Plaque, DentalNCT06126445
Single Brushing Plaque Removal Efficacy of a Battery-powered Toothbrush and a Manual Toothbrush
A study testing Battery operated toothbrush and Manual toothbrush in people with Plaque, Dental, run by Church & Dwight Company, Inc. at 1 site in Canada.
Trial summary
To evaluate and compare the plaque removal efficacy of a battery-powered toothbrush and a manual toothbrush following a single brushing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental
- What is being tested?
- Battery operated toothbrush and Manual toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2023to 12 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dental Plaque Removal Efficacy Evaluation and Comparison of Electric Toothbrush and Manual Toothbrush
To evaluate and compare the plaque removal efficacy of a battery-powered toothbrush and a manual toothbrush following a single brushing.
Read the 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 marketed manual toothbrush. This study will accept up to 64 subjects, 18-65 years of age, in anticipation that 60 subjects will complete the study. Qualified subjects with sufficient plaque, according to Rustogi Modified Navy Plaque Index (RMNPI) will be randomly assigned to one of two sequence treatment groups.
After the pre-brushing plaque evaluation at each of the evaluation visits, subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing under supervision, in front of mirror.
- Conditions
- Plaque, Dental
- Being tested
- Battery operated toothbrush, Manual toothbrush
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battery operated toothbrushDevice
Device on plaque removal efficacy
Manual toothbrushDevice
Device on plaque removal efficacy
| Study group | Role | What they receive |
|---|---|---|
| Battery operated toothbrush | Active comparator | battery operated toothbrush Receives: Device: Battery operated toothbrush |
| Manual toothbrush | Active comparator | Manual toothbrush Receives: Device: Manual toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start13 Nov 2023
- Primary completion29 Nov 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single use, examiner blinded, randomized, two-period, cross-over
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jimmy Qaqish, Study director, All Sum Research Center Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126445
- Sponsor's protocol ID
- ST-23-U34
- Status last verified
- Feb 2024
- First submitted
- 6 Nov 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Plaque Removal Efficacy Evaluation and Comparison of Electric Toothbrush and Manual Toothbrush
- ClinicalTrials.gov ID
- NCT06126445
- Acronym / sponsor ID
- ST-23-U34
- Conditions
- Plaque, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 marketed manual toothbrush. This study will accept up to 64 subjects, 18-65 years of age, in anticipation that 60 subjects will complete the study. Qualified subjects with sufficient plaque, according to Rustogi Modified Navy Plaque Index (RMNPI) will be randomly assigned to one of two sequence treatment groups.
After the pre-brushing plaque evaluation at each of the evaluation visits, subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing under supervision, in front of mirror.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- single use, examiner blinded, randomized, two-period, cross-over
| Arm | Type | Receives |
|---|---|---|
| Battery operated toothbrush | Active comparator | Device: Battery operated toothbrushbattery operated toothbrush |
| Manual toothbrush | Active comparator | Device: Manual toothbrushManual toothbrush |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Battery operated toothbrushDevice on plaque removal efficacy | Device | Battery operated toothbrush |
| Manual toothbrushDevice on plaque removal efficacy | Device | Manual toothbrush |
Primary outcome
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
Time frame: up to 2 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmy Qaqish study director
All Sum Research Center Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battery operated toothbrush and Manual toothbrush in people with Plaque, Dental, run by Church & Dwight Company, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.