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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).


 
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