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CTRI Number  CTRI/2024/09/074489 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 27/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to assess the postoperative effects of using ozonated water and sodium hypochlorite in a visit root canal procedure. 
Scientific Title of Study   Comparative evaluation of postoperative effects of ozonated water and sodium hypochlorite in endodontic treatment of teeth with symptomatic apical periodontitis : A randomized clinical trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AAYUSH PARESH BHATT 
Designation  Postgraduate Student 
Affiliation  Krishna Vishwa Vidhyapeeth 
Address  31/ Department of Conservative Dentistry and Endodontics, School of Dental Sciences, Malkapur - 415539, Karad
31/ Department of Conservative Dentistry and Endodontics, School of Dental Sciences, Malkapur - 415539, Karad
Satara
MAHARASHTRA
415539
India 
Phone  9322238483  
Fax    
Email  bhtayush4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Roshan Samuel 
Designation  Head of Department 
Affiliation  Krishna Vishwa Vidhyapeeth 
Address  31/ Department of Conservative Dentistry and Endodontics , School of Dental Sciences , Krishna Vishwa Vidyapeeth, Malakapur, Karad Satara MAHARASHTRA 415539 India
31/ Department of Conservative Dentistry and Endodontics , School of Dental Sciences , Krishna Vishwa Vidyapeeth, Malakapur, Karad Satara MAHARASHTRA 415539 India
Satara
MAHARASHTRA
400057
India 
Phone  9820497011  
Fax    
Email  spkroshan1974@gmail.com  
 
Details of Contact Person
Public Query  
Name  AAYUSH PARESH BHATT 
Designation  Postgraduate Student 
Affiliation  Krishna Vishwa Vidhyapeeth 
Address  31/ Department of Conservative Dentistry and Endodontics , School of Dental Sciences , Krishna Vishwa Vidyapeeth, Malakapur, Karad Satara MAHARASHTRA 415539 India
31/ Department of Conservative Dentistry and Endodontics , School of Dental Sciences , Krishna Vishwa Vidyapeeth, Malakapur, Karad Satara MAHARASHTRA 415539 India
Satara
MAHARASHTRA
400057
India 
Phone  9322238483  
Fax    
Email  bhtayush4@gmail.com  
 
Source of Monetary or Material Support  
Krishna Vishwa Vidyapeeth, Malkapur, Karad, Maharashtra, India. Pin: 415539 
 
Primary Sponsor  
Name  Krishna Vishwa Vidyapeeth 
Address  Krishna Vishwa Vidyapeeth Deemed to be University, Malakapur, Karad, Maharashtra, India. Pin: 415539 
Type of Sponsor  Research institution and hospital 
 
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 Aayush Paresh Bhatt  School of Dental Sciences  Dept no - 31 / Department of Conservative Dentistry and Endodontics, School of Dental Sciences , Malkapur - 415539 , Karad.
Satara
MAHARASHTRA 		 9322238483

bhtayush4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Krishna Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals requiring root canal treatment for teeth with symptomatic apical periodontitis. 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ozonated water  Ozonated water will be made by saturating distilled water at concentration of 35 micrograms/ml for seven minutes with ozone gas generated by medical grade ozone generator with attaching Medical-grade oxygen cylinder to it. This ozonated water has anti-microbial, anti-inflammatory and anti-oxidant effect. This ozonated water will be administered intraorally as an irrigant during the root canal procedure using a 12cc syringe. 
Comparator Agent  Sodium hypochlorite  Sodium hypochlorite is conventionally used as an irrigant during root canal treatment. Sodium hypochlorite (NaOCl) remains the preferred chemical irrigant due to its broad-spectrum antibacterial properties against species involved in endodontic infection, such as Enterococcus faecalis, Actinomyces naeslundii, and Candida albicans , in addition to its ability to dissolve necrotic tissue. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with good general health available for follow-up , Bilateral posterior teeth with symptomatic apical periodontitis , Willingness to sign the informed consent form.
 
 
ExclusionCriteria 
Details  A periapical lesion, abscess or cellulitis, complicating systemic diseases, teeth with open apex, history of allergic reactions to drugs/irrigants, teeth associated with Sinus opening, teeth with calcified canals, teeth with mobility.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Decrease in post-operative pain
 		 At baseline 6hrs
at 12hrs
at 24hrs
at 48hrs
at 72hrs
at 7 days
 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study will evaluate the post-operative effects of using ozonated water as an irrigant during single-visit root canal treatment as compared to sodium hypochlorite as an irrigant. Ozonated water in a concentration of 35 microgram/ml will be used as an irrigant during the root canal treatment where conventionally sodium hypochlorite is used. This will be a cross-arch study in which ozonated water will be used as an irrigant in one arch and sodium hypochlorite in the other. The main objective is to evaluate and compare postoperative pain in patients with symptomatic apical periodontitis using 5.25% sodium hypochlorite and ozonated water as an irrigant. Pain will be measured using a Visual analog scale at a baseline of 6hrs, 12hrs, 24hrs, 48hrs,72hrs and 7 days. Ozone is microbicidal, anti-inflammatory, and anti-oxidant. Its positive effects on short-term and long-term basis are to be assessed in this study. The effects of the ozonated water used as an irrigant during root canal treatment is not known. This study will evaluate the effects of ozonated water used as an irrigant during root canal treatment carried out with conventional technique in terms of post-surgical effects such as pain and inflammation. 
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