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CTRI Number  CTRI/2024/05/068201 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Assessment of the efficacy of medicament in diseased root canals. 
Scientific Title of Study   Analysis of microorganisms found in Root canal with Periapical lesions and evaluation of antimicrobial efficacy of combination of Calcium Hydroxide and Chitosan as Intracanal Medicaments. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Srishti S Chatterjee 
Designation  Post Graduate Trainee 
Affiliation  Institute Of Dental Sciences 
Address  Room No-7, Second floor, Department of Conservative Dentistry & Endodontics, Intitute of Dental Sciences, SUM Hospital, Kalinga Nagar, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8249326708  
Fax    
Email  srishti29897@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashirekha Govind 
Designation  Head of the Department  
Affiliation  Institute Of Dental Sciences 
Address  Room No-7, Second floor, Department of Conservative Dentistry & Endodontics, Intitute of Dental Sciences, SUM Hospital, Kalinga Nagar, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8249326708  
Fax    
Email  shashirekhag@soa.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Srishti S Chatterjee 
Designation  Post Graduate Trainee 
Affiliation  Institute Of Dental Sciences 
Address  Room No-7, Second floor, Department of Conservative Dentistry & Endodontics, Institute of Dental Sciences, SUM Hospital, Kalinga Nagar, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8249326708  
Fax    
Email  srishti29897@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, Siksha O Anusandhan Deemed to be University, Bhubaneswar, Odisha -751003, India 
 
Primary Sponsor  
Name  Institute of Dental Sciences 
Address  Room No- 7, Second floor, Department of Conservative Dentistry & Endodontics,Institute of Dental Sciences, SUM Hospital, Bhubaneswar 751003, Odisha, India 
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 Srishti Chatterjee  Institute Of Dental Sciences  Room No 7, Second Floor, Institute Of Dental Sciences, Kalinga Nagar, Bhubaneswar 751003, Odisha, India
Khordha
ORISSA 		 8249326708

srishti29897@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC- Institute of Dental Sciences  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Calcium Hydroxide   Pre mixed calcium hydroxide paste will be used which is kept in the canals for 14 days 
Intervention  Calcium Hydroxide + Chitosan  0.05g of calcium hydroxide powder freshly mixed with 0.1ml 3% chitosan liquid to form a paste like consistency which will be applied to canals using lentulospirals for 14 days 
Comparator Agent  Calcium hydroxide + Chlorhexidine  0.05g of calcium hydroxide powder freshly mixed with 0.1ml 2% chlorhexidine to obtain a paste like consistency which is kept in the canals for 14 days 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with periapical lesions
Age (17-65 yrs)
Single and multi-rooted teeth 
 
ExclusionCriteria 
Details  Any signs of internal or external root resorption
Mobility of teeth
History of taking antibiotics within the preceding month 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Healing of periapical lesions  1 month, 3 months, 6 months ,12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain  1 week , 1 month, 12 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   19/06/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [srishti.moon29@gmail.com].

  6. For how long will this data be available start date provided 29-04-2024 and end date provided 07-06-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Detailed case history including demographic details, medical history, oral health assessment status of the patients will be recorded. Radiographic examination will be done to evaluate the periapical status of the involved teeth. Based on the intracanal medicaments used, samples will be categorised in 3 groups:- 
Group A - Calcium hydroxide alone
Group B - Calcium Hydroxide + Chlorhexidine
Group C - Calcium Hydroxide + Chitosan
Access opening will be done under rubber dam isolation after administration of local anesthesia. After locating the orifices, they are enlarged using orifice openers. First microbial samples will be collected using No 15/4% paper points keeping them within the canals for a minute. These paper points will be transferred to Institute’s Central Laboratory for microbiological assays and evaluation along with qualitative PCR. Intracanal medicaments will be placed inside the canals using lentulospirals and the patients are recalled after 14 days. In second appointment, after re-access opening, second microbial samples will be collected using No 15/4% paper points which will again be sent to the lab to identify the microorganisms along with its colony forming units to evaluate the decrease/increase in microbial load. Obturation will be done followed by composite access restoration. The obtained data will be subjected to statistical analysis. All the above procedures will be done after taking patients’ written consent.
 
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