CTRI Number |
CTRI/2019/08/020553 [Registered on: 05/08/2019] Trial Registered Prospectively |
Last Modified On: |
27/07/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To compare and evaluate the efficacy of ozonated olive oil and sodium hypochlorite in killing root canal microorganisms. |
Scientific Title of Study
|
Antimicrobial efficacy of commercially available ozonated olive oil and sodium hypochlorite with and without ultrasonic activation in primary endodontic infections- An vivo study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Garima |
Designation |
Post Graduate student |
Affiliation |
Sudha rustagi college of dental sciences and research |
Address |
PG Section, Room No 7
Department of Conservative Dentistry and Endodontics
Sudha rustagi college of dental sciences and research
Sector-89 Kheri more
Faridabad HARYANA 121002 India |
Phone |
9711222414 |
Fax |
|
Email |
garimagk20@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rakesh Kumar |
Designation |
Professor and Head of Department of Conservative Dentistry and Endodontics |
Affiliation |
Sudha rustagi college of dental sciences and research |
Address |
Sector 89, Kheri More
Sudha Rustagi College of Dental Sciences and Research
Faridabad,Haryana
Faridabad HARYANA 121002 India |
Phone |
|
Fax |
|
Email |
mttlrksh@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Garima |
Designation |
Post Graduate student |
Affiliation |
Sudha rustagi college of dental sciences and research |
Address |
PG Section, Room No 7
Department of Conservative Dentistry and Endodontics
Sudha rustagi college of dental sciences and research
Sector-89 Kheri more
Faridabad HARYANA 121002 India |
Phone |
9711222414 |
Fax |
|
Email |
garimagk20@gmail.com |
|
Source of Monetary or Material Support
|
Sector-89 Kheri more
Sudha Rustagi College of Dental Sciences and Research
Faridabad
Haryana 121002
|
|
Primary Sponsor
|
Name |
Garima |
Address |
Sector-89 Kheri more Sudha Rustagi College of Dental Sciences and Research Faridabad Haryana 121002 |
Type of Sponsor |
Other [(Self)] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Garima |
Sudha rustagi college of dental sciences and research |
PG Section, Room No 7
Department of Conservative Dentistry and Endodontics
Sector-89 Kheri more Faridabad HARYANA |
9711222414
garimagk20@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
No Objection Certificate |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Permanent teeth with necrotic or infected pulp as diagnosed clinically and radiographically with adequate coronal structure for proper isolation, temporization, and restoration. |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Ozonated Olive oil |
Ozonated olive oil with and without ultrasonic activation as root canal irrigant |
Comparator Agent |
Sodium hypochlorite |
Sodium hypochlorite with and without ultrasonic activation as root canal irrigant |
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
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.
|
|
ExclusionCriteria |
Details |
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. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Microbial colonies |
24 hours of incubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Microbial colonies count |
after 24 hours |
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
|
05/08/2019 |
Date of Study Completion (India) |
31/01/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The aim of the
present study was to in- vivo evaluate the antimicrobial efficacy of commercially
available ozonated olive oil with and without ultrasonic activation as root
canal irrigant in primary endodontic infections and compare with conventional
irrigant i.e. 2.5% Sodium hypochlorite.
In the present
study, fifty six patients with single rooted teeth were selected. After local anaesthetic administration and rubber
dam placement, access cavity was made. Working length was determined using an apex
locator and confirmed radiographically. Pretreatment sample (S1) was obtained
with a paper point by injecting normal saline (5 ml) into the root canal and
transporting it into the peptone water. Biomechanical preparation was done up
to the working length with master apical file size #40 and step back up to size
#60. The patients were randomly divided
into four groups (n=14) - Group 1: 2.5% Sodium hypochlorite, Group 2: 2.5%
Sodium hypochlorite with ultrasonic activation, Group 3 : Ozonated olive oil
and Group 4: Ozonated olive oil with ultrasonic activation. Irrigation was done
with the respective irrigants during the biomechanical preparation and in Group
2 and Group 4 irrigant was passively activated by ultrasonics. Post
instrumentation and irrigation sample (S2) was collected in the same manner as
S1. Microbiological samples (S1, S2) were preincubated for 30 minutes and
shaken vigorously in a vortex mixture for 60 seconds and then it was plated on
Brain heart infusion agar and colonies were counted after 24 hours of incubation
using classic bacterial counting method. The results of
this study demonstrated that in intragroup comparison, statistically significant
reduction was found from S1 to S2 in all the four experimental groups. In
intergroup comparison the mean reduction of bacterial counts of Group 1 (Sodium
Hypochlorite) and Group 3 (Ozonated olive oil) were found to be lower than that
of Group 2 (Sodium Hypochlorite with ultrasonic activation) and Group 4
(Ozonated olive oil with ultrasonic activation). However, the difference was
not statistically significant between Group 1 (Sodium Hypochlorite) and Group 3
(Ozonated olive oil) but the difference was statistically significant between
Group 2 (Sodium Hypochlorite with ultrasonic activation) and Group 4 (Ozonated
olive oil with ultrasonic activation) with highest mean percentage bacterial
reduction seen in Group 2 (Sodium Hypochlorite with ultrasonic activation). |