubated for 30 minutes andshaken vigorously in a vortex mixture for 60 seconds and then it was plated onBrain heart infusion agar and colonies were counted after 24 hours of incubationusing classic bacterial counting method.

The results ofthis study demonstrated that in intragroup comparison, statistically significantreduction was found from S1 to S2 in all the four experimental groups. Inintergroup comparison the mean reduction of bacterial counts of Group 1 (SodiumHypochlorite) and Group 3 (Ozonated olive oil) were found to be lower than thatof Group 2 (Sodium Hypochlorite with ultrasonic activation) and Group 4(Ozonated olive oil with ultrasonic activation). However, the difference wasnot statistically significant between Group 1 (Sodium Hypochlorite) and Group 3(Ozonated olive oil) but the difference was statistically significant betweenGroup 2 (Sodium Hypochlorite with ultrasonic activation) and Group 4 (Ozonatedolive oil with ultrasonic activation) with highest mean percentage bacterialreduction seen in Group 2 (Sodium Hypochlorite with ultrasonic activation).

Study Design

Study Type
Interventional
Allocation
Other
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
15.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients with non-contributory medical history, permanent teeth with necrotic or infected pulp as diagnosed clinically and radiographically with adequate coronal structure for proper isolation, temporization, and restoration will be included.

Exclusion Criteria

  • •Patients with systemic conditions, pregnant patients, acute periapical abscess, retreatment cases, patients on antibiotic therapy within three months, teeth with calcified canals, presence of intraoral or extraoral sinus, immature apex, internal and external resorption and periodontal pockets >5mm will be excluded.

Outcomes

Primary Outcomes

Microbial colonies

Time Frame: 24 hours of incubation

Secondary Outcomes

  • Microbial colonies count(after 24 hours)

Investigators

Sponsor
Garima
Sponsor Class
Other [(self)]

Study Sites (1)

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