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

October 4, 2021 updated by: Water Pik, Inc.

To Determine the Effectiveness of a Sonic Toothbrush and Interdental Device With Different Toothbrush Designs to Brushing and Flossing on Plaque, Gingival Bleeding and Inflammation: a 4-week Randomized Controlled Trial

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).

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sonic-Floss toothbrush and small brush head
sonic toothbrush used for 2 minutes and water flosser used for 1 minute
Oral hygiene regimen completed daily
Experimental: Sonic-Floss toothbrush and full size brush head
sonic toothbrush used for 2 minutes and water flosser used for 1 minute
Oral hygiene regimen completed daily
Active Comparator: Manual brushing and flossing
American Dental Association standard manual toothbrush used for 2 minutes and dental floss all teeth
Oral hygiene regimen completed daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on Probing
Time Frame: 4 weeks
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.
4 weeks
Modified Gingival Index
Time Frame: 4 weeks
Index uses a 0 - 4 point scale
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rustogi Modification of the Navy Plaque Index
Time Frame: 4 weeks
Each tooth is scored using 9 sections for the facial and lingual surfaces.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Jimmy G Qaqish, BSc, All Sum Research Center Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Actual)

November 20, 2020

Study Completion (Actual)

January 8, 2021

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 28SFTBF2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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