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CTRI Number  CTRI/2026/03/106134 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 18/09/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive
Dentistry
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare and evaluate water flosser and interdental brush use for reducing gum disease. 
Scientific Title of Study   Effect of water flosser use compared with interdental brush on salivary IL-4 and IL-6 on plaque-induced gingivitis. 
Trial Acronym  IL-4, IL-6 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikita Nagaraj Hoskeri 
Designation  MDS 
Affiliation  A B Shetty Memorial institute of Dental Sciences 
Address  AB Shetty Memorial Institute of Dental Sciences ,Deralakatte , Mangaluru, Karnataka 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9757486386  
Fax    
Email  nikita.25dper04@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Rahul Bhandary 
Designation  Professor 
Affiliation  A B Shetty Memorial institute of Dental Sciences 
Address  AB Shetty Memorial Institute of Dental Sciences ,Deralakatte , Mangaluru, Karnataka 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845583085  
Fax    
Email  drrahulbhandary@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Nikita Nagaraj Hoskeri 
Designation  MDS 
Affiliation  A B Shetty Memorial institute of Dental Sciences 
Address  AB Shetty Memorial Institute of Dental Sciences ,Deralakatte , Mangaluru, Karnataka 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9757486386  
Fax    
Email  nikita.25dper04@student.nitte.edu.in  
 
Source of Monetary or Material Support  
AB Shetty Memorial Institute of Dental Sciences ,Deralakatte , Mangaluru, Karnataka 575018  
 
Primary Sponsor  
Name  AB Shetty Memorial Institute of Dental Sciences 
Address  AB Shetty Memorial Institute of Dental Sciences NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka – 575018 India 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Nikita Nagaraj Hoskeri  AB Shetty Memorial Institute of Dental Sciences  Department of Periodontology, 4th floor, Room number 8,AB Shetty Memorial Institute of Dental Sciences ,Deralakatte , Mangaluru,Dakshina Kannada KARNATAKA-575018
Dakshina Kannada
KARNATAKA 		 9757486386

nikita.25dper04@student.nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ABSMIDS Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Interdental Brush   Patients will be advised to perform their interdental cleaning procedure with an interdental brush for a period of 4 weeks along with instructions to maintain twice-daily toothbrushing. 
Intervention  Water Flosser  Patients will be advised to perform their interdental cleaning procedure with a water-flosser for a period of 4 weeks along with instructions to maintain twice-daily toothbrushing. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Adults between 18-40 years of age with plaque induced gingivitis.
2. Patients with periodontal pocket depth less than 3mm and no clinical attachment loss.
3. Patients willing for participation and have provided written consent
 
 
ExclusionCriteria 
Details  1. Patients suffering from systemic diseases, which may have an impact on the periodontium, such as diabetes mellitus and osteoporosis.
2. Unco-operative patients
3. Patients on antibiotics and/or anti-inflammatory drugs.
4. Patients with periodontal disease, as characterized by purulent exudates, generalized mobility, and/or severe recession
5. Pregnant and lactating mothers
6. Smokers and smokeless tobacco users.
7. Patient with orthodontic appliance or prosthetic appliance.
 
 
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 and compare change in salivary IL-4 and IL-6 levels measured using ELISA in different interdental aids   Assessment done at baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare changes in clinical parameters with different interdental aids  Assessment done at baseline and 4 weeks  
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/04/2026 
Date of Study Completion (India) 24/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 24/06/2026 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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
Modification(s)  		 This study titled "Effect of water flosser use compared with interdental brush on salivary IL-4 and IL-6 on plaque-induced gingivitis" aims to evaluate and compare effect of water flosser use in management of dental plaque and gingival inflammation as compared to interdental brush. Water flossers are oral irrigation devices that deliver pulsating streams of water to disrupt and flush out dental plaque and debris from interproximal and subgingival areas. In this study participants will be instructed to use a cordless water flosser (ORACURA Smart Water Flosser, Model OC150) once daily for interdental cleaning for a period of 4 weeks. The device will be standardized at a moderate pulsating pressure of approximately 60 PSI with a pulsation frequency of 1200–1800 pulses per minute. Several clinical studies have reported improvements in gingival inflammation and plaque control with the use of water flossers. However, most of the available evidence is based primarily on clinical indices, and there is limited research evaluating the biological or inflammatory response associated with their use. Salivary biomarkers provide a non-invasive method to assess inflammatory changes in periodontal tissues. Interleukin-6 (IL-6) is a pro-inflammatory cytokine involved in the progression of gingival inflammation, while Interleukin-4 (IL-4) is an anti-inflammatory cytokine associated with immune modulation. Changes in the salivary levels of these biomarkers can reflect the inflammatory status of gingival tissues and the response to oral hygiene interventions.

This single-blind randomized controlled clinical trial will be conducted among patients with plaque-induced gingivitis attending the outpatient department of Periodontology at AB Shetty Memorial Institute of Dental Sciences. A total of 52 participants will be randomly allocated into two groups: water flosser group and interdental brush group. Clinical parameters including Plaque Index, Gingival Index, and Bleeding on Probing will be assessed at baseline and 4 weeks. Salivary samples will be collected and analysed for IL-4 and IL-6 levels using ELISA. The study aims to evaluate and compare the clinical and inflammatory effects of water flosser and interdental brush in the management of plaque-induced gingivitis.


 

 
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