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CompletedNCT04804670Updated Oct 11, 2021

To Compare the Effectiveness of Three Self-care Oral Hygiene Regimens

An interventional study of Power device A and Power device B in Gingivitis, sponsored by Water Pik, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-11.

Sponsored by Water Pik, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally, plaque removal will be evaluated after a single use (part 1) and over 4 weeks (part 2).

Read the detailed description

Data will be analyzed and reported as mean. The target population is approximately 105 healthy adult volunteers. there will be three groups with 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, subjects will be randomly assigned in a 1:1:1 ratio.

With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%.

The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks.

Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the Modified Gingival index after 2 (+/- 2 days) and 4 weeks (+/- 2 days). Reduction in Rustogi Modification of Navy Plaque Index pre \& Post, 2 weeks (+/- 2 days) and 4 weeks (+/- 2 days).

Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed-up.

Subjects will complete a questionnaure at the completion of the study.

02

Conditions studied

  • Gingivitis

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03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 105 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Water Pik, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Provided written informed consent prior to being entered into the study
  • Have at least twenty (20) natural teeth (5 evaluable teeth in each quadrant) with scorable facial and lingual surfaces as determined by examiner
  • No tobacco use or other substance via the mouth including but not limited to cigarettes, cigars, smokeless tobacco hookah, cannabis, snuff, chew, or vaping electronic cigarettes
  • Have a minimum of 50% bleeding on probing sites (6 sites per tooth, total of 120 - 168 total sites)
  • Have probing depths \</= 4 mm
  • Have a mean baseline gingival index score of >/= to 1.75 as determined by the Modified Gingival Index.
  • Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures any time during the study
  • Agree to abstain from the use of chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at home use) and all other oral hygiene aids other than the study procedures for the duration of the study
  • Agree to refrain from all oral hygiene on morning of each evaluation visit
  • Agree to comply with the conditions ad schedule of the study

Exclusion criteria

Exclusion Criteria:

  • Physical limitations or restrictions that might preclude normal tooth brushing.
  • Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.
  • Heavy supra- or subgingival calculus that might interfere with evaluations as determined by the examiner.
  • Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the examiner.
  • Conditions requiring antibiotic treatment prior to dental procedures.
  • History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable disease, (e.g. cardiomyopathy, immunocompromised).
  • Subjects with several fully crowned or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures.
  • Treatment with antibiotics within 6 months before the baseline examination, or a condition that is likely to require antibiotic treatment over the course of the trial.
  • Chronic treatment (2-weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, Coumadin, nonsteroidal anti-inflammatory drugs, and aspirin (325 mg)) within the month before the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment.
  • Have severe periodontal disease or being actively treated for periodontal disease.
  • Having history of early-onset periodontitis or acute necrotizing ulcerative gingivitis.
  • Concomitant periodontal therapy other than prophylaxis in the last 3 months.
  • Professional prophylaxis within 1 month prior to the baseline clinical evaluation.
  • Subjects who participated in a gingivitis study in the past month.
  • History of significant adverse event following use of oral hygiene products such as toothpastes and mouth rinses.
  • Self-reported pregnancy or lactating women or planning to become pregnant during the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Sonic-Floss toothbrush and small brush head

    sonic toothbrush used for 2 minutes and water flosser used for 1 minute

    Device: Power device A

  • Experimental
    Sonic-Floss toothbrush and full size brush head

    sonic toothbrush used for 2 minutes and water flosser used for 1 minute

    Device: Power device B

  • Active comparator
    Manual brushing and flossing

    American Dental Association standard manual toothbrush used for 2 minutes and dental floss all teeth

    Device: Routine Oral Hygiene

Interventions

  • DevicePower device A

    Oral hygiene regimen completed daily

  • DevicePower device B

    Oral hygiene regimen completed daily

  • DeviceRoutine Oral Hygiene

    Oral hygiene regimen completed daily

06

What researchers measure

Primary outcomes

  1. Bleeding on Probing

    Binary measure of present = 1 or absent =0. Mean score is determined by adding the total number of sites with bleeding (six per tooth) and dividing by the total evaluable sites.

    Time frame: 4 weeks

  2. Modified Gingival Index

    Index uses a 0 - 4 point scale

    Time frame: 4 weeks

Secondary outcomes

  1. Rustogi Modification of the Navy Plaque Index

    Each tooth is scored using 9 sections for the facial and lingual surfaces.

    Time frame: 4 weeks

07

Study locations

1 site
  • All Sum Research Center
    Mississauga, Ontario L5N 6J2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04804670
Lead sponsor
Water Pik, Inc.
Responsible party
Sponsor
First posted
Mar 18, 2021
Start date
Oct 19, 2020
Primary completion
Nov 20, 2020
Completion
Jan 8, 2021
Last update
Oct 11, 2021

Study contacts

Jimmy G Qaqish, BSc
study director · All Sum Research Center Ltd.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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