Clinical trial NCT04804670: To Compare the Effectiveness of Three Self-care Oral Hygiene Regimens
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Water Pik, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bleeding on Probing
timeFrame: 4 weeks
measure: Modified Gingival Index
timeFrame: 4 weeks
Secondary outcomes:
measure: Rustogi Modification of the Navy Plaque Index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: All Sum Research Center
state: Ontario
Study officials:
affiliation: All Sum Research Center Ltd.
name: Jimmy G Qaqish, BSc
role: STUDY_DIRECTOR
References: