| CTRI Number |
CTRI/2025/05/087691 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dentistry] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effect of topical fluorides on salivary bacteria streptococcus mutans levels and salivary pH in children with early childhood caries
|
|
Scientific Title of Study
|
Comparing the effect of MI varnish, 38% silver diamine fluoride and nano silver fluoride on salivary streptococcus mutans levels and salivary pH in children with early childhood caries an invivo study
|
| 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 Ganavi G Nayak |
| Designation |
Post graduate student |
| Affiliation |
Rajarajeswari dental college and hospital bengaluru |
| Address |
Department of pedodontics and preventive dentistry, Rajarajeswari dental college and hospital
number 14, ramohalli cross,mysore road,Bengaluru,Karnataka 5600074
Department of pedodontics and preventive dentistry, Rajarajeswari dental college and hospital
number 14 ,ramohalli cross, mysuru road , Bangaluru 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
07624908255 |
| Fax |
|
| Email |
ganavinayak18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya A R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari dental college and hospital bengaluru |
| Address |
Department of pedodontics and preventive dentistry, Rajarajeswari dental college and hospital, number 14, ramohalli cross, mysore road, Bengaluru
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
09880038038 |
| Fax |
|
| Email |
jaya.vrushabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganavi G Nayak |
| Designation |
Post graduate student |
| Affiliation |
Rajarajeswari dental college and hospital bengaluru |
| Address |
Department of pedodontics and preventive dentistry, Rajarajeswari dental college and hospital,number 14, ramohalli cross, mysore road, Bengaluru
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
07624908255 |
| Fax |
|
| Email |
ganavinayak18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pedodontics and preventive dentistry, Rajarajeswari dental college and hospital
Number 14, Ramohalli cross,Mysore road,Bengaluru,Karnataka 5600074 |
|
|
Primary Sponsor
|
| Name |
Dr Ganavi G Nayak |
| Address |
Department of pedodontics and preventive dentistry, Rajarajeswari dental college and hospital
Number 14, Ramohalli cross,Mysore road,Bengaluru,Karnataka 5600074 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ganavi G Nayak |
Rajarajeswari dental college and hospital |
Department of pedodontics and preventive dentistry, Rajarajeswari dental college and hospital
Number 14, Ramohalli cross,Mysore road,Bengaluru,Karnataka 5600074
Bangalore Rural
KARNATAKA |
07624908255
ganavinayak18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
salivary streptococcus mutans and salivary pH levels |
Intergroup evaluation and correlation of salivary streptococcus mutans and salivary pH levels before and after one month and three month topical application of MI varnish,38% silver diamine fluoride and nano silver fluoride on primary carious teeth in children with early childhood caries |
| Comparator Agent |
salivary streptococcus mutans and salivary pH levels |
Intragroup evaluation and correlation of salivary streptococcus mutans and salivary pH levels before and after one month and three month topical application of 38% silver diamine fluoride ( group2) on primary carious teeth in children with early childhood caries. |
| Comparator Agent |
salivary streptococcus mutans and salivary pH levels |
Intragroup evaluation and correlation of salivary streptococcus mutans and salivary pH levels before and after one month and three month topical application of MI varnish ( group1) on primary carious teeth in children with early childhood caries. |
| Comparator Agent |
salivary streptococcus mutans and salivary pH levels |
Intragroup evaluation and correlation of salivary streptococcus mutans and salivary pH levels before and after one month and three month topical application of nano silver fluoride ( group3) on primary carious teeth in children with early childhood caries. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Day(s) |
| Age To |
6.00 Day(s) |
| Gender |
Both |
| Details |
1.Children with 3 to 6 years of age of both genders
2.Children with DC greater than or equal to 3 in primary teeth, ICDAS II criteria , CODE 02 and 03
3. Parents giving consent for the study |
|
| ExclusionCriteria |
| Details |
1. Children who received fluoride topical application during the last 1 month
2. Children requiring special health care needs.
3.Pulpally involved and grossly decayed teeth.
4.Children who were on antibiotic therapy within the past 3 months.
5.Children with genetic diseases or syndrome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate salivary streptococcus mutans levels and salivary pH before and after application of MI varnish,38% SDF and NSF in children with ECC using ELISA |
Base line
1 month
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation and comparision of intragroup and intergroup salivary streptococcus mutans level and salivary pH levels before and after application of MI varnish,38% SDF and NSF in childrden with ECC using ELISA |
Base line
1 month
3 month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/06/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A total of 45 children who meets the inclusion criteria will be selected for the study and grouped as follows. Group 1 ( n=15), Group 2( n=15), Group 3( n=15). All subjects will be instructed to refrain from eating and drinking for 1 hour before the saliva sample collection. Pre-intervention unstimulated saliva sample will be collected by spitting method. The patients will be asked to rinse the mouth with filter water twice before the collection. After the oral rinse, Children will be asked to spit the saliva into sterile tubes for a period of 5 min. Then, these tubes will be sealed immediately after sample collection and refrigerated at -20 degree Celsius and stored in laboratory until further analysis. Group I children are treated with MI varnish, Group II with 38% SDF and Group III with NSF respectively with micro brush and left for 2minutes.Post application instructions will be given. Children are recalled after 1 month and 3 month from the day of application and post -intervention saliva samples will be collected by same procedure as mentioned above and all the samples are subjected to lab to determine the salivary pH and S.mutans levels. The results obtained will be subjected to statistical analysis. |