| CTRI Number |
CTRI/2017/11/010543 [Registered on: 17/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Anticaries role of silver diamine fluoride and fluoride varnish in children |
|
Scientific Title of Study
|
Clinical study of antibacterial antiplaque and anticaries effects of silver diamine fluoride and fluoride varnish in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saloni verma |
| Designation |
Post graduate student |
| Affiliation |
Maharashi Markandeshwar College of Dental Sciences and Research |
| Address |
Department of pediatric and preventive dentistry
Maharashi Markandeshwar College of Dental Sciences and Research
Maharashi Markandeshwar University
Mullana
Ambala
HARYANA
133207
India |
| Phone |
8059265344 |
| Fax |
|
| Email |
drsaloni.verma668.dv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HP Suma Sogi |
| Designation |
Professor and Head |
| Affiliation |
Maharashi Markandeshwar College of Dental Sciences and Research |
| Address |
Department of pediatric and preventive dentistry
Room number 4
Maharashi Markandeshwar College of Dental Sciences and Research
Maharashi Markandeshwar University
Mullana
Ambala
HARYANA
133207
India |
| Phone |
8059930475 |
| Fax |
|
| Email |
hpsumasogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saloni verma |
| Designation |
Post graduate student |
| Affiliation |
Maharashi Markandeshwar College of Dental Sciences and Research |
| Address |
Department of pediatric and preventive dentistry
Room number 4
Maharashi Markandeshwar College of Dental Sciences and Research
Maharashi Markandeshwar University
Mullana
Ambala
HARYANA
133207
India |
| Phone |
8059265344 |
| Fax |
|
| Email |
drsaloni.verma668.dv@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self sponsored |
| Address |
Maharashi Mrkandeshwar College of Dental Sciences and Research |
| 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 |
| Saloni verma |
Department of Pediatric and Preventive Dentistry |
Department of pediatric and preventive dentistry
Room number 4
Maharashi Markandeshwar College of Dental Sciences and Research
Ambala
HARYANA |
8059265344
drsaloni.verma668.dv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dental Caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group of 12-14 years
2. All permanent teeth fully erupted except third molar
3. Children with DMFT between 2-5
4. Decayed Missing Filled teeth more than two and less than five by ICDAS criteria
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised children
2. Children having ulcerative gingivitis or stomatitis
3. Children with any physical limitations which preclude the children not to participate in this study
4. Children with known silver allergy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the antiplaque, antibacterial and anticaries effect of Silver Diamine Fluoride and Fluoride varnish in 12 to 14 year old children |
Plaque index score and Streptococcus mutans count at 72 hours, 3 months and 6 months
Dental caries occurance after 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect on dental caries occurence after application of Silver Diamine Fluoride and Fluoride varnish |
At Baseline, 6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2 |
|
Date of First Enrollment (India)
|
11/05/2017 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dental caries is
the multifactorial disease. Silver Diamine Fluoride is an inexpensible
medicament applied topically for the treatment of dental caries. Topical
application of Silver Diamine Fluoride
has gained much attention in the past decade this may be due to ease of
application and low cost of Silver Diamine Fluoride. SDF can arrest the development of caries in
the deciduous dentition and prevent caries in first permanent molars . The aim of the
present study is to evaluate the antibacterial,
antiplaque and anticaries
effects of silver diamine fluoride and fluoride varnish in children and objectives are as follows To
To compare placebo (normal saline) controled effects of clinical application of
silver diamine fluoride (SDF) and Fluoride varnish on , plaque index score and
salivary microbial count (CFU), using selective media for streptococcus mutans
at 72 hours, 3 months and 6 months in 12-14 years old pediatric patients.
To
To study and compare effect on dental caries occurance after 6 months and 12
months of application of Silver Diamine Fluoride and fluoride varnish using ICDAS
criteria.
To To study and
compare the role of Silver Diamine Fluoride in reducing cariogenic microflora
and its use in caries prevention. To To
establish the role of fluoride in reducing cariogenic microflora and its uses
in caries prevention.
|