| CTRI Number |
CTRI/2025/12/099456 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of Alkaline Water in Counteracting Enamel pH Reduction Caused by Commercial Sport Drinks |
|
Scientific Title of Study
|
Investigating the Efficacy of Alkaline Water in Counteracting Enamel pH Reduction Caused by Commercial Sport Drinks- A Randomized Control 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 |
Satyam Upase |
| Designation |
resident |
| Affiliation |
Dr D Y Patil Dental College and Hospital Pimpri |
| Address |
Dr D Y Patil Dental College and Hospital Sant tukaram nagar Pimpri Pune
Pune
MAHARASHTRA
411021
India |
| Phone |
07744990041 |
| Fax |
|
| Email |
satyamupase11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ladusingh Rajpurohit |
| Designation |
Head of Department |
| Affiliation |
Dr D Y Patil Dental College and Hospital Pimpri |
| Address |
Dr D Y Patil Dental College and Hospital Sant tukaram nagar Pimpri Pune
Pune
MAHARASHTRA
411021
India |
| Phone |
07744990041 |
| Fax |
|
| Email |
ladusingh.rajpurohit@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Satyam Upase |
| Designation |
resident |
| Affiliation |
Dr D Y Patil Dental College and Hospital Pimpri |
| Address |
Dr D Y Patil Dental College and Hospital Sant tukaram nagar Pimpri Pune
Pune
MAHARASHTRA
411021
India |
| Phone |
07744990041 |
| Fax |
|
| Email |
satyamupase11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Satyam Upase |
| Address |
Dr D Y Patil Dental college and Hospital Pimpri Pune 411018 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Satyam Upase |
Dr D Y Patil Dental College and Hospital |
Department of Public health Dentistry, Dept no 5, Sant tukaram nagar Pimpri Pune
Pune
MAHARASHTRA |
07744990041
satyamupase11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Vidyapeeth Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alkaine water |
We are testing efficacy of alkaline water against acidity caused by sting energy drink to prevent dental erosion |
| Intervention |
Alkaline water |
We are testing efficacy of alkaline water against acidity caused by monster energy drink to prevent dental erosion |
| Intervention |
alkaline water |
We are testing efficacy of alkaline water against acidity caused by redbull energy drink to prevent dental erosion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects under age of 30
2. Subjects regularly consuming either one of 3 energy drinks taken into the study
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of any systemic disease, smoking, head trauma, upper respiratory tract infections, chemotherapy, radiation therapy, and use of any medications known to influence enamel erosion will be excluded from the study.
2. Subjects with history of smokeless form of tobacco consumption.
3. Subjects above age of 30.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Alkaline water may neutralise the acidity caused by the acidic sports energy drinks, |
immediately after the consumption of energy drinks alkaline water will be give |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/01/2026 |
| 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="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 - NO
|
|
Brief Summary
|
The consumption of sports drinks has become increasingly popular, particularly among athletes and individuals who engage in strenuous physical activity. However, these beverages are often highly acidic, with pH levels ranging from 3.10 to 3.70, which can lead to dental erosion and enamel demineralization. Alkaline water, with its higher pH level, may help neutralize acidity and prevent dental erosion. A study evaluating the effect of alkaline water on changes in pH of dental enamel after consuming different sports drinks is necessary to understand its potential benefits. This research could provide valuable insights into the preventive role of alkaline water in maintaining oral health and preventing dental erosion, ultimately informing recommendations for individuals who regularly consume sports drinks. |