| CTRI Number |
CTRI/2026/02/104686 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [sugar substitutes] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Diffrent Sugar Substitutes Combined with Milk in Reducing Cavity Causing Bacterial Levels in Children |
|
Scientific Title of Study
|
Evaluation And Comparison Of Salivary Aquaporin-5 Level and Streptococcus Mutans Counts In Children Before And After Consumption Of Milk Sweetend With Xylitol,D-Allulose And Monk Fruit Sugar Substitutes-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 Prathibha Gunasekaran |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital Room No.6 Departemnt of Pediatric and Preventive Dentistry No.14 Ramohalli Cross Kumbalgodu Bengaluru Karnataka 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9380617811 |
| Fax |
|
| Email |
prathigunasekaran475@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya AR |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Dental College And Hospital |
| Address |
Rajarajeswari Dental College and Hospital Room No.6 Department of Pediatric and Preventive Dentistry No.14 Ramohalli Cross Kumbalgodu Bengaluru Karnataka 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9880038038 |
| Fax |
|
| Email |
jaya.vrushabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr prathibha Gunasekaran |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital Room No.6 Departemnt of Pediatric and Preventive Dentistry No.14 Ramohalli Cross Kumbalgodu Bengaluru Karnataka 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9380617811 |
| Fax |
|
| Email |
prathigunasekaran475@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College and Hospital No 14 Ramohalli cross Mysore road Kumbalgodu Bengaluru 560074 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Prathibha Gunasekaran |
| Address |
Rajarajeswari Dental College and Hospital Room No.6 Department of Pediatric and Preventive Dentistry No.14 Ramohalli Cross Kumbalgodu 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 Prathibha Gunasekaran |
Rajarajeswari Dental College and Hospital |
Room No.6 Departemnt of Pediatric and Preventive Dentistry No.14 Ramohalli Cross Kumbalgodu Bengaluru Karnataka 560074
Bangalore Rural
KARNATAKA |
9380617811
prathigunasekaran475@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari Dental College Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with three or more Dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
D Allulose sugar substitute |
salivary Aquaporin 5 level and Streptococcus Mutans counts in children at baseline and 1 month after consumption of milk sweetened with commercially available D Allulose sugar substitute will be done. |
| Comparator Agent |
Inter group comparison among the three different sugar substitutes. |
To compare the changes amongst salivary Aquaporin 5 Level and Streptococcus Mutans counts in children at baseline and 1 month after consumption of milk sweetened with Xylitol, D Allulose and Monk Fruit groups will be done. |
| Intervention |
Monk fruit sugar substitute |
salivary Aquaporin 5 level and Streptococcus Mutans counts in children at baseline and 1 month after consumption of milk sweetened with commercially available Monk fruit sugar substitute will be done |
| Intervention |
xylitol sugar substitute |
salivary Aquaporin 5 level and Streptococcus Mutans counts in children at baseline and 1 month after consumption of milk sweetened with commercially available Xylitol sugar substitute will be done. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Children aged 5-9 years of age.
2. Children with DMFT or dmft DC greater than or equal to 3, ICDAS 2 criteria with CODE 03 and 04.
3.Children who have not previously received sugar substitute therapy.
4.Children without any systemic disease.
5. Children who consumes milk at least three times per week.
6.No history of intolerance or adverse reaction to milk or sugar substitutes.
7.Written informed consent obtained from parents or guardians. |
|
| ExclusionCriteria |
| Details |
1.Children with metabolic disorders, gastrointestinal Diseases and severe chronic illnesses.
2.Children with milk protein allergy, lactose intolerance or known hypersensitivity to sugar substitutes.
3.Children with Recent history of antibiotic usage.
4. Parents or children are unwilling to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Salivary Aquaporin 5 Levels and Streptococcus Mutans Counts In Children Before and After Consumption of Milk Sweetened with Xylitol, D Allulose and Monk Fruit Sugar Substitutes using Elisa and Mitis Salivarius Bacitracin Agar. |
Base line
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of Salivary Aquaporin 5 Levels and Streptococcus Mutans Counts In Children Before and After Consumption of Milk Sweetened with Xylitol,D Allulose,Monk Fruit Sugar Substitutes |
Base line
one 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 3 |
|
Date of First Enrollment (India)
|
10/08/2026 |
| 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
|
A total of 45 eligible children will be randomly allocated into three groups with15 each Group 1 Healthy Children receiving milk sweetened with xylitol sugar substitute. Group 2 Healthy Children receiving milk sweetened with D Allulose sugar substitute. Group 3 Healthy Children receiving milk sweetened with Monk Fruit sugar substitute. All participants will be instructed to refrain from eating or drinking for one hour prior to saliva collection. Children are instructed to rinse with filtered water and Pre intervention unstimulated saliva samples will be collected using spitting method. Samples will be collected over a period of five minutes, sealed immediately and stored at minus 20 degree celsius. Intervention protocol Group 1. 4g per day xylitol, 2g with 100ml milk in the morning and evening. Group 2. 4g per day D Allulose, 2g with 100ml milk in the morning and evening. Group 3. 1g per day Monk Fruit sugar substitute ,0.5g with 100ml of milk in the morning and evening to be followed for 1 month. Bilingual instruction sheets will be provided to parents and daily reminder notification will be sent through a mobile application app every morning and evening to ensure compliances. Post intervention saliva samples will be collected after one month following the same protocol. All samples will be analysed for Aquaporin 5 using ELISA and for Streptococcus mutans using Mitis salivarius bacitracin agar. The results obtained will be subjected to statistical analysis. |