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CTRI Number  CTRI/2025/12/098793 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An In Vivo Evaluation of the Efficacy of Dyes in the Detection of Root Canal Orifices in Primary Molars during Endodontic Procedures 
Scientific Title of Study   comparison of detection rate and ease of locating root canal orifices in primary molars using methylene blue dye versus ophthalmic dye an in vivo study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nikita Kishor Jakhotiya  
Designation  Post graduate student 
Affiliation  pdch udaipur 
Address  Pacific Dental College and Hospital Department of Pediatric and preventive dentistry room no 9 Debari Udaipur RAJASTHAN 313024 India Udaipur RAJASTHAN 313024 India
Pacific Dental College and Hospital Department of Pediatric and preventive dentistry room no 9 Debari Udaipur RAJASTHAN 313024 India Udaipur RAJASTHAN 313024 India
Udaipur
RAJASTHAN
313024
India 
Phone  07588718610  
Fax    
Email  nikitajakhotiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dinesh Rao 
Designation  Head of department PG guide 
Affiliation  Pacific Dental College And Hospital  
Address  Pacific Dental College And Hospital Department of Pediatric and preventive dentistry room no 9, Debari, Udaipur RAJASTHAN 313024 India Udaipur RAJASTHAN 313024 India

Udaipur
RAJASTHAN
313024
India 
Phone  09414158235  
Fax    
Email  pedodinesh2003@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Dinesh Rao 
Designation  Head of department PG guide 
Affiliation  Pacific Dental College And Hospital  
Address  Pacific Dental College and Hospital Department of Pediatric and preventive dentistry room no 9 Debari Udaipur RAJASTHAN 313024 India Udaipur RAJASTHAN 313024 India

Udaipur
RAJASTHAN
313024
India 
Phone  09414158235  
Fax    
Email  pedodinesh2003@yahoo.co.in  
 
Source of Monetary or Material Support  
Pacific Dental College And Hospital Debari Udaipur 313024 
 
Primary Sponsor  
Name  Nikita Kishor Jakhotiya 
Address  Pacific Dental College And Hospital Department of Pediatric and preventive dentistry room no 9, Debari, Udaipur RAJASTHAN 313024 India Udaipur RAJASTHAN 313024 India 
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 Nikita Kishor Jakhotiya  Pacific Dental College and Hospital Debari  Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024 Udaipur RAJASTHAN
Udaipur
RAJASTHAN 
07588718610

nikitajakhotiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pacific Dental College and Hospital Udaipur Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  methylene blue dye  Methylene blue dye is a safe commonly used vital stain that enhances contrast within the pulp chamber helping clinicians clearly identify root canal orifices and the rate of detection will be recorded at the baseline 
Intervention  ophthalmic dye  Ophthalmic dye is a sterile biocompatible diagnostic dye used to enhance visibility of anatomical details aiding precise identification of root canal orifices the rate of detection will be recorded at the baseline  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  primary molars requiring pulpectomy Restorable tooth with adequate coronal structure after minimal caries removal to allow isolation and safe access presence of at least twothirds of root length and no advanced physiological root resorption Cooperative behaviour sufficient for treatment in the dental office No known allergy or hypersensitivity to study dyes or any components 
 
ExclusionCriteria 
Details  Teeth with advanced physiological or pathological root resorption Teeth with severe crown destruction Internal or external pathological resorption vertical root fractures or grossly abnormal anatomy on clinical or radiographic exam Presence of a draining sinus tract or extensive acute orofacial swelling Systemic conditions that contraindicate routine dental care Uncooperative behaviour requiring general anaesthesia Known hypersensitivity or allergy to any components of the dyes 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Detection rate of root canal orifices  at baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Ease of locating canal orifices Time taken to locate all canal orifices  at the baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   20/12/2025 
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)   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  

Accurate identification of root canal orifices is a crucial step in performing successful pulpectomy in primary molars, yet it is often challenging due to complex canal morphology, limited visibility, and behavioral constraints in pediatric patients. Diagnostic dyes have been proposed as useful adjuncts to enhance contrast and improve visualization during endodontic access. This randomized in vivo study aims to compare the effectiveness of two commonly used dyes—ophthalmic dye and methylene blue dye—in enhancing the detection of root canal orifices in primary molars of children aged 5–9 years. Eligible teeth requiring pulpectomy will be randomly assigned to either ophthalmic dye (Group I) or methylene blue dye (Group II) following standard access cavity preparation. The primary outcomes include the number of canal orifices successfully located and the operator-reported ease of detection using a standardized scoring scale. Data will be analyzed using appropriate statistical tests such as chi-square and independent t-tests. The study seeks to determine whether ophthalmic dye provides comparable or improved visualization relative to methylene blue. Findings may support the use of these dyes as reliable, safe, and cost-effective adjuncts to improve accuracy and efficiency in pediatric endodontic procedures.

 
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