Dental PlaqueNCT01250769
Evaluating the Effect of Tooth Cleaning Devices on Oral Health
A study testing Manual Toothbrush and Interproximal Cleaning Device in people with Dental Plaque, run by Philips Oral Healthcare at 1 site in United States.
Trial summary
This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Manual Toothbrush and Interproximal Cleaning Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are in good/excellent health;
- are 18 - 70 years old;
- have a minimum of 20 natural teeth (excluding 3rd molars);
- have sufficient test sites;
- have ≥ 20 bleeding sites;
- are willing to participate and available for participation.
Who cannot join
- have systemic diseases such as Down's syndrome, or known AIDS/HIV;
- have insulin dependant Diabetes;
- are pregnant or nursing by subject report;
- have a cardiac pacemaker
- are undergoing or require extensive dental or orthodontic treatment;
- require antibiotic treatment for dental appointments;
Show all 14Show fewer
- have heavy deposits of calculus;
- have severe gingivitis or periodontitis;
- have extensive crown or bridge work and/or rampant decay;
- currently use bleaching trays;
- have any oral or extraoral piercing on lips or in mouth;
- have a professional prophylaxis within 4 weeks of study;
- participation in a prior study ≤ 20 days;
- employed by a oral healthcare products company or research institution.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Park Research Center
Fort Wayne, Indiana, 46825
About this study
Official title: Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health
This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.
- Conditions
- Dental Plaque
- Being tested
- Manual Toothbrush, Interproximal Cleaning Device
- Keywords
- dental, dentist, plaque, IP Cleaning
- Medical subject headings
- Dental Plaque, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ToothbrushDevice
Also called ADA Reference Toothbrush
A standard size manual toothbrush to clean visible tooth surfaces
Interproximal Cleaning DeviceDevice
Also called Philips AirFloss
An electronic device that combines water and air to clean between the teeth
| Study group | Role | What they receive |
|---|---|---|
| Manual Toothbrush 1 | Active comparator | Manual Toothbrush used for 1 minute twice a day Receives: Device: Manual Toothbrush |
| Manual Toothbrush 2 | Active comparator | Manual Toothbrush used for 2 minutes twice a day Receives: Device: Manual Toothbrush |
| Manual Toothbrush + Interproximal Cleaning 1 | Experimental | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day Receives: Device: Manual Toothbrush; Device: Interproximal Cleaning Device |
| Manual Toothbrush + Interproximal Cleaning 2 | Experimental | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day Receives: Device: Manual Toothbrush; Device: Interproximal Cleaning Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Protein Concentration
Residual protein concentration of interproximal plaque samples
Measured: 14 days
Secondary outcomes (5)
Residual Protein Concentration
Residual protein concentration of interproximal plaque samples
Measured: 28 days
Modified Gingival Index
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Measured: 14 days
Modified Gingival Index
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Measured: 28 days
Gingival Bleeding Index
Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)
Measured: 14 days
Gingival Bleeding Index
Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
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 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Oral Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wendy Jenkins, Study director, POHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250769
- Sponsor's protocol ID
- DRC-0703
- Status last verified
- Aug 2012
- First submitted
- 5 May 2010
- Last updated
- 19 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health
- ClinicalTrials.gov ID
- NCT01250769
- Acronym / sponsor ID
- DRC-0703
- Conditions
- Dental Plaque
- Keywords
- dental, dentist, plaque, IP Cleaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Philips Oral HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Posted 19 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Manual Toothbrush 1 | Active comparator | Device: Manual ToothbrushManual Toothbrush used for 1 minute twice a day |
| Manual Toothbrush 2 | Active comparator | Device: Manual ToothbrushManual Toothbrush used for 2 minutes twice a day |
| Manual Toothbrush + Interproximal Cleaning 1 | Experimental | Device: Manual Toothbrush, Device: Interproximal Cleaning DeviceManual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day |
| Manual Toothbrush + Interproximal Cleaning 2 | Experimental | Device: Manual Toothbrush, Device: Interproximal Cleaning DeviceManual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- are in good/excellent health;
- are 18 - 70 years old;
- have a minimum of 20 natural teeth (excluding 3rd molars);
- have sufficient test sites;
- have ≥ 20 bleeding sites;
Key exclusion criteria (14 listed)
- have systemic diseases such as Down's syndrome, or known AIDS/HIV;
- have insulin dependant Diabetes;
- are pregnant or nursing by subject report;
- have a cardiac pacemaker
- are undergoing or require extensive dental or orthodontic treatment;
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 |
|---|---|---|
| Manual ToothbrushAlso: ADA Reference ToothbrushA standard size manual toothbrush to clean visible tooth surfaces | Device | Manual Toothbrush + Interproximal Cleaning 1, Manual Toothbrush + Interproximal Cleaning 2, Manual Toothbrush 1, Manual Toothbrush 2 |
| Interproximal Cleaning DeviceAlso: Philips AirFlossAn electronic device that combines water and air to clean between the teeth | Device | Manual Toothbrush + Interproximal Cleaning 1, Manual Toothbrush + Interproximal Cleaning 2 |
Primary outcome
Residual Protein Concentration
Time frame: 14 days
Residual protein concentration of interproximal plaque samples
5 secondary outcomes
Residual Protein Concentration
Time frame: 28 days
Modified Gingival Index
Time frame: 14 days
Modified Gingival Index
Time frame: 28 days
Gingival Bleeding Index
Time frame: 14 days
Gingival Bleeding Index
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
- 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.
Wendy Jenkins study director
POHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Toothbrush and Interproximal Cleaning Device in people with Dental Plaque, run by Philips Oral Healthcare 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 6 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 19 Sep 2012. 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 19 Sep 2012). 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?
Residual Protein Concentration (time frame: 14 days). 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 19 Sep 2012.