Plaque, DentalNCT04681885
Evaluation of Toothbrush Bristles in Plaque Reduction
A study testing Tapered bristles A, Tapered bristles B and End rounded bristles in people with Plaque, Dental and Gingivitis, run by Sunstar Americas at 1 site in United States.
Trial summary
The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental, Gingivitis
- What is being tested?
- Tapered bristles A, Tapered bristles B and End rounded bristles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2021to 17 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Individuals may be included in the study if they meet all of the following inclusion criteria:
- Must have read, understood and signed an informed consent prior to being entered into the study
- Must be 18 to 70 years of age, male or female
- Have at least 20 natural or restored teeth
- Must have average Plaque Index of Ramfjord teeth at baseline greater than 2(Quigley and Hein) at screening
- Agree 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
- Agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the appointment in the study
- Agree to abstain from the use of any dental products other than those provided in the study
- Agree to comply with the conditions and schedule of the study
Exclusion Criteria: Individuals are not eligible for participation in this study if any of the following are noted:
- Physical limitations or restrictions that might preclude normal tooth brushing
- Evidence of gross oral pathology
- Presence of severe gingivitis with 30 or more sites showing bleeding on probing
- Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner
- Chronic disease with concomitant oral manifestations
- Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months
- Currently using bleaching trays
- Eating disorders
- Recent history of substance abuse
- Smoking >10 cigarettes/day
- Participation in other clinical studies within 14 days of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods.
This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.
- Conditions
- Plaque, Dental, Gingivitis
- Being tested
- Tapered bristles A, Tapered bristles B, End rounded bristles
- 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.
Tapered bristles ADevice
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .
Tapered bristles BDevice
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
End rounded bristlesDevice
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
| Study group | Role | What they receive |
|---|---|---|
| Tapered bristles A | Experimental | Test toothbrush with tapered bristle Receives: Device: Tapered bristles A; Device: Tapered bristles B; Device: End rounded bristles |
| Tapered bristles B | Active comparator | Test toothbrush with tapered bristle Receives: Device: Tapered bristles A; Device: Tapered bristles B; Device: End rounded bristles |
| End rounded bristles | Active comparator | Conventionla toothbrush with end rounded bristle Receives: Device: Tapered bristles A; Device: Tapered bristles B; Device: End rounded bristles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Navy Plaque Index (Navy Pl) After One-time Brushing
Change of Navy Plaque Index (Navy Pl) after one-time brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. Post-brushing value is calculated by averaging PI values of 10 subjects after a one-time brushing for 2 minutes
Measured: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Change of Digitally Measured Interdental Plaque Area After One-time Brushing
Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after one-time brushing by image analysis.
Measured: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Secondary outcomes (2)
Change of Navy Plaque Index (Navy PI) After 7-day Brushing
Change of Navy Plaque Index (Navy Pl) after 7-day brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. 7-day value is calculated by averaging PI values of 10 subjects after 7-day brushing.
Measured: Pre-intervention at baseline and after 7- day brushing at baseline
Change of Digitally Measured Interdental Plaque Area After 7-day Brushing
Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after 7- day brushing by image analysis.
Measured: Pre-intervention at baseline and after 7-day brushing at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start30 Jun 2021
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunstar Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franklin Garcia-Godoy, DDS, PhD, Principal investigator, The University of Tennessee Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681885
- Sponsor's protocol ID
- CLP-2020-06-01-1
- Status last verified
- Jul 2024
- First submitted
- 18 Dec 2020
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Toothbrush Bristles in Plaque Reduction
- ClinicalTrials.gov ID
- NCT04681885
- Acronym / sponsor ID
- CLP-2020-06-01-1
- Conditions
- Plaque, Dental, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sunstar AmericasIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods.
This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tapered bristles A | Experimental | Device: Tapered bristles A, Device: Tapered bristles B, Device: End rounded bristlesTest toothbrush with tapered bristle |
| Tapered bristles B | Active comparator | Device: Tapered bristles A, Device: Tapered bristles B, Device: End rounded bristlesTest toothbrush with tapered bristle |
| End rounded bristles | Active comparator | Device: Tapered bristles A, Device: Tapered bristles B, Device: End rounded bristlesConventionla toothbrush with end rounded bristle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Tapered bristles ASubjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week . | Device | End rounded bristles, Tapered bristles A, Tapered bristles B |
| Tapered bristles BSubjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week. | Device | End rounded bristles, Tapered bristles A, Tapered bristles B |
| End rounded bristlesSubjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week. | Device | End rounded bristles, Tapered bristles A, Tapered bristles B |
Primary outcome
Change of Navy Plaque Index (Navy Pl) After One-time Brushing
Time frame: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Change of Navy Plaque Index (Navy Pl) after one-time brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. Post-brushing value is calculated by averaging PI values of 10 subjects after a one-time brushing for 2 minutes
Change of Digitally Measured Interdental Plaque Area After One-time Brushing
Time frame: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after one-time brushing by image analysis.
2 secondary outcomes
Change of Navy Plaque Index (Navy PI) After 7-day Brushing
Time frame: Pre-intervention at baseline and after 7- day brushing at baseline
Change of Digitally Measured Interdental Plaque Area After 7-day Brushing
Time frame: Pre-intervention at baseline and after 7-day brushing at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Franklin Garcia-Godoy, DDS, PhD principal investigator
The University of Tennessee Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tapered bristles A, Tapered bristles B and End rounded bristles in people with Plaque, Dental and Gingivitis, run by Sunstar Americas 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?
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 15 Oct 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?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of Navy Plaque Index (Navy Pl) After One-time Brushing (time frame: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline). 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 15 Oct 2024.