| CTRI Number |
CTRI/2025/12/099835 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Alcohol Based Mouthwash on Beneficial Oral Bacteria in Healthy Individuals |
|
Scientific Title of Study
|
The Effect Of Alcohol Containing Mouthwash On Salivary Nitrate Reducing Capacity In Normotensive Individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eesha |
| Designation |
MBBS Student (Batch of 2021) |
| Affiliation |
K.S. Hegde Medical Academy |
| Address |
K.S. Hegde Medical Academy, NitteDU, Deralakatte, Ullal, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8986009905 |
| Fax |
|
| Email |
eesha.21uml046@student.nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh Shenoy |
| Designation |
Professor(Periodontics) |
| Affiliation |
A.B. Shetty Memorial Institute Dental Sciences |
| Address |
A.B. Shetty Memorial Institute of Dental Sciences,4th floor, Department of Periodontics, NITTE Deemed University, Deralakatte, Ullal, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448104417 |
| Fax |
|
| Email |
drsanthoshshenoy@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santhosh Shenoy |
| Designation |
Professor(Periodontics) |
| Affiliation |
A.B. Shetty Memorial Institute Dental Sciences |
| Address |
A.B. Shetty Memorial Institute of Dental Sciences,4th floor, Department of Periodontics, NITTE Deemed University, Deralakatte, Ullal, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448104417 |
| Fax |
|
| Email |
drsanthoshshenoy@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| A.B.Shetty Memorial Institute of Dental Sciences, Department of Periodontics, 4th floor, Nitte Deemed to be University,Deralakatte, Ullal, Mangalore, 575018 |
| K.S. Hegde Medical Academy and Hospital, Nitte Deemed to be University,Deralakatte, Ullal, Mangalore, 575018 |
|
|
Primary Sponsor
|
| Name |
AB Shetty Memorial Institute of Dental Sciences NITTE University |
| Address |
A.B. Shetty Memorial Institute of Dental Sciences, Department of Periodontics,4th floor, Deralakatte, Ullal, Mangalore, 575018 |
| Type of Sponsor |
Private medical college |
|
|
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 Santhosh Shenoy |
A.B. Shetty Memorial Institute of Dental Sciences |
A.B. Shetty Memorial Institute of Dental Sciences, 4th floor, Department of Periodontics, NitteDU Campus, Deralakatte, Ullal, Mangalore 575018
Dakshina Kannada
KARNATAKA |
9448104417
drsanthoshshenoy@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee K.S. Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Senquel AD |
Alcohol-free Desensitizing Mouthwash X 14 days |
| Intervention |
Tantum Oral Rinse |
Alcohol-based Desensitizing Mouthwash X 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Healthy normotensive individuals
Prescribed de-sensitizing mouthwashes for sensitive teeth
Fasting serum glucose 70-125g/dl
BMI between 18-25
No known systemic co-morbidities
Written informed consent freely given. |
|
| ExclusionCriteria |
| Details |
Tobacco users
Periodontitis patients
Hypertensive
Diabetic/Pre-diabetic
Obesity
Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Salivary Nitrite/Nitrate Ratio |
Baseline, 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure |
Baseline, 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/02/2026 |
| 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="0"
Days="14" |
|
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
|
Research Question: Will alcohol content in a mouthwash have an effect on salivary nitrate reducing capacity? Objectives: To determine effect on salivary nitrate reducing capacity due to alcohol-based mouthwash use. To determine effect on salivary nitrate reducing capacity due to aqueous-based mouthwash use. To compare the effects of alcohol-based and aqueous based mouthwash.
Significance: Oral commensal bacteria reduce nitrates(from diet/saliva) to nitrites. Nitrites are further reduced to nitric oxide in the gut. Nitric oxide is a powerful vasodilator and contributes to blood pressure reduction. |