Plaque ControlNCT01994278
Comparison of Soft Toothbrush and Brushless Cleaner in Their Ability to Remove Plaque From Teeth
A study testing Peri Clean in people with Plaque Control, run by Peri-Swab, LLC.
Trial summary
The aim of this study is to observe whether a brushless cleaning device can be equally as effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people an alternative to bristle brush cleaning if they find they are brushing too hard. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Control
- What is being tested?
- Peri Clean
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Apr 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 yrs of age
- healthy gingiva
Who cannot join
- less than 18 yrs old
- patients with braces
- decisionally impaired
About this study
The aim of this study is to observe whether a brushless cleaning device can be equally as effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people an alternative to bristle brush cleaning if they find they are brushing too hard. The hypothesis is that it is possible to maintain healthy teeth and gingiva by using brushless methods in conjunction with flossing.
- Conditions
- Plaque Control
- Being tested
- Peri Clean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri CleanDevice
| Study group | Role | What they receive |
|---|---|---|
| Tooth brush | Experimental | Periclean is a soft rubber gentle toothbrush Receives: Device: Peri Clean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silness Gingival index
using a periodontal probe gently between the tooth and gum
Measured: June 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque ControlStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peri-Swab, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994278
- Sponsor's protocol ID
- 12-038A
- Status last verified
- Apr 2013
- First submitted
- 31 Jul 2012
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Soft Toothbrush and Brushless Cleaner in Their Ability to Remove Plaque From Teeth
- ClinicalTrials.gov ID
- NCT01994278
- Acronym / sponsor ID
- 12-038A
- Conditions
- Plaque Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Peri-Swab, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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 aim of this study is to observe whether a brushless cleaning device can be equally as effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people an alternative to bristle brush cleaning if they find they are brushing too hard. The hypothesis is that it is possible to maintain healthy teeth and gingiva by using brushless methods in conjunction with flossing.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tooth brush | Experimental | Device: Peri CleanPericlean is a soft rubber gentle toothbrush |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 yrs of age
- healthy gingiva
Key exclusion criteria (3 listed)
- less than 18 yrs old
- patients with braces
- decisionally impaired
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 |
|---|---|---|
| Peri Clean | Device | Tooth brush |
Primary outcome
Silness Gingival index
Time frame: June 2013
using a periodontal probe gently between the tooth and gum
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 25 Nov 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Peri Clean in people with Plaque Control, run by Peri-Swab, LLC.
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 2 inclusion and 3 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Silness Gingival index (time frame: June 2013). 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 25 Nov 2013.