| CTRI Number |
CTRI/2025/10/096157 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to check if natural sweeteners(Date palm jaggery, coconut sugar, Maple syrup) affect acidity of saliva |
|
Scientific Title of Study
|
Effect of Consuming Tea Prepared with Natural Sweeteners on salivary pH in young adults: A crossover randomized 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 |
Dr Ekta Thakur |
| Designation |
Junior Resident II |
| Affiliation |
Department of Public Health dentistry Goa Dental College and Hospital |
| Address |
Room NO 8 Department of Public Health Dentistry, Goa Dental College and Hospital, Bambolim North Goa
North Goa
GOA
403202
India |
| Phone |
7756822733 |
| Fax |
|
| Email |
ektathakur414@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ridhima Gaunkar |
| Designation |
Professor |
| Affiliation |
Department of Public Health Dentistry Goa Dental College and Hospital |
| Address |
Room NO 8 Department of Public Health Dentistry, Goa Dental College and Hospital, Bambolim North Goa
North Goa
GOA
403402
India |
| Phone |
9326469134 |
| Fax |
|
| Email |
drbirmani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshatha Gadiyar |
| Designation |
Assistant Professor |
| Affiliation |
Department of Public Health Dentistry Goa Dental College and Hospital |
| Address |
Room NO 8 Department of Public Health Dentistry, Goa Dental College and Hospital, Bambolim North Goa
North Goa
GOA
403202
India |
| Phone |
9740541867 |
| Fax |
|
| Email |
aksgadiyar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ekta Thakur |
| Address |
Department of Public Health Dentistry, Room no.8,Goa Dental College and Hospital, Bambolim, North Goa 403202 |
| Type of Sponsor |
Other [Self Sponsored by Dr.Ekta Thakur] |
|
|
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 Ekta Thakur |
Goa Dental College and Hospital |
Room no 8, Department of Public Health Dentistry.
North Goa
GOA |
7756822733
thakurekta594@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
prevention of dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tea sweetened with coconut sugar. |
After baseline saliva sample collection participants will consume 80-ml portions of tea sweetened with coconut sugar. |
| Comparator Agent |
1.Tea with sucrose(table sugar)
|
1.After baseline saliva sample collection participants will consume 80-ml portions of tea sweetened with sucrose
|
| Intervention |
Tea sweetened with Date palm jaggery. |
After baseline saliva sample collection participants will consume 80-ml portions of tea sweetened with date palm jaggery. |
| Intervention |
Tea sweetened with Maple syryp |
After baseline saliva sample collection participants will consume 80-ml portions of tea sweetened with Maple syrup.
|
| Comparator Agent |
unsweetened Tea. |
After baseline saliva sample collection participants will consume 80-ml portions of unsweetened tea. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals aged 20 – 30 years.
No active dental caries or dental treatments within the last six months.
Willingness to participate and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Those on any medication that would alter the salivary flow.
Using any mouthwash for maintaining oral hygiene.
Having any painful, debilitating oral condition.
History of allergies to any sweeteners. |
|
|
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 |
| change in salivary pH after consumption of tea sweetened with Date palm Jaggery, Coconut sugar, Maple syrup and sucrose |
pH measurement at baseline, 1 minute, 20 and 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
31/10/2025 |
| 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="0"
Months="2"
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
|
Sucrose, a widely used sweetener, lowers salivary pH and promotes dental caries, earning it the label “arch criminal” in oral health. Rising awareness of sugar-related health risks has increased interest in natural alternatives like maple syrup, coconut sugar, and date palm jaggery. Their effect on salivary pH remains underexplored. Tea, commonly sweetened with sucrose, offers a practical medium to assess these natural sweetener’s impact on salivary pH. Objectives To evaluate the effect of tea prepared with natural sweeteners on salivary pH in adults, compared to tea sweetened with sucrose. To assess their acceptability in tea.
Methodology The study will be conducted among interns posted in the Department of Public Health Dentistry, Goa Dental College and Hospital. A Latin square cross over design will be employed with a total sample of 25 participants. Salivary pH assessment will be done at baseline, and 1, 20 and 60 minutes post tea consumption. Data will be analysed using Repeated measures ANOVA followed by Tukey’s post-hoc tests for multiple comparisons. |