GingivitisPhase 3NCT00964860
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
A Phase 3 study testing Glide dental floss in people with Gingivitis, run by Procter and Gamble at 1 site in Guatemala.
Trial summary
This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing gingivitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Glide dental floss
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGuatemala
- Study dates
- Aug 2009to Aug 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be included in the study, each subject must:
- be at least 18 years of age;
- be physically able to floss their teeth;
- have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);
- have refrained from performing oral hygiene the morning of the Baseline visit;
- be in good general health;
- have interproximal MGI (Modified Gingival Index) score of >2.8.
Who cannot join
- Subjects are excluded from study participation where there is evidence of:
- severe periodontal disease;
- discoloration or pigmentation in the gingival tissue;
- meaningful misalignment of front teeth;
- fixed facial orthodontic appliances;
- use of antibiotics within two weeks of the Baseline Visit and at any time during the study;
- any diseases or conditions that could be expected to interfere with the subject safely completing the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing gingivitis.
- Conditions
- Gingivitis
- Being tested
- Glide dental floss
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glide dental flossDevice
Glide waxed dental floss
| Study group | Role | What they receive |
|---|---|---|
| Brushing Only | No intervention | Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice |
| Brushing + Flossing | Experimental | Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss Receives: Device: Glide dental floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation
Measured: 30 days
Secondary outcomes (1)
Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
Whole-mouth average MGI scores were calculated separately for each subject and visit by averaging the MGI scores of all gradable sites. Interpoximal average MGI scores were also calculated for each subject and visit by averaging over only interpoximal sites (buccal-mesial, buccal-distal, lingual-mesian, and lingual-distal).
Within each treatment, changes from baseline were analyzed using paired t-test. Between treatments mean comparisons were conducted using analysis of covariance with baseline MGI score as a covariate. All statistical comparisons were two-sided with a 5% significance level.
The average MGI score for a subject can range from 0 (no gingivitis) to 4 (inflammation on all gradable sites).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2009
- Study completionAug 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Witt, PhD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964860
- Sponsor's protocol ID
- 2009061
- Status last verified
- Oct 2012
- First submitted
- 20 Aug 2009
- Last updated
- 31 Oct 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 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
- ClinicalTrials.gov ID
- NCT00964860
- Acronym / sponsor ID
- 2009061
- Conditions
- Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Posted 31 Oct 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 randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing gingivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brushing Only | No intervention | –Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice |
| Brushing + Flossing | Experimental | Device: Glide dental flossBrushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be at least 18 years of age;
- be physically able to floss their teeth;
- have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);
- have refrained from performing oral hygiene the morning of the Baseline visit;
- be in good general health;
Key exclusion criteria (7 listed)
- severe periodontal disease;
- discoloration or pigmentation in the gingival tissue;
- meaningful misalignment of front teeth;
- fixed facial orthodontic appliances;
- use of antibiotics within two weeks of the Baseline Visit and at any time during 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 |
|---|---|---|
| Glide dental flossGlide waxed dental floss | Device | Brushing + Flossing |
Primary outcome
Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
Time frame: 30 days
Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation
1 secondary outcome
Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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.
Jon Witt, PhD study director
Procter and Gamble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glide dental floss in people with Gingivitis, run by Procter and Gamble at 1 site in Guatemala.
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 7 inclusion and 7 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 31 Oct 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 Guatemala. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 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?
Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group (time frame: 30 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 31 Oct 2012.