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CTRI Number  CTRI/2025/10/095566 [Registered on: 03/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to evaluate how using a water flosser can improve oral health and reduce gum inflammation and dental plaque in adults with plaque-related gum problems 
Scientific Title of Study   A Double-Blind, Randomized, Control-Arm Clinical Study to Evaluate the Safety and Efficacy of Test Water Flosser in Enhancing Oral Health Among Healthy Adults Having Plaque-Induced Gingivitis and Dental Plaque Accumulation. 
Trial Acronym  SHINE 
Secondary IDs if Any  
Secondary ID  Identifier 
NB250034-GN_1.0_23Sep25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jahanvi Chavda  
Designation  Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.

Ahmadabad
GUJARAT
382421
India 
Phone  09909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Sub-Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.

Ahmadabad
GUJARAT
382421
India 
Phone  09909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari N Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.

Ahmadabad
GUJARAT
382481
India 
Phone  09909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
GuruNanda LLC, 6645 Caballero Blvd, Buena Park, CA 90620, United States  
 
Primary Sponsor  
Name  GuruNanda LLC 
Address  6645 Caballero Blvd, Buena Park, CA 90620, United States  
Type of Sponsor  Other [Manufacturer of personal care products ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jahanvi Chavda  VRAJ Dental Clinic   F-F-5, Shukan Platinum, Vandematram Crossroad, New SG Rd, Gota, Ahmedabad 382481, Gujarat – India Ahmadabad GUJARAT
Ahmadabad
GUJARAT 		 7948983895

consultant@novobliss.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K050||Acute gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GuruNanda Test Water Flosser  Follow the below listed steps for product usage post brushing of teeth. 1.Fill – Add water to the tank of the Flosser 2.Insert – Add the tip to the flosser 3.Select – Choose the level of pressure 4.Floss – Guide the stream between your teeth and along the gumline 5.Clean – After use, insert the tip in the water tank and sanitize 
Comparator Agent  NIL  NA 
Intervention  No Water Flosser  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age: 18 to 65 years (both inclusive) old at the time of consent.
2) Sex: Healthy adult males and non-pregnant and non-lactating females.
3) Females of childbearing potential have a self-reported negative urine pregnancy test at the time of the screening visit and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
4) Subjects are generally in good general health as determined from recent medical history.
5) Subjects with mild to moderate gingivitis and good oral health, without hard or soft tissue lesions, with moderate gingivitis characterized by more than 30% bleeding sites and probing depths of greater than 3 mm without attachment loss.
6) Anterior teeth without restorations.
7) No dental treatments being performed before or during the study period.
8) Possessing at least 20 permanent teeth (excluding the third molars) and 5 evaluable teeth in each quadrant.
9) Subjects who agree to discontinue the use of over-the-counter any teeth products throughout the trial except for the ADA-approved toothbrush and toothpaste provided during the study.
10) Subjects who agree to refrain from the use of any other type of floss or similar dental product during the study.
11) Agree not to participate in any other oral or dental product studies during the trial.
12) Agree to return for all scheduled visits and follow study procedures.
13) Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements
 
 
ExclusionCriteria 
Details  Subjects who are undergoing treatment for gingivitis, caries, dental plaque and sensitivity.
2) Subjects are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
3) Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
4) Subjects have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
5) Subjects are present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
6) Suffering from untreated dental caries, mucosal lesions, oral tumors or severe systemic diseases that may affect periodontal diseases.
7) Subjects have any known allergies to over-the-counter oral hygiene/products.
8) Subjects have any known allergies to the trial product ingredients.
9) The subject must have participated in a clinical study with oral care or oral hygiene within 4 weeks before the screening visit of this study.
10) Any other condition which could warrant exclusion from the study, as per the Investigator’s discretion
11) Subjects who smoke and are pan eaters.
12) Subjects with hypersensitive teeth.
13) Subjects having chipped teeth and defective restorations.
14) Subjects having deep periodontal pockets.
15) Subjects having bridgework in their teeth and dentures which interrupt during evaluation.
16) Subjects undergoing treatment with antibiotics, anti-inflammatory, anticonvulsants, anti-histaminic, anti-depressant, anti-histaminic, sedatives, tranquilizers or daily analgesic drugs.
17) Subjects having uncontrolled metabolic disease.
18) Subjects’ overexposure to acidic by dietary and environment exposure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of the test product in terms of change in plaque deposition from baseline to post product usage, within product arm and between product arm.
To evaluate the effectiveness of the test product in terms of change in plaque induced gingivitis from baseline to post product usage, within product arm and between product arm
 		 Before and after usage of test product at T30 mins on Day 01, Day 15, and Day 30, by using Turesky Modification of the Quigley-Hein Index by Dentist or Dentist trained evaluator 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the effectiveness of the test product by assessing change in subjective perception questionnaire from baseline to post-product usage & between test products.  1. To assess the improvement in product perception questionnaire using quality of life questionnaire through 5-point Likert scale to evaluate the changes in plaque formation, test product compatibility from baseline prior to usage of test product & on Day 01, Day 15, & Day 30. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   14/10/2025 
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="30" 
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  

This is a double-blind, randomized, control-arm clinical study to evaluate safety and efficacy study of test water flosser in enhancing oral health among healthy adults having plaque-induced gingivitis and dental plaque accumulation in healthy adult human subjects.

A total of 64 subjects, including males and non-pregnant, non-lactating females aged between 18 and 65 years (inclusive) with mild to moderate plaque-induced gingivitis will be enrolled to ensure 60 subjects (30 subjects/arm) to complete the study.

The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining the written informed consent from the study participants. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by recruiting department prior the enrolment visit. Study participants will be told during screening (prior to enrolment) not to use any other dental products before or during the study period.

There will be a total of 3 visits during the study. The duration of the study will be 30 Days (±2 Days) from the enrolment. Subjects will be instructed to visit the facility as per below visits:

Visit 01 (Day 01): Screening, ICD obtained, Enrolment, Baseline Evaluation, Product Usage Period and T30 mins Evaluations

Visit 02 (Day 15): Test Product Usage Period, Oral Assessment

Visit 03 (Day 30): Oral Assessment, End of Study

Assessment of Efficacy parameters of product usage will be done before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days).

 
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