| CTRI Number |
CTRI/2025/12/098979 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing a dye and a gel for finding plaque in children |
|
Scientific Title of Study
|
An in vivo comparative study on the efficiency of a disclosing dye and a gel in detection of dental plaque among pediatric patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kareena Singh |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital Debari Udaipur |
| Address |
Pacific dental college and hospital debari Udaipur Rajasthan
Department of Pediatric and Preventive Dentistry room no 9 pacific dental college and hospital debari udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
9099125725 |
| Fax |
|
| Email |
dr.skareena099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Head of Department PG Guide |
| Affiliation |
Pacific Dental College And Hospital Debari |
| Address |
Department of pediatric and preventive dentistry room no 9 Pacific dental college and hospital debari udaipur
Department of pediatric and preventive dentistry room no 9 Pacific dental college and college and hospial udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
07340659914 |
| 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 Debari |
| Address |
Department of pediatric and preventive dentistry room no 9 Pacific dental college and hospital debari udaipur
Department of pediatric and preventive dentistry room no 9 Pacific dental college and college and hospial udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
07340659914 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry room no 9 Pacific dental college and Hospital debari Udaipur rajasthan 313024 |
|
|
Primary Sponsor
|
| Name |
Kareena Singh |
| Address |
Department of pediatric and preventive dentistry room no 9 Pacific dental college and hospital debari Udaipur rajasthan 313024 |
| Type of Sponsor |
Other [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 |
| Kareena Singh |
Pacific dental college and hospital debari udaipur |
Department of pediatric and preventive dentistry room no 9 Pacific dental college and hospital debari udaipur
Udaipur
RAJASTHAN |
9414158235
pedodinesh2003@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| pacific dental college and hospital, debari Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Disclosing dye |
in group 1 for plaque detection |
| Comparator Agent |
Disclosing gel |
in group 2 for plaque detection |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative children aged between 6 to 8 years Frankl rating 3 or 4
Children with good physical and mental health without any history of systemic disease
patient requiring oral prophylaxis
|
|
| ExclusionCriteria |
| Details |
Non-cooperative children Frankl rating 1 or 2
those who are allergic to dye or gel
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Application time
Mean plaque score |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient acceptance
Operator acceptance |
Checked by likert rating scale |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
22/12/2025 |
| 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
|
Introduction:
Dental
plaque is a key factor in the development of caries and periodontal disease,
particularly in children due to their developing oral hygiene habits.
Disclosing agents are effective tools for visualizing plaque accumulation.
While both disclosing dyes and gels are widely used, comparative evidence
regarding their effectiveness in paediatric patients is limited.
Objective:
To compare
the effectiveness of a disclosing dye and a disclosing gel in detecting dental
plaque among paediatric patients and evaluate their plaque visibility, ease of
application, and acceptance by both patients and operators.
Methodology:
A
randomized in vivo study was conducted in children aged 6–13 years.
Participants were equally divided into two groups: disclosing gel group
(erythrosine gel) and disclosing dye group (two-tone dye). Each participant
underwent plaque disclosure, with application time recorded. Clinical
examination was performed using the Turesky Modification of the Quigley-Hein
Plaque Index. Plaque visibility, ease of use, and acceptance were assessed
using a Likert scale.
Results:
Both agents
effectively disclosed plaque. However, the gel group demonstrated significantly
higher mean plaque scores, indicating better visualization. The gel was also
preferred for its pleasant taste, controlled flow, and ease of use, leading to
higher patient and operator acceptance.
Conclusion:
The
erythrosine disclosing gel proved more effective than the traditional dye in
detecting plaque and was better accepted by paediatric patients. It is
recommended as a superior tool for plaque assessment and oral hygiene education
in children |