Evaluation of 3 Oral Self-care Regimens on Clinical Signs of Inflammation and Plaque

NCT05766995 | Completed

• 1 other identifier: 2021-WP-1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Bleeding on probing

  Bleeding recorded on 6 sites per tooth within 30 seconds of instrumentation. 0 = no bleeding, 1= bleeding. Bleeding determined by number of sites bleeding divided by total number of sites = percent bleeding

  4 weeks

Secondary Outcomes (2)

• Modified gingival index

  4 weeks

• Rustogi Modification of Navy Plaque Index

  4 weeks

Study Arms (3)

Manual toothbrush and water flosser with standard jet tip

EXPERIMENTAL

Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening

Device: Waterpik Water Flosser

Manual toothbrush and water flosser with targeted jet tip

EXPERIMENTAL

Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening

Device: Oral-B Water Flosser

Manual toothbrush and dental floss

ACTIVE COMPARATOR

Brush with a standard ADA manual toothbrush twice daily followed by dental flossing once in the evening

Device: Waxed Dental Floss

Interventions

Waterpik Water Flosser DEVICE

A pulsating water flosser and jet tip designed to clean between the teeth and below the gingival margin.

Also known as: dental water jet, oral irrigator

Manual toothbrush and water flosser with standard jet tip

Oral-B Water Flosser DEVICE

A water flosser and specialized tip that delivers water with microbubbles of air

Also known as: dental water jet, oral irrigator

Manual toothbrush and water flosser with targeted jet tip

Waxed Dental Floss DEVICE

Nylon string used to clean between the teeth manually

Manual toothbrush and dental floss

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Water Pik, Inc.: lead

Study Sites (1)

All Sum Research Center Ltd.

Mississauga, Ontario, L5N 6J2, Canada

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Deborah Mancinelli Lyle

  Water Pik, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: March 13, 2023
• Study Start: August 3, 2021
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: March 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)