GingivitisNCT01700348
Philips AirFlosser Study
A study testing Airflosser and Manual Floss in people with Gingivitis, run by Tufts University at 1 site in United States.
Trial summary
In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and who exhibit signs of moderate gingivitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Airflosser and Manual Floss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2013
- 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
4.1 Inclusion Criteria
Subjects accepted into the study must meet the following requirements:
- are 18-70 years;
- are in generally good health;
- have a minimum of 20 natural teeth (excluding 3rd molars);
- have 1 qualifying test site in each posterior quadrant;
- are a regular manual toothbrush user (prior periodic use of powered toothbrushes in other studies permitted);
- Irregular Flossers defined as using dental floss ≤ 2 days a week;
- be willing and able to comply with study procedures and be available at all times required for participation;
- have a Gingival Bleeding Index > 1 on at least 20 sites;
- be a non-smoker.
4.2 Exclusion Criteria Subjects will be excluded from the study if they;
- have systemic diseases such as Down's syndrome, or known AIDS/HIV;
- have insulin dependent Diabetes;
- are pregnant or nursing by subject report;
- have a cardiac pacemaker or AICD;
- are undergoing or require extensive dental or orthodontic treatment;
- require antibiotic treatment for dental appointments;
- have used antibiotics within 4 weeks of enrollment;
- are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin);
- have heavy deposits of calculus, either supragingival and/or subgingival;
- have severe gingivitis or periodontitis;
- have extensive crown or bridge work and/or rampant decay;
- are currently use bleaching trays;
- have any oral or extraoral piercing on lips or in mouth with ornament or accessory;
- have a professional prophylaxis within 4 weeks of study;
- have participated in a prior study ≤ 20 days;
- are employed by an oral healthcare products company or dental research institution.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque
In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No Intervention group and will be given no test products or instruction other than to change none of their typical at home oral hygiene habits.
The aim of this study is to investigate how an AF and MTB oral hygiene intervention will affect a population of irregular flossers using the residual protein concentration method as an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices
- Conditions
- Gingivitis
- Being tested
- Airflosser, Manual Floss
- Keywords
- moderate gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirflosserDevice
Also called Philips Airflosser
Use of Philips Airflosser
Manual FlossDevice
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Airflosser | Experimental | Use of Airflosser Receives: Device: Airflosser |
| Manual Floss | Active comparator | Normal Routine Receives: Device: Manual Floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group
The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.
Measured: Four Months
Secondary outcomes (5)
Gingival Inflammation
Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.
Measured: 4 weeks
Number of Bleeding Sites
Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.
Measured: 2 Weeks
Plaque
Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.
Measured: 4 Weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Assess the safety of the Sonicare AirFloss + MTB treatment.
Measured: 4 Months
Percentage of Bleeding Sites
Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Terminated by financier due to low accrual \& high number of protocol deviations.
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 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
- Investigator
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Oral Healthcare
- Responsible party
- Sponsor
- Investigators
- Gerard Kugel, DMD, MS, PhD, Principal investigator, TUSDM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700348
- Sponsor's protocol ID
- MAH-12-0081
- Other IDs
- 10438
- Status last verified
- Jul 2019
- First submitted
- 20 Aug 2012
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque
- ClinicalTrials.gov ID
- NCT01700348
- Acronym / sponsor ID
- MAH-12-0081
- Conditions
- Gingivitis
- Keywords
- moderate gingivitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by financier due to low accrual \& high number of protocol deviations.
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Philips Oral Healthcare
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Posted 29 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No Intervention group and will be given no test products or instruction other than to change none of their typical at home oral hygiene habits.
The aim of this study is to investigate how an AF and MTB oral hygiene intervention will affect a population of irregular flossers using the residual protein concentration method as an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airflosser | Experimental | Device: AirflosserUse of Airflosser |
| Manual Floss | Active comparator | Device: Manual FlossNormal Routine |
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 |
|---|---|---|
| AirflosserAlso: Philips AirflosserUse of Philips Airflosser | Device | Airflosser |
| Manual FlossActive Comparator | Device | Manual Floss |
Primary outcome
The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group
Time frame: Four Months
The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.
5 secondary outcomes
Gingival Inflammation
Time frame: 4 weeks
Number of Bleeding Sites
Time frame: 2 Weeks
Plaque
Time frame: 4 Weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 4 Months
Percentage of Bleeding Sites
Time frame: 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Gingivitis
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The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
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Alpha-Lipoic Acid as an Adjunct to Non-Surgical Periodontal Treatment in Gingivitis
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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.
Gerard Kugel, DMD, MS, PhD principal investigator
TUSDM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airflosser and Manual Floss in people with Gingivitis, run by Tufts University 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: stopped early, as of the sponsor's last update on 6 Aug 2019. 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 29 May 2015). 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?
The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group (time frame: Four Months). 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 6 Aug 2019; AzTrials last refreshed its copy on 27 Oct 2026.