| CTRI Number |
CTRI/2019/09/021255 [Registered on: 16/09/2019] Trial Registered Prospectively |
| Last Modified On: |
13/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Two Agents on arrest of Caries in Deciduous Teeth |
|
Scientific Title of Study
|
Effectiveness of Silver Diamine Fluoride and Silver Nitrate with Sodium Fluoride on Caries in Deciduous Teeth |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sona G Therathil |
| Designation |
Post Graduate Student |
| Affiliation |
SDM College of Dental Sciences and Hospital |
| Address |
Department of Public health Dentistry,SDM College of Dental Sciences and Hospital, Sattur, Dharwad-580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9449834722 |
| Fax |
|
| Email |
sonagajanan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K V V Prasad |
| Designation |
Professor |
| Affiliation |
SDM College of Dental Sciences and Hospital |
| Address |
Department of Public Health Dentistry, SDM College of Dental Sciences and Hospital, Sattur, Dharwad-580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9886305999 |
| Fax |
|
| Email |
kakarlap@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sona G Therathil |
| Designation |
Post Graduate Student |
| Affiliation |
SDM College of Dental Sciences and Hospital |
| Address |
Department of Public Health Dentistry, SDM College of Dental Sciences and Hospital, Sattur, Dharwad-580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9449834722 |
| Fax |
|
| Email |
sonagajanan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Dental Sciences and Hospital, Sattur, Dharwad-580009 |
|
|
Primary Sponsor
|
| Name |
Sona G Therathil |
| Address |
Room No 22, Kanya Kumari Hostel, SDM College of Dental Sciences and Hospital, Sattur, Dharwad-580009, Karnataka |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 |
| Sona G Therathil |
SDM College of Dental Sciences and Hospital |
Department of Public Health Dentistry, SDM College of Dental Sciences and Hospital, Sattur, Dharwad-580009, Karnataka
Dharwad
KARNATAKA |
9449834722
sonagajanan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMCDSH-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
K02 : Dental Caries
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Silver Diamine Flouride 38% |
38% Silver Diamine Fluoride is topically applied on the carious surface using a microbrush once only at baseline.
Manufactured by FAgamin, Tedequim S.R. L., Cordoba, Argentina.
Cariostatic Agent |
| Intervention |
Silver Nitrate solution 25% |
25% Silver nitrate will be topically applied on the carious surface using a microbrush followed by varnish application once only at baseline
Made from Silver nitrate 99% M.W:169.87 (Blulux, Faridabad, India)
Cariostatic |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with deciduous teeth between the ages of 3 and 6 years
2.Children whose parents/guardians have given consent
3.Children who have at least two occlusal carious lesions extending to the dentine on clinical examination
|
|
| ExclusionCriteria |
| Details |
1.Uncooperative children
2.Handicapped children
3.Children with any systemic debilitating diseases
4.Children undergoing orthodontic treatment
5.Children with any severe form of oral diseases
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Arrested Carious Lesions |
at the time of application, after 3 months and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Continuation of Caries |
after 3 months and 6 months of application |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2022 |
| Date of Study Completion (India) |
30/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
|
The aim of this study is to compare the effectiveness of two caries arrest products 1. 38% Silver
Diamine fluoride 2.25% Silver Nitrate and 5% Sodium Fluoride This research is a Randomized parallel two cell design. Subjects who fulfill the inclusion criteria will be randomly divided into
two groups. After obtaining consent Group A will be treated with 38% Silver
Diamine fluoride and Group B will be treated with 25% Silver Nitrate and 5% Sodium Fluoride using
a micro applicator brush while protecting the surrounding soft tissue with
cotton. The outcome variable, caries arrest, will be checked immediately after the application, after 3 month and 6 months using visual and tactile method.
Mann Whitney test will be used to check the statistical significance of the effectiveness of the two products
|
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