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CompletedNCT06292611Updated Mar 5, 2024

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

An interventional study of Battery operated toothbrush and Manual toothbrush in Dental Devices, Home Care, sponsored by Church & Dwight Company, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by Church & Dwight Company, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2023, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dental Devices, Home Care
03

In context

Lead sponsor

Church & Dwight Company, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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;
  3. Present with adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect) and continue to meet the inclusion criteria and not fall into the categories of exclusion during the period of the study;
  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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
102 participants (actual)

Study arms

  • Active comparator
    Battery operated toothbrush

    Battery operated toothbrush

    Device: Battery operated toothbrush

  • Active comparator
    Manual toothbrush

    Manual toothbrush

    Device: Manual toothbrush

Interventions

  • DeviceBattery operated toothbrush

    Device on extrinsic stain removal efficacy

  • DeviceManual toothbrush

    Device on extrinsic stain removal efficacy

06

What researchers measure

Primary outcomes

  1. Extrinsic Stain

    Macpherson Modification of the Lobene Stain Index (MLSI)

    Time frame: 2 weeks

07

Study locations

1 site
  • Salus Research, Inc.
    Fort Wayne, Indiana 46825, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06292611
Lead sponsor
Church & Dwight Company, Inc.
Responsible party
Sponsor
First posted
Mar 5, 2024
Start date
Nov 27, 2023
Primary completion
Dec 12, 2023
Completion
Jan 25, 2024
Last update
Mar 5, 2024

Study contacts

Jeffery L Milleman, DDS, MPA
study director · Salus Research, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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