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CTRI Number  CTRI/2021/03/032107 [Registered on: 18/03/2021] Trial Registered Prospectively
Last Modified On: 16/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Evaluation of ozone therapy in endodontic treatment of teeth with pulpal diseases 
Scientific Title of Study   Evaluation of ozone therapy in endodontic treatment of teeth with necrotic pulp and apical periodontitis: A randomised clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nidhi Sinha 
Designation  Professor 
Affiliation  Pacific dental college and hospital 
Address  Department of conservative dentistry and endodontics Pacific dental college and hospital Udaipur Rajasthan
Pacific dental college and hospital Airport road Debari
Udaipur
RAJASTHAN
313024
India 
Phone  8619423478  
Fax    
Email  dr.nidhi.sinha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geeta Asthana 
Designation  Professor and guide 
Affiliation  Government dental college and hospital Ahmadabad 
Address  Department of conservative dentistry and endodontics Government dental college and hospital Civil hospital road Asarwa road Ahmedabad Gujarat
Department of conservative dentistry and endodontics Government dental college and hospital Civil hospital road Asarwa road Ahmedabad Gujarat
Ahmadabad
GUJARAT
380016
India 
Phone  9824440656  
Fax    
Email  geetasthana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nidhi Sinha 
Designation  Professor 
Affiliation  PACIFIC DENTAL COLLEGE AND HOSPITAL 
Address  Department of conservative dentistry and endodontics Pacific dental college and hospital Udaipur Rajasthan
Pacific dental college and hospital Airport road Debari Udaipur
Udaipur
RAJASTHAN
313024
India 
Phone  8619423478  
Fax    
Email  dr.nidhi.sinha@gmail.com  
 
Source of Monetary or Material Support  
Pacific dental college and hospital 
 
Primary Sponsor  
Name  Pacific dental college and hospital 
Address  Pacific dental college and hospital Debari Udaipur  
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 NIDHI SINHA   PACIFIC DENTAL COLEGE AND HOSPITAL  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS PACIFIC DENTAL COLLEGE AND HOSPITAL DEBARI UDAIPUR
Udaipur
RAJASTHAN 
8619423478

dr.nidhi.sinha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PACIFIC DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ozone activation in single rooted teeth during endodontic treatment  Ozone irrigation prepared by Dentozone ozonator by ADC India activated by manual agitation  
Comparator Agent  Ozone activation in single rooted teeth during endodontic treatment  Ozone irrigation prepared by Dentozone ozonator by ADC India activated by pro agitator tips system (PATS) 
Comparator Agent  Ozone activation in single rooted teeth during endodontic treatment  Ozone irrigation prepared by Dentozone Ozonator by ADC India activated by ultra-sonic agitation 
Intervention  Use of ozone as irrigant in single rooted teeth during endodontic treatment  Ozone irrigation prepared by Dentozone ozonator by ADC India used without activation 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients will be selected at random, irrespective of age, sex, caste, religion, etiology and socioeconomic status .
2.Patients with good general health.
3.Patients readily available for follow up.
4.Patient willing to give consent for the study.
5.Patient’s teeth with necrotic pulps and apical periodontitis.
(Primary/ Secondary endodontic treatment).

6.Presence of sufficient coronal tooth structure for rubber dam isolation.

7.Teeth with sound periodontal apparatus will be included in the study.
 
 
ExclusionCriteria 
Details  1.Patients with any systemic diseases, immune-compromised patients.

2.Patients allergic to ozone, recent myocardial infarction, acute alcohol intoxication, active bleeding, uncontrolled hyperthyroidism, thrombocytopenia, Glucose 6 phosphatase deficiency (Contraindications of ozone therapy).

3.Patients on analgesics or antibiotics five days prior to the clinical procedure.

4.Patients unwilling for follow up visits
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain assessment following Ozone irrigation in endodontic treatment of single rooted teeth  0 hours,6 hours, 12 hours, 24 hours , 48 hours, and 7 days  
 
Secondary Outcome  
Outcome  TimePoints 
Pain assessment following Ozone irrigation in endodontic treatment of single rooted teeth  0 hours,6 hours, 12 hours, 24 hours , 48 hours, and 7 days  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   N/A 
Date of First Enrollment (India)   21/03/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.nidhi.sinha@gmail.com].

  6. For how long will this data be available start date provided 21-03-2021 and end date provided 21-03-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

 Need for the study:

 The success of endodontic treatment is highly related to the elimination or reduction of post-endodontic pain, many clinical studies have reported varying degrees of pain, ranging from 25 to 40%. Postoperative pains in patient undergoing root canal treatment is an undesirable complication in dental practice for both patient and dentist. The agent that triggers these events may have different origins, such as physic, chemical or microbiological; however, the latter seems to be the main cause of postoperative pain. The intensity of the inflammatory reaction can be influenced by several factors such as the degree of existing pathological changes in the periapical region, presence of certain bacterial species in the root canal.

Current literature on number of visits for root canal treatment provides conflicting opinions and recommendations. However, single-visit root canal treatment has become a common practice and offers several advantages, including decreased number of operative procedures, less time consuming, more economical for busy patients and no risk of inter-appointment leakage through temporary restorations. The disadvantages of single visit procedures are also obvious as it eliminates some of the controls available in the multiple visit procedures, such as culturing to check the effectiveness of the biomechanical preparation. But with meticulously instrumentation and irrigation in a single-visit root canal treatment a better disinfection and pain management can be achieved.

In endodontics, root canal irrigation is an integral part of preparation, which plays an important role in disinfection and removal of the debridement. The ideal irrigant should be strongly antimicrobial, able to dissolve the necrotic tissues, the remaining organic tissues, and be non-toxic to the periapical tissues if extruded through the apex. Not only irrigation solution but also the irrigation technique plays a crucial role in successful endodontic treatment. Therefore, newer irrigation solutions and techniques have to be tested to achieve this goal.

 One such new generation of the disinfectant agents is ozone; a powerful oxidizing agent used to eliminate bacteria in root canals. Recent investigations of aqueous ozone have indicated that it is a powerful antimicrobial agent against oral pathogens and even resistant microorganisms too. One of the crucial properties of aqueous ozone is its non toxicity to oral cells in vitro than all other known antiseptics. However, the most important disadvantage of aqueous ozone is its unstable concentration in a long time. Consequently, aqueous ozone should be used as soon as possible after obtaining the ozone generator.   

 Irrigant exchange can be further improved in a number of ways, including pressure alteration, sonics, and ultrasonics. The simplest is manual dynamic agitation technique in which the obturating gutta-percha cone is pumped up and down in the canal.  The literature is scarce on studies that evaluate whether efficacy of Ozone can be optimized by the use of the ultrasonic, pro-agitator tip system (PATS) or manual dynamic agitation.

 Hence, the present study will aim to evaluate and compare the post-treatment pain after single-visit endodontics with three different Ozone application techniques (manual and ultrasonic and pro agitator tip system (PATS).


 
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