Single Brushing Plaque Removal Efficacy of a Battery-powered Toothbrush and a Manual Toothbrush

NCT06126445 | Completed

• 1 other identifier: ST-23-U34
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the plaque removal efficacy of a battery-powered toothbrush and a manual toothbrush following a single brushing.

Conditions

Plaque, Dental

Outcome Measures

Primary Outcomes (1)

• Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal

  Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured. Scale used is Rustogi Modification of the Navy Plaque Index (RMNPI). Up to 504 sites scored in the mouth, with each score a 0 or 1, and subject scores an average over all sites measured. Minimum score of 0 and maximum score of 1. For each timepoint, a larger score means more plaque. For reduction from baseline, a larger score means a greater reduction in plaque.

  up to 2 weeks

Study Arms (2)

Battery operated toothbrush

ACTIVE COMPARATOR

battery operated toothbrush

Device: Battery operated toothbrush

Manual toothbrush

ACTIVE COMPARATOR

Manual toothbrush

Device: Manual toothbrush

Interventions

Battery operated toothbrush DEVICE

Device on plaque removal efficacy

Battery operated toothbrush

Manual toothbrush DEVICE

Device on plaque removal efficacy

Manual toothbrush

Eligibility Criteria

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

You may qualify if:

• Have provided a signed and dated informed consent document indicating that you have been informed of all pertinent aspects of the study before any assessments are performed. You will receive a copy of the signed informed consent.
• Be between 18 and 65 years of age (inclusive), male or female.
• Able to brush their own teeth on a daily basis.
• Be in good health based on medical history review by the Principal Investigator.
• Have a minimum of at least 18 natural, gradable teeth.
• Have a mean full-mouth pre-brushing plaque score (Rustogi Modification of the Navy Plaque Index, RMNPI) of ≥ 0.50 at evaluation visits 2 \& 3.
• Have agreed to refrain from use of all oral hygiene products (i.e. floss, mouthwash, etc.), other than the toothbrush and toothpaste supplied, for the duration of the study including the acclimation periods.
• Have agreed to refrain from all oral hygiene and chewing gum for approximately 12-16 hours and refrain from eating, drinking, smoking and chewing gum for approximately 4 hours prior to Visits 2 \& 3.
• Have agreed not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study.
• Approximately 50% of subjects will be regular electric toothbrush users and 50% of subjects will be regular manual toothbrush users.
• Have agreed to comply with the conditions and schedule of the study.

You may not qualify if:

• Have any physical limitations or restrictions which might preclude normal tooth brushing.
• Have to be premedicated prior to dental treatment.
• Have evidence of poor oral hygiene or rampant dental caries or calculus deposits that may interfere with plaque assessments.
• Have evidence of major oral hard or soft tissue lesions or trauma at Baseline.
• Have fixed or removable orthodontic appliances.
• Have received a dental prophylaxis within a month prior to Visit 1.
• Have a history of a significant adverse event, allergy, or irritation that was due to oral hygiene products.
• Have participated in another dental research study within 4 weeks prior to Visit 1.
• Therapy with any medications, currently or within the last 28 days, which might interfere with the outcome of the study by affecting tissue condition, or salivation, particularly chronic therapy or long-term use, as determined by the investigator.
• Existing serious medical condition or transmittable disease as determined by the Principal Investigator after review of the medical history form. These will include but not be limited to, hepatitis, tuberculosis, AIDS.

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

All Sum Research Center Ltd.

Mississauga, Ontario, L5N 6J2 C, Canada

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jimmy Qaqish

  All Sum Research Center Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Examiner blinded to toothbrush used.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single use, examiner blinded, randomized, two-period, cross-over

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: November 13, 2023
• Primary Completion: November 29, 2023
• Study Completion: January 12, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)