Dental PlaqueNCT06300073
Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children
A study testing Experimental: U-shaped Power Toothbrush in people with Dental Plaque, run by Lander Enterprises, LLC at 1 site in United States.
Trial summary
The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Experimental: U-shaped Power Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2023to 17 Feb 2023
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Having a history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
- Having self-reported serious medical conditions.
- Being under treatment for a heart condition requiring use of a pacemaker.
- Having anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- Having had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of screening exams.
Show all 11Show fewer
- Having participated in any study involving oral care products, concurrently or within the 30 days of screening exams.
- Presence of severe periodontal disease or being actively treated for periodontal disease.
- Having grossly carious, fully crowned, or extensively restored teeth.
- Having orthodontic appliances, peri/oral piercings, or removable partial dentures.
- Having significant oral soft tissue pathology based on a visual examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plaque Removal Efficacy of AutoBrush®, a 360 Degree Sonic Power Toothbrush in Children
The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush.
Read the detailed description
Up to 22 healthy children (5-8 years old) will be enrolled in a single-center, single-use, randomized, two-period, IRB approved cross-over study. Subjects will be randomly assigned to one of two treatment sequences: 1) brush two minutes with marketed children's manual toothbrush (MTB) or 2) brush 30 seconds with AutoBrush® 360° Sonic Toothbrush (AB) and fluoride toothpaste. Qualified subjects will have pre-brushing supragingival plaque levels ≥ 1.8 according to the Lobene-Soparkar Modified Turesky Modification of the Quigley-Hein Plaque Index (PI), following 12-16 hours plaque accumulation period. Under parent's supervision, subjects brushed at home with their assigned toothbrush, twice daily during a 2-day familiarization period. After refraining (12-16 hours) from oral hygiene, subjects returned for plaque assessment, supervised use of their assigned toothbrush and a post-brushing plaque evaluation. Subjects were given the second toothbrush to begin the next 2-day familiarization period and second period evaluation procedures. Analysis of covariance (ANCOVA) will be used for single-use brushing PI models to assess whole mouth and 8 other hard-to-reach tooth sites.
- Conditions
- Dental Plaque
- Being tested
- Experimental: U-shaped Power Toothbrush, Placebo Comparator: Soft Manual Toothbrush
- Keywords
- gingivitis, toothbrush
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: U-shaped Power ToothbrushDevice
Twice daily brushing for 30 seconds with fluoride toothpaste
Placebo Comparator: Soft Manual ToothbrushDevice
Twice daily brushing for 2 minutes with fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| AutoBrush U-shaped power toothbrush, then Manual Toothbrush | Experimental | Participants first received the AutoBrush U-shaped power toothbrush with fluoride toothpaste for a single brushing use for 30 seconds; after a 2-day washout period, participants received the ADA reference manual toothbrush for a single brushing use for 2 minutes. Receives: Device: Experimental: U-shaped Power Toothbrush; Device: Placebo Comparator: Soft Manual Toothbrush |
| Manual Toothbrush | Experimental | Participants first received the ADA reference manual toothbrush for a single brushing use for 2 minutes; after a 2-day washout period, participants received the AutoBrush U-shaped power toothbrush with fluoride toothpaste for a single brushing use for 30 seconds. Receives: Device: Experimental: U-shaped Power Toothbrush; Device: Placebo Comparator: Soft 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 tooth surfaces of the whole mouth.
Supragingival dental plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index
Plaque will be disclosed using a red disclosing solution and each tooth will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual), according to the criteria noted below:
0 = No plaque.
- = Separate flecks or discontinuous band of plaque at the gingival (cervical) margin.
- = Thin (up to 1 mm), continuous band of plaque at the gingival margin.
- = Band of plaque wider than 1 mm but less than 1/3 of tooth surface area.
- = Plaque covering 1/3 or more, but less than 2/3 of tooth surface area.
- = Plaque covering 2/3 or more of tooth surface area.
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 posted8 Mar 2024
- Study start14 Feb 2023
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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, randomized, two-period, cross-over study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lander Enterprises, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300073
- Sponsor's protocol ID
- AB-360-001-2022
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Removal Efficacy of AutoBrush®, a 360 Degree Sonic Power Toothbrush in Children
- ClinicalTrials.gov ID
- NCT06300073
- Acronym / sponsor ID
- AB-360-001-2022
- Conditions
- Dental Plaque
- Keywords
- gingivitis, toothbrush
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Lander Enterprises, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 8 Mar 2024 (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.
The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush.
Detailed description
Up to 22 healthy children (5-8 years old) will be enrolled in a single-center, single-use, randomized, two-period, IRB approved cross-over study. Subjects will be randomly assigned to one of two treatment sequences: 1) brush two minutes with marketed children's manual toothbrush (MTB) or 2) brush 30 seconds with AutoBrush® 360° Sonic Toothbrush (AB) and fluoride toothpaste. Qualified subjects will have pre-brushing supragingival plaque levels ≥ 1.8 according to the Lobene-Soparkar Modified Turesky Modification of the Quigley-Hein Plaque Index (PI), following 12-16 hours plaque accumulation period. Under parent's supervision, subjects brushed at home with their assigned toothbrush, twice daily during a 2-day familiarization period. After refraining (12-16 hours) from oral hygiene, subjects returned for plaque assessment, supervised use of their assigned toothbrush and a post-brushing plaque evaluation. Subjects were given the second toothbrush to begin the next 2-day familiarization period and second period evaluation procedures. Analysis of covariance (ANCOVA) will be used for single-use brushing PI models to assess whole mouth and 8 other hard-to-reach tooth sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single-use, randomized, two-period, cross-over study
| Arm | Type | Receives |
|---|---|---|
| AutoBrush U-shaped power toothbrush, then Manual Toothbrush | Experimental | Device: Experimental: U-shaped Power Toothbrush, Device: Placebo Comparator: Soft Manual ToothbrushParticipants first received the AutoBrush U-shaped power toothbrush with fluoride toothpaste for a single brushing use for 30 seconds; after a 2-day washout period, participants received the ADA reference manual toothbrush for a single brushing use for 2 minutes. |
| Manual Toothbrush | Experimental | Device: Experimental: U-shaped Power Toothbrush, Device: Placebo Comparator: Soft Manual ToothbrushParticipants first received the ADA reference manual toothbrush for a single brushing use for 2 minutes; after a 2-day washout period, participants received the AutoBrush U-shaped power toothbrush with fluoride toothpaste for a single brushing use for 30 seconds. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Having a history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
- Having self-reported serious medical conditions.
- Being under treatment for a heart condition requiring use of a pacemaker.
- Having anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- Having had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of screening exams.
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 |
|---|---|---|
| Experimental: U-shaped Power ToothbrushTwice daily brushing for 30 seconds with fluoride toothpaste | Device | AutoBrush U-shaped power toothbrush, then Manual Toothbrush, Manual Toothbrush |
| Placebo Comparator: Soft Manual ToothbrushTwice daily brushing for 2 minutes with fluoride toothpaste | Device | AutoBrush U-shaped power toothbrush, then Manual Toothbrush, Manual Toothbrush |
Primary outcome
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 tooth surfaces of the whole mouth.
Time frame: Up to 2 weeks
Supragingival dental plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index Plaque will be disclosed using a red disclosing solution and each tooth will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual), according to the criteria noted below: 0 = No plaque. 1. = Separate flecks or discontinuous band of plaque at the gingival (cervical) margin. 2. = Thin (up to 1 mm), continuous band of plaque at the gingival margin. 3. = Band of plaque wider than 1 mm but less than 1/3 of tooth surface area. 4. = Plaque covering 1/3 or more, but less than 2/3 of tooth surface area. 5. = Plaque covering 2/3 or more of tooth surface area.
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 8 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: U-shaped Power Toothbrush in people with Dental Plaque, run by Lander Enterprises, LLC at 1 site in United States.
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 0 inclusion and 11 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 8 Mar 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 United States. 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 Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all tooth surfaces of the whole mouth. (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 8 Mar 2024.