| CTRI Number |
CTRI/2024/12/078741 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Is fluoride varnish(topical fluoride agent) effective in caries prevention among adults |
|
Scientific Title of Study
|
Effectiveness of Fluoride varnish in adjunct to Oral health education in caries prevention among prisoners of Haryana. A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanupriya Pandey |
| Designation |
Postgraduate Student |
| Affiliation |
Postgraduate Institute of Dental Sciences, Rohtak |
| Address |
Room No 14 Department of Public Health Dentistry, Postgraduate Institute of Dental Sciences, Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
09899127203 |
| Fax |
|
| Email |
kanupriyapandey2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adarsh Kumar |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Dental Sciences, Rohtak |
| Address |
Room No 14 Department of Public Health Dentistry, Postgraduate Institute of Dental Sciences, Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9468110075 |
| Fax |
|
| Email |
adarsh.pgids@uhsr.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanupriya Pandey |
| Designation |
Postgraduate Student |
| Affiliation |
Postgraduate Institute of Dental Sciences, Rohtak |
| Address |
Room No 14 Department of Public Health Dentistry, Postgraduate Institute of Dental Sciences, Rohtak Haryana
HARYANA
124001
India |
| Phone |
09899127203 |
| Fax |
|
| Email |
kanupriyapandey2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 14 Department of Public Health Dentistry Postgraduate Institute of Dental Sciences Rohtak Haryana 124001 |
| Self funded but applied for the Postgraduate Dissertation Support Grant |
|
|
Primary Sponsor
|
| Name |
Dr Kanupriya Pandey |
| Address |
Department of Public Health Dentistry, PGIDS Rohtak |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rajender Singh |
District Jail Sonipat |
Police line Colony Sonipat Haryana 131001
Rohtak
HARYANA |
9416630759
supdtsnp.jail@hry.nic.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Biomedical And Health Research Ethics Committee |
Approved |
| Biomedical And Health Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluoride varnish application |
Experimental Group (Group 2 or Fluoride Varnish with Oral Health Education group): The participants will get oral health as outlined for Group 1 as well as professional application of 5% sodium fluoride varnish semi-annually. For oral health education, they will receive a questionnaire regarding knowledge attitude, and practice which will be followed by a standardized oral health education session of about 20 to 30 minutes. Posters and charts will be used for the same. Participants will be encouraged to ask questions. A tooth brushing demonstration will be done using a brushing model and a toothbrush. To reinforce this a poster will be displayed on the premises of the jail. The dentist will use cotton to remove any extra saliva, clean, dry, and isolate the patients teeth using cotton rolls. Following that, using a disposable brush, the dentist will apply a 5% fluoride varnish to all of the patients tooth surfaces, and afterward, they will leave it on for one minute. The participants will be told to close their mouths to enable the varnish to dry out after application. They will be told not to brush until the following day and not to consume anything rough (abrasive) for the rest of the day |
| Comparator Agent |
Oral health Education as compararator |
Control Group (Group 1 or Oral Health Education): Following recruitment, the participants will receive a questionnaire regarding knowledge attitude, and practice which will be followed by a standardized oral health education session of about 20 to 30 minutes. Posters and charts will be used for the same. Participants will be encouraged to ask questions. A tooth brushing demonstration will be done using a brushing model and a toothbrush. To reinforce this a poster will be displayed on the premises of the jail. Subsequent appointments will be scheduled at 1 month, 6 months until the end of the follow-up period. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. A minimum of 3 years of sentence remaining.
2.Age 35-50 years
3. Belonging to Male gender |
|
| ExclusionCriteria |
| Details |
1. Less than 20 teeth
2. with systemic conditions that directly increase the risk of caries
3.with less than three years remaining on their sentence as of the trial’s start date. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Net caries increments
Caries preventive fraction
knowledge, attitude, and practice
|
one year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
oral hygiene status and oral hygiene knowledge
cost-effectiveness of implementing fluoride varnish application
Change in Oral health related Quality of Life
Any Side Effects
Patient Acceptability
|
one year |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The effectiveness of fluoride varnish in preventing caries in adults is still not known clearly. Recommendations for topical fluoride use are based on expert opinion, extrapolating the evidence from permanent teeth of children and adolescents so very few studies exist in adults. Our study will be conducted to fill this critical gap in the use of fluoride varnish in adults particularly those at high risk of developing dental caries.Aim of the study is to find out the effectiveness of fluoride varnish with oral health education vs oral health education in the prevention of caries among prisoners of Haryana.A 12-month randomized control trial with a parallel-group design will be conducted in the Jails of Haryana. The participants will be randomly divided into a control group and an experimental consisting of 200 participants each. In group 1 or the control group following recruitment, the participants will receive a questionnaire regarding knowledge attitude, and practice which will be followed by a standardized oral health education session of about 20 to 30 minutes. Posters and charts will be used for the same. Participants will be encouraged to ask questions. A tooth brushing demonstration will be done using a brushing model and a toothbrush. To reinforce this a poster will be displayed on the premises of the jail. Subsequent appointments will be scheduled at 1 month, 6 months until the end of the follow-up period. In the experimental group or Fluoride Varnish with Oral Health Education group, the participants will get oral health as outlined for Group 1 as well as professional application of 5% sodium fluoride varnish semi-annually. For oral health education, they will receive a questionnaire regarding knowledge attitude, and practice which will be followed by a standardized oral health education session of about 20 to 30 minutes. Posters and charts will be used for the same. Participants will be encouraged to ask questions. A tooth brushing demonstration will be done using a brushing model and a toothbrush. To reinforce this a poster will be displayed on the premises of the jail and Subsequent appointments will be scheduled at 1 month, 6 months until the end of the follow-up period. The dentist will use cotton to remove any extra saliva, clean, dry, and isolate the patient’s teeth using cotton rolls. Following that, using a disposable brush, the dentist will apply a 5% fluoride varnish to all of the patient’s tooth surfaces, and afterward, they will leave it on for one minute. The participants will be told to close their mouths to enable the varnish to dry out after application. They will be told not to brush until the following day and not to consume anything rough (abrasive) for the rest of the day. Oral Health related Quality of Life will be assessed using OHIP-14
|