Plaque Induced GingivitisNCT06122376
Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model
A study testing U-shaped Power Toothbrush and Soft Manual Toothbrush in people with Plaque Induced Gingivitis, run by Lander Enterprises, LLC at 1 site in United States.
Trial summary
The objective of this 30 day, randomized, two group, parallel, examiner-blind clinical trial is to assess the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on plaque and gingivitis, compared to an American Dental Association (ADA) reference manual soft toothbrush. Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingivitis
- What is being tested?
- U-shaped Power Toothbrush and Soft Manual Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 14 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- generally healthy males and females at least 5 to 65 years of age.
- If under age 18, willing to provide assent to participate and consent from a parent or legal guardian prior to being entered into the study; If 18 years of age or older, is able to read, sign and receive a copy of the signed informed consent form.
- regular manual toothbrush users and able to brush their own teeth on a daily basis.
- In good health based on medical history review by the investigator.
- willing to refrain from all oral hygiene for approximately 12-16 hours prior to each study visit and discontinue eating and drinking for approximately 30 minutes prior to each study visit, with the exception of sips of water.
- Have a minimum of 18 natural teeth, in the adult dentition, with scorable facial and lingual surfaces. If under the age of 12, must have at least 12 fully erupted teeth, primary or permanent teeth. Partially erupted permanent teeth and primary teeth that are loose or in process of exfoliation will not be included in the tooth count. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, > 2 mm gingival recession will not be included in the tooth count.
- Present with a gingival index score ≥ 1.75 according to the Modified Gingival Index at Baseline, a plaque index score > 1.80 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following a 12 to 16-hour plaque accumulation period at Baseline.
- willing and able to refrain from dental treatment during the course of the study, except on an emergency basis.
Who cannot join
- history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
- Self-reported serious medical conditions.
- Self-reported as pregnant or nursing.
- Under treatment for a heart condition requiring use of pacemaker.
- Have any condition, in the opinion of the investigator, that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study?
- Require antibiotic premedication prior to dental procedures.
Show all 14Show fewer
- Have had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of screening exams.
- participated in any study involving oral care products, concurrently or within the 30 days of screening exams.
- Unwilling to discontinue use of other oral hygiene products for the duration of the study.
- Present use of any tobacco products.
- Presence of severe periodontal disease or being actively treated for periodontal disease.
- Have grossly carious, fully crowned, or extensively restored teeth.
- Have orthodontic appliances, peri/oral piercings, or removable partial dentures.
- Have significant oral soft tissue pathology based on a visual examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Safety and Efficacy of AutoBrush® 360° U-Shaped Sonic Toothbrush on Plaque and Gingivitis in a 30-Day Model
The objective of this 30 day, randomized, two group, parallel, examiner-blind clinical trial is to assess the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on plaque and gingivitis, compared to an American Dental Association (ADA) reference manual soft toothbrush. The extent of gingival abrasion and recession and oral safety will be evaluated.
Read the detailed description
This single-center, randomized, controlled, examiner-blind, 30-day parallel study will consist of Screening and Baseline visits with approximately 80 subjects (age 5-65 years) who will read and sign an informed consent form and assent form, assessed for evidence of gingivitis and plaque according to the Modified Gingival Index (MGI) and the Lobene-Soparkar Modification of Turesky Modified Quigley-Hein Plaque Index (LSPI) at Baseline, Day 15 and Day 30. Gingival recession and gingival abrasion will be measured at all visits. Subjects will be randomly assigned to one of two groups twice daily brushing with ADA accepted fluoride toothpaste and 1) two-minute brushing with ADA reference standard manual toothbrush, or 2) 30-second brushing with AutoBrush® 360° U-shaped Sonic Toothbrush.
- Conditions
- Plaque Induced Gingivitis
- Being tested
- U-shaped Power Toothbrush, Soft Manual Toothbrush
- Keywords
- gingivitis, dental plaque, Power toothbrush, manual toothbrush
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-shaped Power ToothbrushDevice
Twice daily brushing for 30 seconds with fluoride toothpaste
Soft Manual ToothbrushDevice
Twice daily brushing for two minutes with fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| U-shaped power toothbrush | Experimental | U-shaped power toothbrush with fluoride toothpaste Receives: Device: U-shaped Power Toothbrush |
| Manual Toothbrush | Placebo comparator | soft manual toothbrush with fluoride toothpaste Receives: Device: Soft Manual Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingivitis: Modified Gingival Index
Gingival Inflammation, assessed on a 5-point scale (0 to 4), will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of all scorable teeth using criteria: 0 = Normal (absence of inflammation), 1 = Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 = Mild inflammation of the entire gingival unit; 3 = Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 = Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Measured: Whole mouth mean change from Baseline in MGI scores at Day 30.
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.
Measured: Whole mouth mean change in LSPI scores at Day 30, immediate post-brushing (Pre- to Post-Brushing scores)
Secondary outcomes (4)
Gingivitis
Whole mouth MGI, Gumline MGI, Proximal, Mean distal score of the last posterior tooth in each quadrant.
Measured: Change from Baseline at Day 15 and Day 30
Plaque
LSPI: Whole mouth, Gumline, Proximal, distal score of the last posterior tooth in each quadrant.
Measured: Change from Baseline at Day 15 and Day 30
Safety: gingival recession
Gingival recession measurements (mm) will be carried out at six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual). Recession will be measured as the visible distance from the cemento-enamel junction (CEJ) to the gingival margin.
Measured: Changes from Baseline at Day 15 and Day 30
Safety: gingival abrasion
Gingival Abrasion will be assessed with a 2-tone disclosing solution to help visualize abraded areas of the oral epithelium. Gingival tissues of each tooth will be divided into 3 areas on both the facial and lingual surfaces, as illustrated in Fig. 1: marginal (cervical free gingiva), interdental (papillary free gingiva) and mid-gingival (attached gingiva). If abrasion is present, the site will be recorded as small (≤2 mm), medium (3-5 mm) and large (>5 mm). If no abrasion is present, the site will be recorded as "0".
Measured: Changes from Baseline at Day 15 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start31 May 2023
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced GingivitisStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lander Enterprises, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery L Milleman, Principal investigator, Salus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122376
- Sponsor's protocol ID
- AB-GBP-2023-02
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 8 Nov 2023
- 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 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Efficacy of AutoBrush® 360° U-Shaped Sonic Toothbrush on Plaque and Gingivitis in a 30-Day Model
- ClinicalTrials.gov ID
- NCT06122376
- Acronym / sponsor ID
- AB-GBP-2023-02
- Conditions
- Plaque Induced Gingivitis
- Keywords
- gingivitis, dental plaque, Power toothbrush, manual toothbrush
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lander Enterprises, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 8 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.
The objective of this 30 day, randomized, two group, parallel, examiner-blind clinical trial is to assess the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on plaque and gingivitis, compared to an American Dental Association (ADA) reference manual soft toothbrush. The extent of gingival abrasion and recession and oral safety will be evaluated.
Detailed description
This single-center, randomized, controlled, examiner-blind, 30-day parallel study will consist of Screening and Baseline visits with approximately 80 subjects (age 5-65 years) who will read and sign an informed consent form and assent form, assessed for evidence of gingivitis and plaque according to the Modified Gingival Index (MGI) and the Lobene-Soparkar Modification of Turesky Modified Quigley-Hein Plaque Index (LSPI) at Baseline, Day 15 and Day 30. Gingival recession and gingival abrasion will be measured at all visits. Subjects will be randomly assigned to one of two groups twice daily brushing with ADA accepted fluoride toothpaste and 1) two-minute brushing with ADA reference standard manual toothbrush, or 2) 30-second brushing with AutoBrush® 360° U-shaped Sonic Toothbrush.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U-shaped power toothbrush | Experimental | Device: U-shaped Power ToothbrushU-shaped power toothbrush with fluoride toothpaste |
| Manual Toothbrush | Placebo comparator | Device: Soft Manual Toothbrushsoft manual toothbrush with fluoride toothpaste |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- generally healthy males and females at least 5 to 65 years of age.
- If under age 18, willing to provide assent to participate and consent from a parent or legal guardian prior to being entered into the study; If 18 years of age or older, is able to read, sign and receive a copy of the signed informed consent form.
- regular manual toothbrush users and able to brush their own teeth on a daily basis.
- In good health based on medical history review by the investigator.
- willing to refrain from all oral hygiene for approximately 12-16 hours prior to each study visit and discontinue eating and drinking for approximately 30 minutes prior to each study visit, with the exception of sips of water.
Key exclusion criteria (14 listed)
- history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
- Self-reported serious medical conditions.
- Self-reported as pregnant or nursing.
- Under treatment for a heart condition requiring use of pacemaker.
- Have any condition, in the opinion of the investigator, that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study?
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 |
|---|---|---|
| U-shaped Power ToothbrushTwice daily brushing for 30 seconds with fluoride toothpaste | Device | U-shaped power toothbrush |
| Soft Manual ToothbrushTwice daily brushing for two minutes with fluoride toothpaste | Device | Manual Toothbrush |
Primary outcome
Gingivitis: Modified Gingival Index
Time frame: Whole mouth mean change from Baseline in MGI scores at Day 30.
Gingival Inflammation, assessed on a 5-point scale (0 to 4), will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of all scorable teeth using criteria: 0 = Normal (absence of inflammation), 1 = Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 = Mild inflammation of the entire gingival unit; 3 = Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 = Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index
Time frame: Whole mouth mean change in LSPI scores at Day 30, immediate post-brushing (Pre- to Post-Brushing scores)
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.
4 secondary outcomes
Gingivitis
Time frame: Change from Baseline at Day 15 and Day 30
Plaque
Time frame: Change from Baseline at Day 15 and Day 30
Safety: gingival recession
Time frame: Changes from Baseline at Day 15 and Day 30
Safety: gingival abrasion
Time frame: Changes from Baseline at Day 15 and Day 30
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 Nov 2023.
- 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.
Jeffery L Milleman principal investigator
Salus Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U-shaped Power Toothbrush and Soft Manual Toothbrush in people with Plaque Induced Gingivitis, 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 8 inclusion and 14 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 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Gingivitis: Modified Gingival Index (time frame: Whole mouth mean change from Baseline in MGI scores at Day 30.). The study lists 2 primary outcomes in all. 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 Nov 2023.