| CTRI Number |
CTRI/2018/05/013799 [Registered on: 09/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the relative effectiveness of fissure sealants and fluoride varnish in prevention of occlusal caries in children. |
|
Scientific Title of Study
|
Evaluation of relative effectiveness of fissure sealants and fluoride varnish in prevention of occlusal caries in children A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr THANNA CHETAN |
| Designation |
Post graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of pedodontics and preventive dentistry
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
Andhra Pradesh
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9494343343 |
| Fax |
|
| Email |
chetanthanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrUloopi ks |
| Designation |
professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of pedodontics and preventive dentistry
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
Andhra Pradesh
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9666404455 |
| Fax |
|
| Email |
uloopiks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChaitanyaP |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
Department of pedodontics and preventive dentistry
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
Andhra Pradesh
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9908217142 |
| Fax |
|
| Email |
drchaitanyamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| 3M Clinpro XT varnish
3M Clinpro sealants |
|
|
Primary Sponsor
|
| Name |
Thanna chetan |
| Address |
Department of pedodontics and preventive dentistry
Vishnu Dental College
Vishnupur
Bhimavaram
Andhra Pradesh |
| 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 |
| Thanna Chetan |
Vishnu dental college |
Department of pedodontics and preventive dentistry
Vishnu dental college
Vishnupur
Bhimavaram
West godavari
Andhra pradesh
West Godavari
ANDHRA PRADESH |
9494343343
chetanthanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
deep retentive pit and fissures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3M Clinpro sealant |
pit and fissure sealant |
| Intervention |
3M Clinpro XT varnish |
flouride varnish |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of 6-7 years.
2. Caries free mandibular 1st permanent molars.
3.Willing and co-operative children |
|
| ExclusionCriteria |
| Details |
1. History of systemic illness.
2. Current participation in other studies 3. Hypo plastic tooth / hypo mineralized tooth
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be improvement in the prevention of occlusal caries in children with the use of fluoride varnish |
0 6 12 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be no difference in the prevention of occlusal caries in children with the use of fluoride varnish over sealant |
0 6 12 18 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized
clinical trial study conducted in 100 children of 6-7 years of age in Vishnu
dental college, Bhimavaram, For a period of 18 months, With an aim, to
evaluation the relative effectiveness of fissure sealants and fluoride varnish
in prevention of occlusal caries in children. The primary outcome is there will
be difference in prevention of occlusal
caries in children with the use of varnish when compared with sealant. |