Clinical trial NCT05766995: Evaluation of 3 Oral Self-care Regimens on Clinical Signs of Inflammation and Plaque
Official title: Efficacy of Three Oral Self-care Regimens on Clinical Parameters of Inflammation and Plaque: Part 1 - a Four Week Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Water Pik, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare three different oral hygiene regimens on changes in gum tissue appearance, gum bleeding, and plaque scores.

Detailed description: The goal of this clinical trial was to compare the effect of different battery powered water in and adult population with mild to moderate gingivitis. The main questions it aims to answer are:

* Is there a difference between the two water flosser devices on gum bleeding scores?
* Is there a difference between the two water flosser devices on plaque accumulation and removal?
* Is there a difference between the two water flosser devices on signs of gingivitis?

Researchers will compare the two groups using a water flosser (experimental) to see how it compares to traditional brushing and flossing (control).

Eligibility criteria: Inclusion Criteria:

* Have provided written informed consent prior to being entered into the study.
* Be between 18 and 75 years of age, male or female.
* Have at least twenty (20) natural teeth (5 evaluable in each quadrant) with scorable facial and lingual surfaces as determined by the clinical examiner.
* Nonsmoking (assessed as \< 1 cigarette every day for at least a year).
* Have a mean baseline plaque index score of ≥0.60 as determined by the Rustogi Modification of the Navy Plaque Index (RMNPI).
* Have a mean baseline gingival index score of ≥1.75 as determined by the Modified Gingival Index (MGI).
* Have a mean bleeding on probing score of 50%.
* Have probe readings ≤4 mm.
* 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 other than the study procedures for the duration of the study.
* Agree to refrain from all oral hygiene on the morning of each evaluation visit and to refrain from eating, drinking or chewing gum for 4 hours prior to each evaluation visit.
* Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

* Physical limitations or restrictions that might preclude normal use of devices.
* 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.
* Supra- or subgingival calculus that might interfere with evaluations as determined by the clinical examiner.
* Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the clinical 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. COVID-19, AIDS).
* Subjects with grossly carious, fully crowned, or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures.
* Treatment with antibiotics within the 1-month period 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 1- month of the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment.
* Have moderate to severe periodontal disease or being actively treated for periodontal disease.
* Concomitant periodontal therapy other than prophylaxis in the last 6 months.
* Professional prophylaxis within 1 month prior to the baseline clinical evaluation.
* Subjects who participate 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.
* Subjects who are allergic to any ingredients in Crest® Cavity Protection or Colgate® Cavity Protection toothpaste.
* Self-reported pregnancy or lactating women since hormonal changes can exaggerate gingival response to dental plaque.

Primary outcomes:
measure: Bleeding on probing
timeFrame: 4 weeks
Secondary outcomes:
measure: Modified gingival index
timeFrame: 4 weeks
measure: Rustogi Modification of Navy Plaque Index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: All Sum Research Center Ltd.
state: Ontario
Study officials:
affiliation: Water Pik, Inc.
name: Deborah Mancinelli Lyle
role: PRINCIPAL_INVESTIGATOR
References: