| CTRI Number |
CTRI/2025/07/091199 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of salivary proteins expression and dental caries in diabetic and non-diabetic children with and without topical remineralization therapy |
|
Scientific Title of Study
|
To evaluate and compare aquaporin 5 (AQP-5) salivary flow rate and caries experience in children with type 1 diabetes mellitus and non diabetic children before and after topical remineralizing therapy |
| 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 ABHIRAMI K |
| Designation |
Postgraduate Student |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital Department of Pediatric and Preventive Dentistry No 14 Ramohalli Cross Kumbalgodu Mysore Road Bangalore 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
8553085507 |
| Fax |
|
| Email |
dr.abhiramik7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAYA A R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital Department of Pediatric and Preventive Dentistry No 14 Ramohalli Cross Kumbalgodu Mysore Road Bangalore 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9880038038 |
| Fax |
|
| Email |
jaya.vrushabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHIRAMI K |
| Designation |
Postgraduate Student |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital
Department of Pediatric and Preventive Dentistry
No 14 Ramohalli Cross Kumbalgodu Mysore Road Bangalore 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
08553085507 |
| Fax |
|
| Email |
dr.abhiramik7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College and Hospital Department of Pediatric and Preventive Dentistry No 14 Ramohalli Cross Kumbalgodu Mysore Road Bangalore 560074 karnataka india |
|
|
Primary Sponsor
|
| Name |
ABHIRAMI |
| Address |
Rajarajeswari Dental College and Hospital
No 14 Ramohalli Cross Kumbalgodu Mysore Road Bangalore 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 ABHIRAMI K |
Rajarajeswari Dental College and Hospital |
Rajarajeswari Dental College and Hospital Department of Pediatric and Preventive Dentistry No14 Ramohalli Cross Kumbalgodu Mysore Road Bangalore 560074
Bangalore Rural
KARNATAKA |
8553085507
dr.abhiramik7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR ABHIRAMI K |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aquaporin 5 and Salivary Flow Rate
|
Intra-group quantification of aquaporin 5 and salivary flow rate in non-diabetic children having dental caries( group 1)before and after one month of application of topical nano sliver fluoride and fluoride mouthwash and paste. |
| Intervention |
Aquaporin 5 and Salivary Flow Rate
|
Intra-group quantification of aquaporin 5 and salivary fluoride in type 1 diabetic mellitus children having dental caries (group 2), before and after one month of application of topical nano sliver fluoride and fluoride paste and mouthwash. |
| Comparator Agent |
Aquaporin 5 and Salivary Flow Rate |
Intergroup quantification of aquaporin 5 and salivary flow rate between non-diabetic children without dental caries, (control group) non-diabetic children having dental caries(group 1)before and after one month of application of topical remineralizing agent and type 1 diabetic children having dental caries(group 2) before and after one month of topical remineralizing agent |
| Comparator Agent |
Aquaporin 5 and Salivary Flow Rate |
Intra-group quantification of aquaporin 5 and salivary flow rate in non-diabetic children without dental caries.(control group) |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with 7 to 12 years of age.
Non Diabetic children without dental caries.
Non-Diabetic Children with ICDAS II criteria CODE 03 and 04.
Children with Type1 Diabetes Mellitus having ICDAS II criteria, CODE 03 and 04.
Parents giving consent for the study
|
|
| ExclusionCriteria |
| Details |
Children who received fluoride topical application during the last 1 month.
Children requiring special health care needs.
Pulpally involved and grossly decayed teeth.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quantification of Aquaporin-5 and Salivary Flow Rate in Non-Diabetic children Without Dental Caries.
Quantification of Aquaporin-5 and Salivary Flow Rate in Non-Diabetic children having dental caries, before and after the application of topical remineralizing therapy.
|
Baseline - 1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quantification of Aquaporin-5, Salivary Flow Rate and dental caries experience in children with Type 1 Diabetes Mellitus before and after the application of topical remineralizing therapy.
Comparative Analysis of Aquaporin-5, Salivary Flow Rate, and Caries Experience between Non-diabetic and Type 1 Diabetic Mellitus children before and after the application of topical remineralizing therapy.
|
Baseline - 1 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)
|
20/07/2025 |
| 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 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
|
METHOD OF STUDY: SAMPLE COLLECTION: A total of 45 children who meets the inclusion criteria are selected for the study and grouped as follows; Control group (n=15): Non-Diabetic children with no dental caries. Experimental Group 1 (n=15): Non-Diabetic children with Dental caries greater than or equal to 3, ICDAS II criteria ,CODE 03 &04. Experimental Group 2 (n=15): Type 1 Diabetes Mellitus children with Dental caries greater than or equal to 3, ICDAS II criteria ,CODE 03 &04. All subjects will be instructed to refrain from eating and drinking for 1 hr 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 mins. Then, these tubes will be sealed immediately after sample collection and stored in laboratory at 4 degree celsius in refrigerator. DMFT/dmfs index is recorded in children from Experimental Group 1 and Experimental Group 2. Identified carious teeth will be isolated and Nano silver fluoride will be applied directly to lesions with micro brush and left for 2minutes. Post application instructions will be given and children are instructed to use fluoridated mouthwash(once daily) and fluoridated toothpaste(twice daily) at home for a period of one month. This is mainly to have regular exposure to fluoride as Aquaporin-5 is known to uptake fluoride and its levels are known to get affected by continuous fluoride exposure. The children will be recalled after one month from the day of application. Post-intervention saliva samples will be collected from Experimental Group 1 and Experimental Group 2 through same procedures as mentioned above. All the samples will be subjected to ELISA. Estimation of Flow Rate Procedure: Ensure the children refrain from eating, drinking, or brushing their teeth for at least 1 hour before the test. Children will be seated, relaxed, and avoid talking during the collection. Children will be asked to slightly bent their head forward and let saliva pool in their mouth. Unstimulated saliva will be collected in the sterile vial. Flow rate will be determined in millilitres/minute (mL/min). The results obtained will be subjected to statistical analysis. |