| CTRI Number |
CTRI/2024/07/070032 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare and evaluate oral hygiene and hydration status of athletes of age group of 10-14 years |
|
Scientific Title of Study
|
Comparative evaluation of Oral hygiene and hydration status of athletes aged 10 – 14 years consuming Kangen water, energy sports drink & normal water. A Randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Utkarsha Kadam |
| Designation |
Pg Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept. of Pediatric and Preventive Dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur Maharashtra 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8329603682 |
| Fax |
|
| Email |
utkarshakadam11@gnail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Utkarsha Kadam |
| Designation |
Pg Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept. of pediatric and Preventive Dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur Maharashtra 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8329603682 |
| Fax |
|
| Email |
utkarshakadam11@gnail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritesh Kalaskar |
| Designation |
Professor and HOD |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept. of pediatric and Preventive Dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur MAHARASHTRA 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8550938585 |
| Fax |
|
| Email |
riteshpedo1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College And Hospital Nagpur |
|
|
Primary Sponsor
|
| Name |
Utkarsha Kadam |
| Address |
Dept. of pediatric and Preventive Dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur MAHARASHTRA 440003 India |
| Type of Sponsor |
Other [Government Dental College And Hospital Nagpur] |
|
|
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 Utkarsha Kadam |
Government Dental College and Hospital Nagpur |
Sport Acadamy of Nagpur Region
Nagpur
MAHARASHTRA |
8329603682
utkarshakadam11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College And Hospital Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral hygeine and hydration status of athlets of aged 10-14 years old |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Energy sport drink |
Athlets who is consuming energy sport drink during sport activity. |
| Intervention |
Kangen water |
Atheltes who is consuming kanegn water during sport activity |
| Comparator Agent |
Normal water |
Athletes who is consuming normal water during sport activity |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Athlete of age group 10-14 years.
Athlete with body mass index (BMI) between
18.5-24.9
Athletes who are willing to participate in
the study.
|
|
| ExclusionCriteria |
| Details |
Athlete having any systemic disease.
History of oral prophylaxis at least 3
months before study.
History of antibiotic therapy at least 3
months before study.
Parents or caretakers not willing to
participate in this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare plaque level, salivary pH, and Streptococcus Mutans in athletes consuming Kangen water, energy sports drinks, and normal water. at baseline, 14 days and 28 days interval. |
To evaluate & compare plaque level, salivary pH, and Streptococcus Mutans in athletes consuming Kangen water, energy sports drinks, and normal water. at baseline, 14 days and 28 days interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare the hydration status (body weight, heart rate, blood pressure, breathing rate, body temperature) of athletes consuming Kangen water, energy sports drinks & normal water.
To evaluate the acceptance of Kangen water, energy sports drinks, & normal water as an energy enhancer by athletes 10 – 14 years old.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
Final Enrollment numbers achieved (Total)= "81"
Final Enrollment numbers achieved (India)="81" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/08/2024 |
| Date of Study Completion (India) |
12/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is prospective, three-arm, single-blinded
Randomized controlled trial evaluating the oral hygeine of athlets of aged 10-14 years old consuming kangen water, energy sport drink and normal water as a primary objective & evaluate & compare the hydration status (body
weight, heart rate, blood pressure, breathing rate, body temperature) of
athletes consuming Kangen water, energy sports drinks & normal water as additional objectives and evaluate the acceptance of Kangen water, energy sports drinks, and normal water
as an energy enhancer by athletes 10 – 14 years old. |