| CTRI Number |
CTRI/2024/08/071874 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation and correlation of
human salivary biomarker levels before and after application of topical fluoride agents in children with early childhood caries |
|
Scientific Title of Study
|
Evaluation and correlation of salivary matrix metalloproteinase 8 levels before and after application of MI varnish 38 percent silver diamine fluoride and nano silver fluoride in children with early childhood caries an in vivo 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 pediatric and preventive dentistry
Rajarajeswari dental college and hospital
NO 14 ramohalli cross, mysore road,bengaluru, karnataka 560074
Bangalore KARNATAKA 560074 India |
| Phone |
7624908255 |
| 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 pediatric and preventive dentistry
Rajarajeswari dental college and hospital
NO 14 ramohalli cross, mysore road,bengaluru, karnataka560074
Bangalore KARNATAKA 560074 India |
| Phone |
9880038038 |
| 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 pediatric and preventive dentistry
Rajarajeswari dental college and hospital
NO 14 ramohalli cross, mysore road,bengaluru, karnataka 560074
Bangalore KARNATAKA 560074 India |
| Phone |
7624908255 |
| Fax |
|
| Email |
ganavinayak18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari dental college and hospital
NO 14 ramohalli cross,mysore road,bengaluru,karnataka 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Ganavi G Nayak |
| Address |
Department of pediatric and preventive dentistry
Rajarajeswari dental college and hospital
NO 14 ramohalli cross,mysore road,bengaluru, karnataka 560074 |
| Type of Sponsor |
Other [Self funded ] |
|
|
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
Room number 5
Number 14 ramohalli cross, mysore road Bangalore KARNATAKA |
7624908255
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 |
| Comparator Agent |
salivary matrix metalloproteinase- 8 levels |
Intragroup evaluation and correlation of salivary matrix metalloproteinase-8 levels before and after one month and three month topical application of MI varnish( group 1) on primary carious teeth in children with early childhood caries
|
| Comparator Agent |
Salivary matrix metalloproteinase-8 levels |
Intergroup evaluation and correlation of salivary matrix metalloproteinase-8 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 matrix metalloproteinase-8 levels |
Intragroup evaluation and correlation of salivary matrix metalloproteinase-8 levels before and after one month and three month topical application of 38% silver diamine fluoride ( group 2) on primary carious teeth in children with early childhood caries.
|
| Comparator Agent |
Salivary matrix metalloproteinase-8 levels |
Intragroup evaluation and correlation of salivary matrix metalloproteinase-8 levels before and after one month and three month topical application of nano silver fluoride ( group 3) on primary carious teeth in children with early childhood caries. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with 3 to 6 years of age of both the 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 MMP-8 levels before and after application of MI varnish, 38% SDF and NSF in children with ECC using ELISA.
|
Base line
1 month
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation & comparision of intragroup & intergroup salivary MMP- 8 levels before & after application of MI varnish, 38% SDF & NSF in children with ECC using ELISA |
Base line
1 month
3 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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 inclusion criteria will be selected and divided into three experimental groups, 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 minutes . Then these tubes will be sealed immediately after sample collection and refigerated at - 20 degree celsius and stored in laboratory until further analysis. Group 1 - MI varnish, Group 2- 38% SDF , Group 3 -NSF will be applied on selected carious teeth with micro brush and left for 2 minutes . Post application instructions will be given. Patients will be recalled after 1 month and 3 month and post- interventional unstimulated salivary samples will be collected by the same procedure as mentioned above. All samples will be subjected to ELISA to evaluate and compare salivary MMP- 8 levels. Results obtained will be subjected to statistical data. |