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

NCT06292611 | Completed

• 1 other identifier: ST-23-U35
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Devices, Home Care

Outcome Measures

Primary Outcomes (1)

• Extrinsic Stain

  Macpherson Modification of the Lobene Stain Index (MLSI)

  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 extrinsic stain removal efficacy

Battery operated toothbrush

Manual toothbrush DEVICE

Device on extrinsic stain 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:

• 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;
• 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;
• 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;
• 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;
• Have had a dental prophylaxis within the past 18 months, but not within the past 3 months;
• 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.
• Agree to comply with the conditions and schedule of the study; and
• Approximately 50% of study participants will be regular power brush users, with the remaining 50% of study participants regular manual brush users.

You may not qualify if:

• 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;
• Have had prior significant adverse effects following use of oral hygiene products;
• 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;
• 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;
• 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;
• 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);
• Are nursing (breast-feeding) or pregnant;
• 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;
• Have participated in tooth bleaching or whitening dentifrice trials within the last three months; and
• Have had professional or at-home bleaching during the last 6 months.

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

Study Officials

• Jeffery L Milleman, DDS, MPA

  Salus Research, Inc.

  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: February 27, 2024
• First Posted: March 5, 2024
• Study Start: November 27, 2023
• Primary Completion: December 12, 2023
• Study Completion: January 25, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)