| CTRI Number |
CTRI/2024/08/071768 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Acceptance of Silver Diamine Fluoride vs. Sodium Varnish in Pediatric Patients |
|
Scientific Title of Study
|
Comparing Child Acceptance Silver Diamine Fluoride versus Sodium Varnish for Pediatric Dental Treatment
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mithula Raj |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College And Hospitals |
| Address |
Saveetha Dental College And Hospitals
162, Poonamallee High Road, Velappanchavadi,Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9539655505 |
| Fax |
|
| Email |
mithularaj96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vignesh Ravindran |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College And Hospitals |
| Address |
Saveetha Dental College And Hospitals
162, Poonamallee High Road, Velappanchavadi,Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9789934476 |
| Fax |
|
| Email |
vigneshr.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Mithula Raj |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College And Hospitals |
| Address |
Saveetha Dental College And Hospitals
162, Poonamallee High Road, Velappanchavadi,Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9539655505 |
| Fax |
|
| Email |
mithularaj96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College And Hospitals
162, Poonamallee High Road, Velappanchavadi,Chennai |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College And Hospitals |
| Address |
Saveetha Dental College And Hospitals
162, Poonamallee High Road, Velappanchavadi,Chennai |
| Type of Sponsor |
Private medical college |
|
|
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 Mithula Raj |
Saveetha dental college and hospitals |
Clinic 28
Department of pedodontics and preventive dentistry
Chennai
TAMIL NADU |
9539655505
mithularaj96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Silver Diamine Fluoride
Kedo SDF (38%) |
Non invasive treatment option for cavities which is topically applied
Kedo SDF applied on the tooth surface for a duration of 2 minutes with proper isolation
|
| Comparator Agent |
Sodium Fluoride Varnish (5%)
VOCO profluorid varnish
|
Topically applied coating liquid for teeth to prevent cavities
5% varnish a thin layer is applied using single applicator tip was carried out for 4 minutes |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children who have not received prior Silver Diamine Fluoride (SDF) or varnish treatments
Children requiring fundamental dental procedures, specifically those in need of dental restorations
Children with non-cavitated teeth.
|
|
| ExclusionCriteria |
| Details |
Children who have systemic health issues
Children who necessitate advanced dental procedures
Children with specific dental conditions, such as hypoplastic or attrited teeth, or allergies to silver
Children with any degree of dental or skeletal fluorosis
Children using alternative home care routines, like mouthwash, and those with teeth affected by trauma, hypoplasia, cavities, or attrition
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Behavioural Rating |
Baseline
After 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parental satisfacation |
Baseline
After 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/08/2024 |
| Date of Study Completion (India) |
29/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Dental caries is a chronic, complex, site-specific illness that affects people worldwide. Fluoride topical agents can be used to prevent dental caries. Early carious lesions are remineralized by topical fluoride, while healthy enamel is remineralized by oral fluoride. Silver Diamine Fluoride (SDF) and Sodium Varnish (NaF) are two frequently used topical fluoride therapies in paediatric dentistry, to prevent dental cavities. In order to guarantee patient compliance and treatment effectiveness, it is crucial to assess the acceptance of these treatments by children. |