| CTRI Number |
CTRI/2023/02/050056 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between fluoride varnish and fluoride containing mouth rinse among 12yrs old school going children of Lucknow city |
|
Scientific Title of Study
|
Comparative evaluation between fluoride varnish and fluoride containing mouth rinse amongst 12yrs old school going children of Lucknow city:field 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 Pratisha Mishra |
| Designation |
MDS 1st year |
| Affiliation |
Sardar patel postgraduate institute of dental and medical sciences, lucknow |
| Address |
Dept of public health dentistry
Sardar patel postgraduate institute of dental and medical sciences, lucknow
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
08763654770 |
| Fax |
|
| Email |
pratishamishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja M Sinha |
| Designation |
reader |
| Affiliation |
Sardar patel postgraduate institute of dental and medical sciences, lucknow |
| Address |
Dept of public health dentistry
Sardar patel postgraduate institute of dental and medical sciences, lucknow
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
9453014043 |
| Fax |
|
| Email |
dr.pujasinha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratisha Mishra |
| Designation |
MDS 1st year |
| Affiliation |
Sardar patel postgraduate institute of dental and medical sciences, lucknow |
| Address |
Dept of public health dentistry
Sardar patel postgraduate institute of dental and medical sciences, lucknow
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
08763654770 |
| Fax |
|
| Email |
pratishamishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| sardar patel postgraduate institute of dental and medical sciences, lucknow |
|
|
Primary Sponsor
|
| Name |
dr pratisha mishra |
| Address |
Sardar Patel Postgraduate Institute of Dental and Medical Sciences,
Chaudhary Vihar, Raebareli Road, Lucknow,226029
|
| 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 |
| dr pratisha mishra |
lucknow |
bright star convent school,uttarathia, lucknow
Lucknow
UTTAR PRADESH |
8763654770
pratishamishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
school going children
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fluoride containing mouth rinse |
fluoride varnish application would be done in group1 and fluoride containing mouth rinse is given to the other group.the the caries preventive effect would be compared between the two fluoride agent. |
| Intervention |
topical fluoride application |
fluoride varnish application would be done in group1 and fluoride containing mouth rinse is given to the other group.the the caries preventive effect would be compared between the two fluoride agent. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1)Study subjects aged 12 years with the highest risk of developing caries (WHO basic classification for dental caries scale for assessing occlusal surfaces of teeth not more than D2)6 .
2) Study subjects whose parents will give consent.
3) Study subjects willing to participate
|
|
| ExclusionCriteria |
| Details |
• Subjects complaining of pain and sensitivity due to deep carious lesion.
• Subjects with orthodontic bands or under any other dental treatment.
• Subjects with special health care needs (Physically handicapped children).
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The fluoride varnish and fluoride containing mouth rinse will act as preventive agent for dental caries which will arrest the caries progression and would prevent further tooth decay.fluoride containing mouth rinse would be costeffective.however, fluoride varnish will be more effective in comparison to mouth rinse. |
The fluoride varnish and fluoride containing mouth rinse will be applied at base line and it would act as preventive agent for dental caries at 3months, 6months and 9months respectively which will arrest the caries progression and would prevent further tooth decay. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To recommend any of the above methods for caries prevention in 12 years old school going children at 3months, 6months and 9months |
To recommend any of the above methods for caries prevention in 12 years old school at the end of 9months going children. |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="230" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2023 |
| Date of Study Completion (India) |
27/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/11/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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)?
Response - NO
|
Brief Summary
Modification(s)
|
“Heath is a state of complete physical, mental, social well being and not merely the absence of disease and infirmity†by WHO. The oral disorder can have a negative impact on the functional social and psychological well-being of children and their families. Dental caries is considered a public health problem worldwide due to the high prevalence, economic impact, and the possibility of prevention. In India dental caries afflicts more than 50% of the subjects in all subjects groups varing from 51.9% to 85% and the mean prevalence rate of dental caries was found to be 48% in 12 years old children.1,2 Targeting preventive strategies for preventing dental caries in school set up will go in long way to decrease the future burden of the disease and to improve oral and general health related quality of life in school going children.2 School can provide an effective platform for promoting oral health because they reach 1 billion worldwide.3 Fluoride has been used as a powerful tool time and again to prevent and control dental caries. Fluoride varnish provides an opportunity to offer professionally applied topical applied in schools. Numerous studies have quoted that Biannually application of Fluoride varnish is effective in preventing dental caries in permanent dentition.4 School based fluoride mouth rinse program have been considered as important low cost strategy to prevent caries among school children.5 The efficacy of fluoride varnish that varies from 25-80% whereas that of fluoride mouth rinse was 30%.2 both have been shown effective in community as well as individual basis. |