| 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
|
|
|
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
|
|
|
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. |