| CTRI Number |
CTRI/2020/11/029210 [Registered on: 18/11/2020] Trial Registered Prospectively |
| Last Modified On: |
21/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessing Benefits Of Treatment Of Dental Caries Using 38% Silver Diamine Fluoride And Placebo Among Primary School Children In Hyderabad City: A Randomized Controlled Trial. |
|
Scientific Title of Study
|
Effectiveness Of 38% Silver Diamine Flouride In Arresting Caries With A Placebo Among Primary School Children In Hyderabad City: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shravya Deverashetty |
| Designation |
MDS |
| Affiliation |
Panineeya Institute of Dental Sciences |
| Address |
Department of public health dentistry, Room no 201, Panineeya Institute of Dental Sciences, Hyderabad.
Road No 5, Kamala nagar, Dilsukhnagar, Kothapet, Hyderabad - 500060
Hyderabad
TELANGANA
500047
India |
| Phone |
9052804847 |
| Fax |
|
| Email |
shravyadeverashetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padma Reddy |
| Designation |
MDS |
| Affiliation |
Panineeya Institute of Dental Sciences |
| Address |
Department Of Public Health Dentistry, Room No 201,Panineeya Institute Of dental Sciences, Hyderabad.
Road no 5, Kamalanagar, Dilsukhnagar, Kothapet, Hyderabad - 500060
Hyderabad
TELANGANA
500047
India |
| Phone |
9052804847 |
| Fax |
|
| Email |
drprphd07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srilatha |
| Designation |
MDS |
| Affiliation |
PANINEEYA INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Public Health Dentistry, room no 201,panineeya institute of dental sciences, HYDERABAD
department of public health dentistry, room no 201,panineeya institute of dental sciences, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9052804847 |
| Fax |
|
| Email |
phdpani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indiamart, AKV Enterprises ,Baghlingampally, Hyderabad ,telangana |
|
|
Primary Sponsor
|
| Name |
H Sai Sandeep |
| Address |
3-16-97/5/4, Venkat Reddy Nagar, Ramanthapur, Hyderabad. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| M PADMA REDDY |
PANINEEYA DENTAL COLLEGE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| D Shravya |
zilla Primary Parishad School |
room no 6,primary department, zilla parishad primary school,karmanghat, L.B nagar,saroornagar,rangareddy.
Hyderabad
TELANGANA |
9052804847
shravyadeverashetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE OF PANINEEYA INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
DENTAL CARIES |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
38% silver diamine fluoride |
Flouride liquid applied through brush on the primary molars ,left for a minute . |
| Comparator Agent |
Placebo |
On primary molars |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children having at least one untreated cavitated active caries lesion based on Nyvad criteria.[code :3 Enamel/dentin cavity easily visible with the naked eye; surface of cavity feels soft or leathery on gentle probing ]
ï‚¢ Parents who gave written informed consent . |
|
| ExclusionCriteria |
| Details |
Children not willing to participate in the study
ï‚¢ Presence of any gingival or perioral ulceration or stomatitis or presence of a tooth abscess. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caries arrest |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inhibits caries progression |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/11/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Untreated dental caries is a global
pandemic. Due to limited financial resources, poor access to basic oral care,
and the high cost of restorative treatment, children of low-income nations
have their general health, social well-being, and education opportunities
affected by untreated dental caries .
- In this context, there is interest in simple treatments to halt
progress of cavities (caries lesions) after tooth decay onset .
Arresting Caries Treatment (ACT) has been
proposed to manage untreated dental caries in children of disadvantaged
communities.
- Topical silver diamine fluoride
is a clear liquid that is painted on the active lesion surface in
milligram amounts and arrests the lesion.
- Cleared by the Food and
Drug Administration in 2014 as a treatment for sensitive teeth and used
off-label for the treatment of
cavities in the United States since 2015,12 clinical trials outside the United States have
documented caries arrest.
- Silver diamine fluoride (SDF) treatment has been identiï¬ed as a
potential solution to address the dental public health issues of
untreated dental caries and insufï¬cient access to care especially among
disadvantaged children.
- The current study will assess the short term effectiveness
of 38 percent SDF in arresting
active caries lesions in children.
|
·
The Aim of this randomized
controlled trial was to investigate and compare the short term
effectiveness of topically applied 38%
silver diamine fluoride with a placebo in arresting caries lesions in primary
school children in Hyderabad city.
A
randomized controlled trial will be carried out among 61 Primary school children in
Hyderabad city. The caries status of the children will be assessed using Nyvad
criteria (1999), wherein children with score 3 of Nvyad criteria will be included in the study. The
children will be randomly assigned to Active Group (n=31) and Control Group (n=30).
The Active group will receive topical
application of 38% SDF and the control group receives topical application of
sterile water as ( placebo). Examination of caries lesions will be assessed at Baseline
and after 21st day. On 21st day the number of lesions that are arrested will be evaluated based on the score 6 of Nyvad criteria.
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