Two Week Cumulative Extrinsic Stain Removal of a Battery-powered Toothbrush and a Manual Toothbrush

NCT ID: NCT06292611

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2024-01-25

Brief Summary

To evaluate and compare the extrinsic stain removal efficacy of a battery-powered toothbrush and a manual toothbrush following two weeks of brushing.

Detailed Description

This is a two week, examiner blinded, randomized, parallel group, IRB-approved research study evaluating the extrinsic stain removal efficacy of a new battery-operated toothbrush and a marketed manual toothbrush. This study will accept up to 110 subjects, 18-65 years of age, in anticipation that 50 subjects per treatment group will complete the study. Qualified subjects with sufficient extrinsic stain, according to Macpherson Modified Lobene Stain Index (MLSI) will be randomly assigned to one of two treatment groups.

Subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing twice a day for two weeks.

Conditions

Dental Devices, Home Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Battery operated toothbrush

Battery operated toothbrush

Group Type: ACTIVE_COMPARATOR

Battery operated toothbrush

Intervention Type: DEVICE

Device on extrinsic stain removal efficacy

Manual toothbrush

Manual toothbrush

Group Type: ACTIVE_COMPARATOR

Manual toothbrush

Intervention Type: DEVICE

Device on extrinsic stain removal efficacy

Interventions

Battery operated toothbrush

Device on extrinsic stain removal efficacy

Intervention Type: DEVICE

Manual toothbrush

Device on extrinsic stain removal efficacy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Be between the ages of 18 and 65, ambulatory and in good general health as determined by the Study Examiner, based upon clinical observation and the Medical/Dental History;

2. Be able to understand and sign the Informed Consent, complete a Medical History form, understand and comply with all study directions, and be available for all exam periods;

4. Have at least 16 natural teeth in a good state of repair and at least 8 of the 12 anterior teeth free from full crowns or extensive restorations;

5. Have a mean Macpherson Modified Lobene Stain Index (MLSI) score of ≥ 1.5 on the labial surfaces of at least 8 of 12 anterior teeth;

6. Have had a dental prophylaxis within the past 18 months, but not within the past 3 months;

7. Agree to refrain from using all oral care products (other dentifrices and toothbrushes, dental floss, and mouth rinses) other than their assigned products for the duration of the study.

8. Agree to comply with the conditions and schedule of the study; and

9. Approximately 50% of study participants will be regular power brush users, with the remaining 50% of study participants regular manual brush users.

Exclusion Criteria

1. Have a history of serious medical conditions or transmittable diseases including but not limited to COVID-19, active hepatitis, heart irregularities, conditions requiring pre-medication for dental procedures, rheumatic heart disease, untreated diabetes mellitus, cirrhosis, leukemia, phenylketonuria, renal disease, sarcoidosis, tuberculosis, bleeding disorder, vascular disease, AIDS, history of drug allergies or idiosyncrasies, or any other medical condition that may preclude successful participation in the trial, at the discretion of the Study Examiner;

2. Have had prior significant adverse effects following use of oral hygiene products;

3. Have the presence of orthodontic bands, retainers, fixed appliances, large restorations, or removable partial dentures, which may interfere with clinical assessments of the evaluable teeth;

4. Show evidence of neglected dental health in need of prompt professional attention (i.e. gross calculus deposits or rampant caries), significant oral soft tissue pathology, systemically-related gingival enlargement, generalized recession, tissue damage due to ill-fitting appliances or restorations or extreme crowding or overlapping of teeth;

5. Have moderate/advanced periodontitis (ADA Class III or IV), e.g. more than two teeth with periodontal pockets >4 mm as evidenced by purulent exudate, tooth mobility, and other signs indicating that the integrity of the data collected might be compromised;

6. Have medication therapy that is current and ongoing or within the past 4 weeks, which might interfere with the outcome of the study by affecting oral tissue condition, salivation, or stain formation (particularly chronic long-term medication therapy);

7. Are nursing (breast-feeding) or pregnant;

8. Present at baseline with any reported sensory reactions, observed gum irritation or any condition that would interfere with subsequent clinical assessments, or subjects with a history of allergy to oral care products, severe oral cavity sensitivity, or excessive oral irritation;

9. Have participated in tooth bleaching or whitening dentifrice trials within the last three months; and

10. Have had professional or at-home bleaching during the last 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Church & Dwight Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffery L Milleman, DDS, MPA

Role: STUDY_DIRECTOR

Salus Research, Inc.

Locations

Salus Research, Inc.

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

ST-23-U35

Identifier Type: -

Identifier Source: org_study_id