GingivitisPhase 4NCT07211061
A Study is to Evaluate a Regimen on Gingivitis Using Traditional and Novel Assessment Methods
A Phase 4 study testing Stannous Fluoride Dentifrice, Sodium Fluoride Dentifrice and electric toothbrush in people with Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to brush 2x a day in using a power brush (2 minutes of brushing), followed by using 20 ml of mouth rinse for 30 seconds for… 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?
- Stannous Fluoride Dentifrice, Sodium Fluoride Dentifrice and electric toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2011to 10 Nov 2011
- Phase
- Phase 4
- 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
- Provide written informed consent to participate in the study;
- Be 18 years of age or older;
- Agree not to participate in any other oral/dental product studies during the course of this study;
- Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
- Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
- Have a Baseline MGI score of at least 1.75 but not greater than 2.3;
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- Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
- Agree to return for all scheduled visits and follow study procedures;
- Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.
Who cannot join
- Have had a dental prophylaxis within 2 weeks of Baseline visit;
- Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
- Have rampant caries, open or untreated caries, severe gingivitis, or advanced periodontitis requiring prompt treatment; or,
- Need an antibiotic prophylaxis prior to dental visits,
- Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study,
- Are pregnant (Self-reported) or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bio-Sci Research (Out of Business)
Las Vegas, Nevada, 89121
About this study
Official title: A SIX WEEK CLINICAL STUDY TO EVALUATE THE EFFECT OF A REGIMEN ON GINGIVITIS
Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to brush 2x a day in using a power brush (2 minutes of brushing), followed by using 20 ml of mouth rinse for 30 seconds for 6 weeks. The negative control group will be asked to brush 2x a day using a manual toothbrush in their customary manner for 6 weeks. Oral Soft Tissue (OST) assessments, gingivitis and plaque measurements will be taken at 4 time-points: Baseline (BL); Week 1; Week 3; and Week 6.
- Conditions
- Gingivitis
- Being tested
- Stannous Fluoride Dentifrice, Sodium Fluoride Dentifrice, electric toothbrush, Cetylpyridinium Chloride (CPC), manual toothbrush
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous Fluoride DentifriceDrug
brush 2x a day in using a power brush (2 minutes of brushing)
Sodium Fluoride DentifriceDrug
brush in their customary manner
electric toothbrushDevice
brush using a electric brush (2 minutes of brushing)
Cetylpyridinium Chloride (CPC)Drug
use 20 ml of mouth rinse for 30 seconds
manual toothbrushDevice
brush in their customary manner
| Study group | Role | What they receive |
|---|---|---|
| Oral Hygiene Regimen | Experimental | toothpaste, electric toothbrush, and mouth rinse Receives: Drug: Stannous Fluoride Dentifrice; Device: electric toothbrush; Drug: Cetylpyridinium Chloride (CPC) |
| Negative Control | Active comparator | toothpaste and manual toothbrush Receives: Drug: Sodium Fluoride Dentifrice; Device: manual toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding (GBI)
Gingival Bleeding Index- evaluation of bleeding from gingival tissue, score from 0-2
Measured: Week 1, Week 3, and Week 6
Secondary outcomes (1)
Inflammation (MGI)
Modified Gingival Index- evaluation of the level of gingival tissue inflammation, scores from 0-4
Measured: Week 1, Week 3, and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start21 Sep 2011
- Primary completion10 Nov 2011
- Study completion10 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211061
- Sponsor's protocol ID
- 2011068
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SIX WEEK CLINICAL STUDY TO EVALUATE THE EFFECT OF A REGIMEN ON GINGIVITIS
- ClinicalTrials.gov ID
- NCT07211061
- Acronym / sponsor ID
- 2011068
- Conditions
- Gingivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2011 (actual)
- Primary completion
- 10 Nov 2011 (actual)
- Study completion
- 10 Nov 2011 (actual)
- First posted
- 7 Oct 2025 (actual)
- 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.
Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to brush 2x a day in using a power brush (2 minutes of brushing), followed by using 20 ml of mouth rinse for 30 seconds for 6 weeks. The negative control group will be asked to brush 2x a day using a manual toothbrush in their customary manner for 6 weeks. Oral Soft Tissue (OST) assessments, gingivitis and plaque measurements will be taken at 4 time-points: Baseline (BL); Week 1; Week 3; and Week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Hygiene Regimen | Experimental | Drug: Stannous Fluoride Dentifrice, Device: electric toothbrush, Drug: Cetylpyridinium Chloride (CPC)toothpaste, electric toothbrush, and mouth rinse |
| Negative Control | Active comparator | Drug: Sodium Fluoride Dentifrice, Device: manual toothbrushtoothpaste and manual toothbrush |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide written informed consent to participate in the study;
- Be 18 years of age or older;
- Agree not to participate in any other oral/dental product studies during the course of this study;
- Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
- Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
Key exclusion criteria (6 listed)
- Have had a dental prophylaxis within 2 weeks of Baseline visit;
- Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
- Have rampant caries, open or untreated caries, severe gingivitis, or advanced periodontitis requiring prompt treatment; or,
- Need an antibiotic prophylaxis prior to dental visits,
- Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of 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 |
|---|---|---|
| Stannous Fluoride Dentifricebrush 2x a day in using a power brush (2 minutes of brushing) | Drug | Oral Hygiene Regimen |
| Sodium Fluoride Dentifricebrush in their customary manner | Drug | Negative Control |
| electric toothbrushbrush using a electric brush (2 minutes of brushing) | Device | Oral Hygiene Regimen |
| Cetylpyridinium Chloride (CPC)use 20 ml of mouth rinse for 30 seconds | Drug | Oral Hygiene Regimen |
| manual toothbrushbrush in their customary manner | Device | Negative Control |
Primary outcome
Bleeding (GBI)
Time frame: Week 1, Week 3, and Week 6
Gingival Bleeding Index- evaluation of bleeding from gingival tissue, score from 0-2
1 secondary outcome
Inflammation (MGI)
Time frame: Week 1, Week 3, and Week 6
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 7 Oct 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stannous Fluoride Dentifrice, Sodium Fluoride Dentifrice and electric toothbrush in people with Gingivitis, run by Procter and Gamble 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 9 inclusion and 6 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 7 Oct 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bleeding (GBI) (time frame: Week 1, Week 3, and Week 6). 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 7 Oct 2025.