| CTRI Number |
CTRI/2025/11/096751 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of dental caries preventive techniques |
|
Scientific Title of Study
|
Clinical and Cost-effectiveness of preventive measures in children- a community trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHARATHI M PUROHIT |
| Designation |
Associate Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Centre for Dental Education and Research, Room No. 613, 6TH floor AIIMS New Delhi, Ansari Nagar East 110029
Centre for Dental Education and Research, Room No. 613, 6TH floor AIIMS New Delhi, Ansari Nagar East 110029
New Delhi
DELHI
110029
India |
| Phone |
7898842426 |
| Fax |
|
| Email |
bharathipurohit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BHARATHI M PUROHIT |
| Designation |
Associate Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Ansari Nagar East
CDER 613, 6TH floor
New Delhi
DELHI
110029
India |
| Phone |
7898842426 |
| Fax |
|
| Email |
bharathipurohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHARATHI M PUROHIT |
| Designation |
Associate Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Ansari Nagar East
CDER 613, 6TH floor
New Delhi
DELHI
110029
India |
| Phone |
7898842426 |
| Fax |
|
| Email |
bharathipurohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS New Delhi Intramural grants |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Ansari Nagar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| BHARATHI M PUROHIT |
Trilokpuri AIIMS Rotary Hospital |
Room no 3, Dental OPD
East
DELHI |
7898842426
bharathipurohit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
| NOC_Trilokpuri_Hospital |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children having at least one erupted permanent molar |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GIC |
Glass Ionomer Cement is used in Atraumatic Restorative Treatment (ART) which is endorsed by WHO as an effective measure in controlling caries. |
| Intervention |
SMART |
Silver diamine fluoride modified atraumatic restorative technique (SMART) come under the umbrella of preventive restorations and are effective for arresting caries, aimed at maximum conservation of the tooth with least psychological impact on the patient. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children aged six to seven years attending public schools at Trilokpuri
Children with parental consent
Children with at least one fully-erupted caries-free first permanent molar determined at baseline examination
|
|
| ExclusionCriteria |
| Details |
Children whose medical history or systemic illness precludes inclusion like asthma or severe allergies
Children with known sensitivity to any ingredient in the dental product like methylacrylate in PFS
Children with ulcerative gingivitis or stomatitis or oral infections which preclude dental procedure
Children currently participating in another clinical trial involving a medicinal product
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Reduction in the proportion of children developing new caries on any of the treated first permanent and deciduous molars in children aged 6-7 years over a period of 2 years |
• Reduction in the proportion of children developing new caries on any of the treated first permanent and deciduous molars in children aged 6-7 years over a period of 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/11/2025 |
| 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="2"
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
|
the aim of this
community trial is to compare the clinical and cost effectiveness of sealants
versus varnish in preventing dental caries in first permanent molars in
6–7-year-olds; and SMART versus conventional GIC in primary teeth of
6–7-year-old children. The trial design comprises a randomized four-arm,
parallel groups in the required age group for the preventive caries techniques.
Clinical procedures and assessments will be performed at two primary schools,
in Trilokpuri, which is an outreach OPD of AIIMS New Delhi. In total,
approximately 360 children will be recruited (90 per trial arm for 4 arms of
the trial). Fluoride varnish will be applied at baseline and every 6 months
through 2-year period (0, 6, 12, 18 and 24 months) and sealant will be applied
at baseline and reapplication performed as required until 2 years after the
initial application. |