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CTRI Number  CTRI/2023/02/049482 [Registered on: 06/02/2023] Trial Registered Prospectively
Last Modified On: 12/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare and evaluate the antimicrobial efficacy (in terms of bacterial load reduction) of combination of ozone oil with Chitosan Nano-particle and Double Antibiotic Paste as intracanal medicament in teeth requiring retreatment of previously done root canal therapy. 
Scientific Title of Study   Comparative evaluation of antimicrobial efficacy of Combination of Ozone oil with Chitosan Nano-Particle and double antibiotic paste as intracanal medicament in Endodontic Retreatment– A randomized clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harshit Tushar Mavani 
Designation  Post Graduate Student 
Affiliation  KM Shah Dental College and Hospital Sumandeep Vidyapeeth 
Address  Sumandeep Vidyapeeth,At & Po. Pipariya, Taluka Waghodia, Dist, Vadodara, Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  08460242073  
Fax    
Email  harshitmavani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishan KV 
Designation  Professor and Post Graduate guide 
Affiliation  K.M Shah Dental College and Hospital 
Address  Room no.8, Conservative Dentistry and endodontics, Sumandeep Vidyapeeth,Pipariya Road,Waghodia- Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8141787335  
Fax    
Email  drkishankv@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kishan KV 
Designation  Professor and Post Graduate guide 
Affiliation  K.M Shah Dental College and Hospital 
Address  Room no.8, Conservative Dentistry and endodontics, Sumandeep Vidyapeeth,Pipariya Road,Waghodia- Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8141787335  
Fax    
Email  drkishankv@yahoo.co.in  
 
Source of Monetary or Material Support  
K.M. Shah Dental College and Hospital, Sumandeep Vidyapeeth 
 
Primary Sponsor  
Name  Dr Harshit Mavani 
Address  Sumandeep Vidyapeeth, At & Po. Pipariya, Taluka Waghodia, Dist, Vadodara, Gujarat 391760 
Type of Sponsor  Other [Self Funded] 
 
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 Harshit Mavani  K.M Shah Dental College and Hospital  Room no.8,Department of Conservative Dentistry and Endodontics, K.M.Shah Dental College and Hospital
Vadodara
GUJARAT 		 8460242073

harshitmavani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, (2) ICD-10 Condition: K045||Chronic apical periodontitis, (3) ICD-10 Condition: K045||Chronic apical periodontitis, (4) ICD-10 Condition: K045||Chronic apical periodontitis, (5) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination of Chitosan Nano-Particle with ozonated oil  Ozones strong biocompatibility and antiviral, antifungal, and antibacterial properties have led to its usage in the medical profession. Ozone-treated olive oil has been used to treat post-extraction alveolitis because it has strong antimicrobial and oxygenating properties against a variety of bacteria. Chitosan Nano-Particle functions as a broad-spectrum, biocompatible antibacterial agent. Chitosan Nano-Particle may also aid in the remineralization of dentin by forming a link with the calciums functional phosphate group. Chitosan Nano-Particles will be prepared by an ionotropic gelation technique. It will be mixed with Ozonated Oil until the mixture will exhibit a thick creamy consistency, which will be immediately carried on the master cone and inserted into the canal. Route - Topical (intra-canal medicament). It will be removed after 7 days of application. 
Comparator Agent  Double antibiotic paste  The use of triple antibiotic paste has reduced due to the discolouring effect of minocycline. Double antibiotic paste is thus the intracanal medicaament of choice for cases of endodontic retreatment. Equal amounts of metronidazole and ciprofloxaacin will be mixed and applied in the root canal. It will be removed after a period of 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Systemically healthy patients, i.e., Class I patients according to American Society of Anaesthesiology [ASA] classification having multirooted teeth diagnosed with post treatment apical periodontitis will be included.

Teeth indicated for endodontic retreatment will be included.

A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
 
 
ExclusionCriteria 
Details  Patients who received antibiotic therapy within the previous 3 months

Teeth with vertical root fracture

Teeth with periodontal pockets deeper than 4 mm

Teeth in which prosthesis could not be removed.

Teeth with severe crown destruction

Teeth with separated instrument

Patients with known allergy to Shrimps/Chitosan
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The result of this study will help us to know about the antibacterial efficacy of combination of ozone oil with chitosan nanoparticle as intracanal medicament  First sample will be taken at baseline. Second sample will be taken after a week (7 days) 
 
Secondary Outcome  
Outcome  TimePoints 
To know which has better antibacterial activity between combination of ozone oil with chitosan nanoparticle and double antibiotic paste  7 days 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2023 
Date of Study Completion (India) 01/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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 - 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 [harshitmavani@gmail.com].

  6. For how long will this data be available start date provided 24-11-2023 and end date provided 24-01-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Innovative approaches are necessary to prevent and eradicate biofilm formation. Antimicrobial, antibiofilm and anti-virulent efficacy of Chitosan Nano-Particle Nano-particles and O3-oil against the S. mutans, E. faecalis, and C. albicans bacterial-fungal biofilm that is encountered in many resistant endodontic infections can be tested to prove their efficacy in doing so. Little is known about in vivo efficacy of ozonated oil with Chitosan Nano-Particle nanoparticles against microbial species isolated from persistent endodontic infections. The present study is aimed to evaluate the antibacterial effect of combination of Chitosan Nano-Particle Nanoparticles with ozonated oil- used as an intracanal medicament in endodontic retreatment, as there were no studies searched on PubMed, Cochrane, Google Scholar and Science Direct. 
Therefore, the aim of this study is to evaluate and compare antibacterial efficacy of combination of Chitosan Nano-Particle with ozonated oil and Double Antibiotic Paste in Endodontic retreatment using bacterial colony forming units.


 
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