Status:
COMPLETED
Single Brushing Plaque Removal Efficacy of a Battery-powered Toothbrush and a Manual Toothbrush
Lead Sponsor:
Church & Dwight Company, Inc.
Conditions:
Plaque, Dental
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To evaluate and compare the plaque removal efficacy of a battery-powered toothbrush and a manual toothbrush following a single brushing.
Detailed Description
This is a single use, examiner blinded, randomized, two-period, cross-over, IRB-approved research study evaluating the single-use plaque removal efficacy of a new battery-operated toothbrush and a mar...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06126445
Start Date
November 13 2023
End Date
January 12 2024
Last Update
February 28 2024
Active Locations (1)
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1
All Sum Research Center Ltd.
Mississauga, Ontario, Canada, L5N 6J2 C