| CTRI Number |
CTRI/2024/09/074248 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Preventive
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Assessment of calorie free sweeteners and probiotics on oral health in children |
|
Scientific Title of Study
|
Comparative analysis of the effect of calorie free sweeteners and probiotics on the oral microbial concentration in children: a randomised 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 |
Aardra B S |
| Designation |
UG research graduate |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric Dentistry, Saveetha Dental College and Hospital, 162, Poonamallee High Road, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9526066100 |
| Fax |
|
| Email |
152101004.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh R |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric Dentistry, Saveetha Dental College and Hospital, 162, Poonamallee High Road, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh R |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric Dentistry, Saveetha Dental College and Hospital, 162, Poonamallee High Road, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric Dentistry, 5th Floor, Saveetha Dental College and Hospital, SIMATS University, 162, Poonamallee High Road, Velappanchavadi, Chennai, TN, India — 600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric Dentistry, 5th Floor, Saveetha Dental College and Hospital, SIMATS University, 162, Poonamallee High Road, Velappanchavadi, Chennai, TN, India — 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ramesh R |
Saveetha Dental College and Hospital |
Department of Pediatric Dentistry, Clinic 28, 5th Floor, SIMATS University, 162, Poonamallee High Road, Velappanchavadi
Chennai
TAMIL NADU |
9895725236
rameshr.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
HealthyHey Nutrition Probiotics 50 Billion CFU Multi-Strain Veg Capsules |
| Intervention |
Intervention Group |
Xylitol (So Sweet Xylitol Natural Sweetener, Sugar-Free), Aspartame (Sweet and Healthy Low-Calorie Aspartame-Based Sweetener), or Stevia (Magic Leaf Stevia Extract Sugar-Free Sweetener Powder) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with no systemic diseases
Children not currently taking antibiotics or other medications affecting oral health
Children whose parents are willing for informed consent
|
|
| ExclusionCriteria |
| Details |
Children with known allergies to probiotics or sweeteners
Children with significant dental treatments within the past three months
Children who do not consume more than 65% of the time frame (will be eliminated from the study group) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral microbial concentration assessed through saliva samples |
Baseline - 1 hour after consumption, 1 week, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival index
Oral hygiene index (OHI)
ICDAS |
Baseline, 1 week, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
04/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Results will be published and data will be made accessible
- For how long will this data be available start date provided 18-09-2024 and end date provided 18-09-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This randomized controlled trial compares the effects of calorie-free sweeteners (aspartame, stevia, xylitol) and probiotics on oral microbial concentration in children aged 6-12. A total of 120 participants are randomly assigned into four groups of 30. Group 1 receives aspartame, Group 2 receives stevia, Group 3 receives xylitol, and Group 4 receives probiotics. The intervention lasts for 4 weeks, with follow-up assessments at baseline, 1 week, and 4 weeks. Saliva samples are collected at baseline, 1 hour after consumption, and at subsequent time points to measure oral microbial concentration using quantitative PCR (qPCR) and microbial culture techniques.
Secondary outcomes include changes in gingival health and caries status, evaluated through the gingival index, Oral Hygiene Index (OHI), and International Caries Detection and Assessment System (ICDAS) index. Children with systemic diseases, recent dental treatments, or allergies to probiotics/sweeteners are excluded. Compliance is monitored by parents using a "sweet diary."
The study provides insight into the potential effects of calorie-free sweeteners and probiotics on children’s oral microbial health and dental outcomes, including caries risk and gingival health. |