Plaque Induced GingivitisNCT07204951
Clinical Safety and Efficacy Study of Water Flosser in Enhancing Oral Health Among Healthy Adults Having Plaque-induced Gingivitis and Dental Plaque Accumulation
A study testing Gurunanda - Water Flosser and No water Flossing in people with Plaque Induced Gingivitis, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
This is a double-blind, randomized, control-arm clinical study to evaluate safety and efficacy of test water flosser in enhancing oral health among healthy adults having plaque-induced gingivitis and dental plaque accumulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingivitis
- What is being tested?
- Gurunanda - Water Flosser and No water Flossing
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndia
- Study dates
- 13 Nov 2025to 14 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 to 65 years (both inclusive) old at the time of consent.
- Sex: Healthy adult males and non-pregnant/non-lactating females.
- 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.
- Subjects are generally in good general health as determined from recent medical history.
- 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 ≤3 mm without attachment loss.
- Anterior teeth without restorations.
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- No dental treatments being performed before or during the study period.
- Possessing at least 20 permanent teeth (excluding the third molars) and 5 evaluable teeth in each quadrant.
- 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.
- Subjects who agree to refrain from the use of any other type of floss or similar dental product during the study.
- Agree not to participate in any other oral/dental product studies during the trial.
- Agree to return for all scheduled visits and follow study procedures.
- Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
Who cannot join
- Subjects who are undergoing treatment for gingivitis, caries, dental plaque and sensitivity.
- Subjects are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
- Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
- 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.
- 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.
- Suffering from untreated dental caries, mucosal lesions, oral tumors or severe systemic diseases that may affect periodontal diseases.
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- Subjects have any known allergies to over-the-counter oral hygiene/products.
- Subjects have any known allergies to the trial product ingredients.
- 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.
- Any other condition which could warrant exclusion from the study, as per the Investigator's discretion
- Subjects who smoke and are pan eaters.
- Subjects with hypersensitive teeth.
- Subjects having chipped teeth and defective restorations.
- Subjects having deep periodontal pockets.
- Subjects having bridgework in their teeth and dentures which interrupt during evaluation.
- Subjects undergoing treatment with antibiotics, anti-inflammatory, anticonvulsants, anti-histaminic, anti-depressant, anti-histaminic, sedatives, tranquilizers or daily analgesic drugs.
- Subjects having uncontrolled metabolic disease.
- Subjects' overexposure to acidic by dietary and environment exposure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This is a double-blind, randomized, control-arm clinical study to evaluate safety and efficacy of test water flosser in enhancing oral health among healthy adults having plaque-induced gingivitis and dental plaque accumulation.
Read the detailed description
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. Subjects will be screened as per the inclusion \& exclusion criteria after obtaining written informed consent.
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.
Visit 01(Day 01): Screening, ICD obtained, Enrolment, Baseline Evaluation, Product Usage \& T30mins Evaluations.
Visit 02 [Day 15 ((±2 Days)]: Test Product Usage Period, Oral Assessments Visit 03[Day 30 (±2 Days)]: Oral Assessments, End of Study.
- Conditions
- Plaque Induced Gingivitis
- Being tested
- Gurunanda - Water Flosser, No water Flossing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gurunanda - Water FlosserDevice
Mode of Usage: Follow the below listed steps for product usage post brushing of teeth.
- Fill - Add water to the tank of the Flosser
- Insert - Add the tip to the flosser
- Select - Choose the level of pressure
- Floss - Guide the stream between your teeth and along the gumline
- Clean - After use, insert the tip in the water tank and sanitize Frequency: Use twice a day after brushing. Route of administration: Topical - Oral Storage Condition: Store in a cool, dry place, away from direct sunlight, and do not submerge in water.
No water FlossingOther
No water Flossing
| Study group | Role | What they receive |
|---|---|---|
| Gurunanda - Water Flosser | Experimental | Mode of Usage: 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 Frequency: Use twice a day after brushing. Route of administration: Topical - Oral Storage Condition: Store in a cool, dry place, away from direct sunlight, and do not submerge in water. Receives: Device: Gurunanda - Water Flosser |
| No water Flossing | Experimental | Not described Receives: Other: No water Flossing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of the test product in terms of change in plaque deposition
By using Turesky Modification of the Quigley-Hein Index by Dentist or Dentist trained evaluator.
Measured: Before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days)
To assess the effectiveness of the test product in terms of change in plaque induced gingivitis
By using Loe \& Silness Gingival Index by Dentist or Dentist trained evaluator.
Measured: Before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days)
Secondary outcomes (1)
To assess the improvement in product perception questionnaire
Quality of life questionnaire through 5-point Likert scale to evaluate the changes in plaque formation
Measured: Baseline prior to usage of test product and on Day 01, Day 15 (±2 days), and Day 30 (±2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start13 Nov 2025
- Primary completion14 Feb 2026
- Study completion14 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- GuruNanda LLC
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, Study director, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204951
- Sponsor's protocol ID
- NB250034-GN_1.0_23Sep25
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07204951
- Acronym / sponsor ID
- NB250034-GN_1.0_23Sep25
- Conditions
- Plaque Induced Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- GuruNanda LLC
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 14 Feb 2026 (actual)
- Study completion
- 14 Feb 2026 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomized, control-arm clinical study to evaluate safety and efficacy of test water flosser in enhancing oral health among healthy adults having plaque-induced gingivitis and dental plaque accumulation.
Detailed description
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. Subjects will be screened as per the inclusion \& exclusion criteria after obtaining written informed consent.
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.
Visit 01(Day 01): Screening, ICD obtained, Enrolment, Baseline Evaluation, Product Usage \& T30mins Evaluations.
Visit 02 [Day 15 ((±2 Days)]: Test Product Usage Period, Oral Assessments Visit 03[Day 30 (±2 Days)]: Oral Assessments, End of Study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gurunanda - Water Flosser | Experimental | Device: Gurunanda - Water FlosserMode of Usage: 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 Frequency: Use twice a day after brushing. Route of administration: Topical - Oral Storage Condition: Store in a cool, dry place, away from direct sunlight, and do not submerge in water. |
| No water Flossing | Experimental | Other: No water Flossing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18 to 65 years (both inclusive) old at the time of consent.
- Sex: Healthy adult males and non-pregnant/non-lactating females.
- 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.
- Subjects are generally in good general health as determined from recent medical history.
- 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 ≤3 mm without attachment loss.
Key exclusion criteria (18 listed)
- Subjects who are undergoing treatment for gingivitis, caries, dental plaque and sensitivity.
- Subjects are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
- Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gurunanda - Water FlosserMode of Usage: 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 Frequency: Use twice a day after brushing. Route of administration: Topical - Oral Storage Condition: Store in a cool, dry place, away from direct sunlight, and do not submerge in water. | Device | Gurunanda - Water Flosser |
| No water FlossingNo water Flossing | Other | No water Flossing |
Primary outcome
To assess the effectiveness of the test product in terms of change in plaque deposition
Time frame: Before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days)
By using Turesky Modification of the Quigley-Hein Index by Dentist or Dentist trained evaluator.
To assess the effectiveness of the test product in terms of change in plaque induced gingivitis
Time frame: Before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days)
By using Loe \& Silness Gingival Index by Dentist or Dentist trained evaluator.
1 secondary outcome
To assess the improvement in product perception questionnaire
Time frame: Baseline prior to usage of test product and on Day 01, Day 15 (±2 days), and Day 30 (±2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayan Patel study director
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gurunanda - Water Flosser and No water Flossing in people with Plaque Induced Gingivitis, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of the test product in terms of change in plaque deposition (time frame: Before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.