| CTRI Number |
CTRI/2018/08/015524 [Registered on: 29/08/2018] Trial Registered Prospectively |
| Last Modified On: |
27/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Topical agents in arresting dental caries |
|
Scientific Title of Study
|
Efficacy of 38% silver diamine fluoride (SDF) and 5% sodium fluoride (SF) in dental caries prevention- A double blinded parallel group multicenter randomised trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahesh |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College & Hospital |
| Address |
Clinic no 28, Department of Pedodontics
Saveetha Dental College& Hospital
Saveetha University
Chennai, India
Clinic no 28, Department of Pedodontics
Saveetha Dental College& Hospital
Saveetha University
Chennai, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
04426801583 |
| Fax |
|
| Email |
maheshpedo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahesh |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College & Hospital |
| Address |
Department of Pedodontics
Saveetha Dental College
Saveetha University
Chennai, India
Clinic no 28, Department of Pedodontics
Saveetha Dental College& Hospital
Saveetha University
Chennai, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
maheshpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahesh |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Pedodontics
Saveetha Dental College
Saveetha University
Chennai, India
Clinic no 28 Department of Pedodontics
Saveetha Dental College
Saveetha University
Chennai, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
maheshpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Padma Dental |
| Address |
Pallavan Nagar main road
Thiruverkadu
Chennai |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 DhanalakshmiR |
Saveetha Dental College |
Clinic no 28, Department of Pedodontics,
166, velapanchavadi main road,
Poonamallee High Road, Chennai 600077
Thiruvallur
TAMIL NADU |
9840322728
maheshpedo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Univerisity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Early Childhood Caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
38% silver diamine fluoride |
Silver diamine fluoride is globally accepted treatment for topical application to arrest dental Caries in children |
| Comparator Agent |
5% sodium fluoride varnish |
Fluoride varnish is most commonly used to arrest Caries progression |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Cooperative children with one or more smooth surface Caries.
2. Parents and children willing to participate.
3. Healthy children |
|
| ExclusionCriteria |
| Details |
1. Parents not willing to participate.
2. Children with known allergy or any systemic illness. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in incidence of new carious lesion |
3months, 6months and 1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in plaque index scores |
3months, 6months and 1year |
| R suction in S mutans level in plaque and saliva |
3months, 6months and 1year |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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 |
|
Date of First Enrollment (India)
|
01/10/2018 |
| 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="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: Early Childhood Caries (ECC) is one of the most common infectious diseases in children, mainly due to improper feeding habits. Children affected with ECC show signs and symptoms of delayed growth, development due to inability in proper mastication. Background: Various topical agents have been tried to reduce the incidence of Dental caries in children, but there is a lacunae in identifying the effectiveness of commercially available agents. Hence the study aim to analyse the effectiveness of topical application of silver diamine fluoride and sodium fluoride varnish in reducing the carious progression and incidence of new carious lesions in children diagnosed with severe Early childhood caries. |