| CTRI Number |
CTRI/2025/08/093441 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of Sodium Fluoride varnish in adjunction with Chlorhexidine or Povidone iodine versus Sodium Fluoride varnish alone for caries prevention in 12-year olds: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effectiveness of Sodium Fluoride varnish in adjunction with
Chlorhexidine or Povidone iodine versus Sodium Fluoride varnish alone
for caries prevention in 12-year olds: 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 |
Abhishek |
| Designation |
Post Graduate Student |
| Affiliation |
Post Graduate Institute of Dental Sciences,Rohtak |
| Address |
Department of Public Health Dentistry, Post Graduate Institute of Dental Sciences, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8397974518 |
| Fax |
|
| Email |
abhishekbhargav369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Adarsh Kumar |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Dental Sciences,Rohtak |
| Address |
Department of Public Health Dentistry, Post Graduate Institute of Dental Sciences,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8397974518 |
| Fax |
|
| Email |
adarsh.pgids@uhsr.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek |
| Designation |
Post Graduate Student |
| Affiliation |
Post Graduate Institute of Dental Sciences,Rohtak |
| Address |
Department of Public Health Dentistry, Post Graduate Institute of Dental Sciences,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8397974518 |
| Fax |
|
| Email |
abhishekbhargav369@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhishek |
| Address |
Department of Public Health Dentistry, Post Graduate Institute of Dental Sciences, Rohtak
Haryana- 124001 |
| 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 Abhishek |
Post Graduate Institute of dental sciences |
Room no. 14, Department of Public Health Dentistry
Rohtak
HARYANA |
8397974518
abhishekbhargav369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical and Health Research Ethics Committee,PGIDS,Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10% Povidone Iodine and 5% Chlorhexidine |
Around 0.3 ml of 10% Povidone Iodine and same amount of Chlorhexidine will be used at once in 6 months and will be applied 3 times in 18 months topically on tooth surface. |
| Comparator Agent |
5% Sodium Fluoride varnish |
Around 0.3 ml of 5% Sodium Fluoride varnish will be used at once in 6 months and will be applied 3 times in 18 months topically on tooth surface. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
I. Persons willing to participate.
II. Participants living in the same area since birth.
III. At least 16 teeth are present.
IV. Coronal caries with ICDAS score equal to or less than 3. |
|
| ExclusionCriteria |
| Details |
(I) Participants with systemic disorders.
(II) Participants not giving consent. (III) Uncooperative participants. (IV) Hypoplastic teeth. (V) Patients with severe gingivitis, or other conditions where maintenance of oral
hygiene is not possible. (VI) Participants undergoing orthodontic treatment. (VII) Participants taking any active treatment. (VIII) Participants who took antibiotic drugs in the last 1 month. (IX) Participants involved in any other trial. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(I) Net caries increment assessed by subtracting the number of
reversed or remineralized lesions from the total number of new lesions recorded at follow- up. Active lesions will only be considered |
(ii) S. mutans Bacterial colony
count |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| (ii)Streptococcus Mutans colony count at first & second follow up |
At 6 & 12 months after baseline |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="6"
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
|
Dental caries is most common chronic non- communicable disease affecting 3.5 billion people worldwide. Many strategies have been practiced to check the progression of dental caries out of which fluoride use is most common. A newer strategy involving use of an antibacterial agent along with fluoride agent. Chlorhexidine and povidone iodine are common antibacterial agents used in dentistry. This clinical trial aims to compare the efficiency of fluoride varnish in adjunction with chlorhexidine or povidone iodine in comparison with sodium fluoride varnish alone. |