| CTRI Number |
CTRI/2021/04/032480 [Registered on: 01/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING THE EFFECTIVENESS OF NANO SILVER
FLUORIDE VARNISH AND SILVER DIAMINE FLUORIDE VARNISH
IN HALTING DENTAL DECAY PROGRESSION AMONG ANGANWADI
CHILDREN OF MANGALORE |
|
Scientific Title of Study
|
COMPARISON OF THE EFFECTIVENESS OF NANO SILVER
FLUORIDE VARNISH AND SILVER DIAMINE FLUORIDE VARNISH
IN ARRESTING DENTAL CARIES AMONG ANGANWADI
CHILDREN OF MANGALORE: A RANDOMIZED CONTROL TRAIL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshni R S |
| Designation |
PG student |
| Affiliation |
A J Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
A J Institute of Dental Sciences,
NH-66, Kuntikana, Mangalore
A J Institute of Dental Sciences,
NH-66, Kuntikana, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9442654301 |
| Fax |
|
| Email |
roshnirs1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja J Shetty |
| Designation |
Reader |
| Affiliation |
A J Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
A J Institute of Dental Sciences,
NH-66, Kuntikana, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9945859024 |
| Fax |
|
| Email |
shettypoojaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja J Shetty |
| Designation |
Reader |
| Affiliation |
A J Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
A J Institute of Dental Sciences,
NH-66, Kuntikana, Mangalore
Tiruchirappalli
KARNATAKA
575004
India |
| Phone |
9945859024 |
| Fax |
|
| Email |
shettypoojaj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Roshni R S |
| Address |
5 278 B, Mathilagam, Nalloor, Marthandam, Kanyakumari District, Tamilnadu |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Bhavya |
Anganwadi centre |
Kallapu cross road,
Near nethravathi bridge,
Adamkudra,
Mangalore
Dakshina Kannada
KARNATAKA |
9481772525
bhavyak9876@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A J Institute of Medical Sciences and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Caries Prevention and Arrest |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
38% Silver diamine fluoride varnish |
Thorough oral prophylaxis will be done. Isolation will be done using cotton rolls. Initial cleaning of cavity would be performed by using cotton pellets. 1)Standard personal protective equipment is used for patient and provider. 2)One drop of varnish will be taken into a plastic dappen dish.  3)Tongue and cheek will be isolated from affected teeth with cotton rolls.  4)If near the gingiva, petroleum jelly will be applied for safety. 5)Indicated tooth surfaces will be dried with cotton. 6)Micro applicator tip is bent, immersed into varnish and excess removed on side of dappen dish. 7)Silver diamine fluoride varnish will be directly applied onto the indicated tooth surface(s) with micro applicator tip for 10 seconds. 8)Varnish is allowed to absorb for up to one minute, then excess is removed with cotton 9)The cavity will be closed with a cotton pellet for 10 minutes. 10)The child will be instructed not to drink or eat food for at least 45 minutes. 11) Gloves, cotton and micro applicator tips will be discarded in plastic bag and disposed by appropriate method. |
| Intervention |
5% Nano silver fluoride |
Thorough oral prophylaxis will be done.
Isolation will be done using cotton rolls.
Initial cleaning of cavity would be performed by using cotton pellets.
1)Standard personal protective equipment is used for patient and provider.
2)One drop of varnish will be taken into a plastic dappen dish. 
3)Tongue and cheek will be isolated from affected teeth with cotton rolls. 
4)If near the gingiva, petroleum jelly will be applied for safety.
5)Indicated tooth surfaces will be dried with cotton.
6)Micro applicator tip is bent, immersed into varnish and excess removed on side of dappen dish.
7)Nano silver fluoride varnish will be directly applied onto the indicated tooth surface(s) with micro applicator tip for 10 seconds.
8)Varnish is allowed to absorb for up to one minute, then excess is removed with cotton
9)The cavity will be closed with a cotton pellet for 10 minutes.
10)The child will be instructed not to drink or eat food for at least 45 minutes.
11) Gloves, cotton and micro applicator tips will be discarded in plastic bag and
disposed by appropriate method.
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
4.00 Year(s) |
| Gender |
Both |
| Details |
1) Be aged 3 - 4 years.
2) Have parental consent
3) Should have at least 1 tooth with untreated active carious lesion(s), extending into the dentin at baseline examination.
|
|
| ExclusionCriteria |
| Details |
1) Children who are uncooperative and difficult to manage.
2) Children with carious lesions involving the pulp on clinical examination.
3) Children with medical history of systemic disease, physical or mental disabilities.
4) Children with history of Silver allergy.
5) Children with ulceration in oral cavity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Arrest of dental caries |
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between nano silver fluoride varnish and silver diamine fluoride varnish in arresting dental caries |
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2021 |
| Date of Study Completion (India) |
31/10/2021 |
| 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
|
Will be applying for publication after the completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to assess and compare the effectiveness of 5% Nano silver diamine fluoride and 38% Silver diamine fluoride in arresting dental caries among Anganwadi children of Mangalore
It is a randomized, parallel, single blinded trail. Anganwadi centers close to the research institute will be selected based on convenience and the centres will be randomized into two groups based on computer generated randomization. Subjects who fulfill the inclusion criteria will be recruited in the study. After obtaining consent baseline data will be collected using Nyvad’s criteria. Then in Group A: oral prophylaxis and application of 5% nano silver fluoride varnish will be done and in Group B: Oral prophylaxis and application of 38% Silver Diamine fluoride varnish will be done.
The outcome variable, the arrest of dental caries will be assessed during followup using Nyvad’s criteria at 3 months and 6 months interval.
Data will be entered in the excel spreadsheet. Descriptive statistics will be obtained. Repeated measures of Analysis of Variance will be used for analysis of data if the data is normally distributed. Any other necessary tests will be dealt at the time of analysis based on data distribution. the level of significance will be set as 0.05.
|