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

NCT04804670 | Completed

• 1 other identifier: 28SFTBF2020
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (2)

• 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.

  4 weeks

• Modified Gingival Index

  Index uses a 0 - 4 point scale

  4 weeks

Secondary Outcomes (1)

• Rustogi Modification of the Navy Plaque Index

  4 weeks

Study Arms (3)

Sonic-Floss toothbrush and small brush head

EXPERIMENTAL

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

Device: Power device A

Sonic-Floss toothbrush and full size brush head

EXPERIMENTAL

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

Device: Power device B

Manual brushing and flossing

ACTIVE COMPARATOR

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

Device: Routine Oral Hygiene

Interventions

Power device A DEVICE

Oral hygiene regimen completed daily

Sonic-Floss toothbrush and small brush head

Power device B DEVICE

Oral hygiene regimen completed daily

Sonic-Floss toothbrush and full size brush head

Routine Oral Hygiene DEVICE

Oral hygiene regimen completed daily

Manual brushing and flossing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Water Pik, Inc.: lead

Study Sites (1)

All Sum Research Center

Mississauga, Ontario, L5N 6J2, Canada

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jimmy G Qaqish, BSc

  All Sum Research Center Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: March 18, 2021
• Study Start: October 19, 2020
• Primary Completion: November 20, 2020
• Study Completion: January 8, 2021
• Last Updated: October 11, 2021

Record last verified: 2020-11

Locations

CA (1)