| CTRI Number |
CTRI/2025/01/079779 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
"Understanding How Sweeteners in Milk Affect the Oral Health of Children" |
|
Scientific Title of Study
|
Evaluation of Salivary and Plaque Acidogenicity of Various Sweeteners in Milk Among Children: 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 |
SWETHA T |
| Designation |
Undergraguate student |
| Affiliation |
Tagore Dental College And Hospital |
| Address |
Department of Pediatrics and Preventive Dentistry
Salem
TAMIL NADU
636302
India |
| Phone |
6381154385 |
| Fax |
|
| Email |
swethavarun2k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AHSANA |
| Designation |
Senior Lecturer |
| Affiliation |
Tagore Dental College And Hospital |
| Address |
Department of Pediatrics and Preventive Dentistry
Chennai
TAMIL NADU
600127
India |
| Phone |
9176543653 |
| Fax |
|
| Email |
drahsanaasif@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AHSANA |
| Designation |
Senior Lecturer |
| Affiliation |
Tagore Dental College And Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
TAMIL NADU
600127
India |
| Phone |
9176543653 |
| Fax |
|
| Email |
drahsanaasif@gmail.com |
|
|
Source of Monetary or Material Support
|
| TAGORE DENTAL COLLEGE AND HOSPITAL,Near Vandalur,Melakkottaiyur Post,Rathinamangalam,Tamil Nadu 600127,India |
|
|
Primary Sponsor
|
| Name |
Tagore Dental College and Hospital |
| Address |
TAGORE DENTAL COLLEGE AND HOSPITAL,Near Vandalur,Melakkottaiyur Post,Rathinamangalam,Tamil Nadu 600127,India |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Swetha |
Tagore Dental College And Hospital |
Department of Pediatrics and Preventive Dentistry, Tagore Dental College And Hospital,Near Vandalur,Melakkottaiyur Post,Rathinamangalam,Tamil Nadu 600127,India
Chennai
TAMIL NADU |
06381154385
swethavarun2k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TAGORE DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NOT APPLICABLE
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control |
25ml of 10% sucrose solution
Swish and spit : 1 minute
Total Study Duration: 30 minutes |
| Intervention |
Milk With Dates Syrup |
25 ml of milk with ½ tablespoon of dates syrup
Swish and spit : 1 minute
Total Study Duration: 30 minutes |
| Intervention |
Milk With Palm Sugar |
25 ml of milk with ½ tablespoon of palm sugar
Swish and spit : 1 minute
Total Study Duration: 30 minutes |
| Intervention |
Milk With White Sugar |
25 ml of milk with ½ tablespoon of white sugar
Swish and spit : 1 minute
Total Study Duration: 30 minutes |
| Comparator Agent |
Plain milk |
25 ml of plain milk with no sweetener added
Swish and spit : 1 minute
Total Study Duration: 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Age: Children aged between 6 to 8 years.
Dental Status: Children with a DMFT (Decayed, Missing, and Filled Teeth) score less than 2.
Health Status: Healthy children without any systemic diseases.
Oral Hygiene: Children with a Good Oral Hygiene Index.
Behavioral Assessment: Children scoring 3 (positive) or 4 (definitely positive) on Frankl’s Behavior Rating Scale. |
|
| ExclusionCriteria |
| Details |
1.Children who are not in the habit of consuming milk.
2.Children who have an intolerance to milk protein.
3.Children who have a history of recent hospitalization, take medications that affect the salivary flow rate.
4.Medically compromised children.
5.Children having unerupted / partially erupted 1st permanent molars
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in salivary acidogenicity and plaque acidogenicity (measured by pH levels) after exposure to the milk with various sweeteners.
2.The interventionional impact on the pH levels of saliva and plaque will be measured to assess the acidogenic potential of the sweeteners. |
Changes in salivary acidogenicity and plaque acidogenicity (measured by pH levels) after exposure to the milk with various sweeteners
at baseline,5 minutes,10 minutes,20minutes and 30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2025 |
| 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)
|
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 - 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
- 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 - Proposals should be directed to [swethavarun2k@gmail.com].
- For how long will this data be available start date provided 09-01-2025 and end date provided 30-12-2033?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This pilot study aims to evaluate the effect of different sweeteners (white sugar, palm sugar, dates syrup) on salivary and plaque acidogenicity in children aged 6-8 years. The participants will be randomly assigned to one of five groups: control (10% sucrose), plain milk, milk with white sugar, milk with palm sugar, or milk with dates syrup. The primary outcome is the change in salivary and plaque pH levels within 30 minutes post-intervention. The study will also compare acidogenicity across the sweeteners. |