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CTRI Number  CTRI/2026/02/103093 [Registered on: 05/02/2026] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of using chlorhexidine-based mouthwash on our overall health 
Scientific Title of Study   Assessing the effect of chlorhexidine-based oral hygiene regimen on nitric oxide oral bioavailability and blood pressure in children aged 12-15 years undergoing orthodontic treatment: a 12-month follow-up 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  Alok Dubey 
Designation  PhD Scholar 
Affiliation  Narsinhbhai Patel Dental College and Hospital 
Address  Narsinhbhai Patel Dental College, SK Campus, Near Kamana Chokdi, Visnagar

Mahesana
GUJARAT
384002
India 
Phone  6005181545  
Fax    
Email  dentaalok@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shoba Fernandes 
Designation  Professor and Head 
Affiliation  Narsinhbhai Patel Dental College And Hospital 
Address  Narsinhbhai Patel Dental College And Hospital. VISNAGAR.

Mahesana
GUJARAT
384315
India 
Phone  6005181545  
Fax    
Email  vshobaf@gmail.com  
 
Details of Contact Person
Public Query  
Name  Alok Dubey 
Designation  PhD Scholar 
Affiliation  Narsinhbhai Patel Dental College and Hospital 
Address  Narsinhbhai Patel Dental College, SK Campus, Near Kamana Chokdi, Visnagar

Mahesana
GUJARAT
384002
India 
Phone  6005181545  
Fax    
Email  dentaalok@yahoo.com  
 
Source of Monetary or Material Support  
Narsinhbhai Patel Dental College, SK Campus, Near Kamana Chokdi, Visnagar Mehsana, Gujarat PIN: 384002 India 
 
Primary Sponsor  
Name  Alok Dubey 
Address  Department of Pediatric and Preventive dentistry NPDCH Visnagar 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ALOK DUBEY  NARSINHBHAI PATEL DENTAL COLLEGE & HOSPITAL  Department of Pediatric and Preventive Dentistry
Mahesana
GUJARAT 		 6005181545

dentaalok@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Narsingh bhai Patel Dental College and Hospital, Visnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K121||Other forms of stomatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chlorhexidine mouth wash  Dose: 15ml, 0.12% chlorhexidine gluconate mouthwash (Peridex) Frequency: twice daily Route: Topical Transmucosal Duration: Phase I (4 weeks), Phase II (4 weeks) 
Comparator Agent  Placebo mouthwash without chlorhexidine  Dose: 15 ml, 0.092% Eucalyptol based mouthwash (Listerine) Frequency: twice daily Route: Topical Transmucosal Duration: Phase I (4 weeks), Phase II (4 weeks) 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Adolescents planned for fixed orthodontic treatment with an expected more than 12 months duration.
Healthy individuals free from systemic diseases.
Non-smokers.
No history of hypertension or cardiovascular disorders.
Willingness to participate in the study and comply with the protocol.
 
 
ExclusionCriteria 
Details  Presence of systemic illness or cardiovascular disorders.
Psychological or physical disabilities interfering with participation.
Obese children. (Sex specific BMI range is 95th percentile or greater)
Plans to relocate within 12-14 months, leading to potential loss of follow-up.
Known allergies or adverse reactions to chlorhexidine mouthwash.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study aims to provide clinically significant data regarding the systemic impact of long-term chlorhexidine mouthwash use on nitric oxide bioavailability and blood pressure in adolescents.  Phase I:
Baseline reading, Record clinical readings at weekly intervals over 4 weeks.

Phase II: After a 3-month washout period, resume CHX use and again record weekly
readings for another 4 weeks at weekly intervals.
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   25/02/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Overview:

This study will evaluate the long-term effects of a chlorhexidine-based oral hygiene regimen on salivary NO levels and blood pressure in orthodontic patients over 12 months in children aged 12-15 years. By assessing changes in nitric oxide bioavailability and blood pressure at regular intervals, this study will provide insights into potential systemic implications of prolonged antibacterial mouthwash use in this population.

Aim:

To evaluate the long-term effects of a chlorhexidine-based oral hygiene regimen on nitric oxide bioavailability and blood pressure in adolescents undergoing orthodontic treatment.

 Objectives:

1.     To assess the impact of prolonged chlorhexidine mouthwash use on salivary nitric oxide levels over 12 months.

2.     To monitor changes in systolic and diastolic blood pressure in adolescents using chlorhexidine mouthwash as part of their oral hygiene routine.

3.     To compare nitric oxide bioavailability between orthodontic patients using chlorhexidine mouthwash and those using placebo mouthwash.

4.     To evaluate potential correlations between reduced salivary nitric oxide levels and variations in blood pressure.

5.     To analyse whether alterations in oral microbial composition due to chlorhexidine use contribute to changes in nitric oxide metabolism and systemic vascular responses.

6.     To provide clinical recommendations regarding the long-term safety of chlorhexidine-based mouthwashes in orthodontic patients.

 Methodology:

A.    Materials/Equipment for the Study

1. Oral Hygiene Products:

0.12% Chlorhexidine gluconate mouthwash (Peridex) for the test group.

Placebo mouthwash for the control group.

2. Blood Pressure Measurement Equipment:

Mercury sphygmomanometer (Korotkoff auscultatory method) to measure systolic and diastolic blood pressure.

Standardized BP cuff and stethoscope for repeated measures.

3. BMI measurement Equipment:

Metal Tape measure to record height to the nearest 1/8th inch or 0.1 centimeter.

Digital body weighing scale to record weight to the nearest decimal fraction.

4. Salivary Nitric Oxide Assessment:

Saliva nitric oxide test strips to monitor NO levels as per manufacturer instructions.

 B.    Sample description

Participants will be categorized into two groups:

  1. Test Group: Adolescents using 0.12% chlorhexidine gluconate mouthwash (Peridex) twice daily as part of their oral hygiene routine.
  2. Control Group: Adolescents using Placebo mouthwash without chlorhexidine.

Both groups will be assessed for changes in salivary nitric oxide levels and blood pressure over the study period.

C.    Time Scale of Study

The study will be conducted over a total period of 12 months.

Phase I: Record clinical readings at weekly intervals over 4 weeks.

Phase II: After a 3-month washout period, resume CHX use and again record weekly

readings for another 4 weeks.

A 3-month washout period would allow us to assess both the short-term and any potential long-term effects without continuous exposure.

At each time point, blood pressure and salivary nitric oxide levels will be measured to track changes over time. 

 
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