Gingival DiseasesNCT06659471
Brief Title: a Clinical Study to Assess Gingivitis
A study testing 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice in people with Gingival Diseases, run by Procter and Gamble at 1 site in United States.
Trial summary
The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 6 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age;
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
- Have at least 20 gradable teeth;
- Have established gingivitis with 10-70 % bleeding sites;
- Agree to return for scheduled visits and follow the study procedures;
- Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
- Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.
Who cannot join
- Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
- Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
- Having known hypersensitivity to the test products;
- Having removable oral appliances;
- Having fixed facial or lingual orthodontic appliances;
- Self-reported pregnancy or lactation;
- Having any diseases or condition that might interfere with the safe participation in the study;
- Having an inability to undergo study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Month Bleeding Model Clinical Study
The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.
- Conditions
- Gingival Diseases
- Being tested
- 0.76% Sodium Monofluorophosphate Dentifrice, 0.454% Stannous Fluoride Dentifrice
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.76% Sodium Monofluorophosphate DentifriceDrug
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
0.454% Stannous Fluoride DentifriceDrug
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| 0.76% Sodium Monofluorophosphate | Sham comparator | 0.76% Sodium Monofluorophosphate Receives: Drug: 0.76% Sodium Monofluorophosphate Dentifrice |
| 0.454% Stannous Fluoride | Active comparator | 0.454% Stannous Fluoride Receives: Drug: 0.454% Stannous Fluoride Dentifrice |
| 0.454% Stannous Fluoride, 4.7 pH | Experimental | 0.454% Stannous Fluoride, 4.7 pH Receives: Drug: 0.454% Stannous Fluoride Dentifrice |
| 0.454% Stannous Fluoride, 5.8 pH | Experimental | 0.454% Stannous Fluoride, 5.8 pH Receives: Drug: 0.454% Stannous Fluoride Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Bleeding Sites
Number of bleeding sites derived from the Löe-Silness Gingivitis Evaluation based on a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Measured: 3 months, 1 month
Secondary outcomes (1)
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Measured: 3 months, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start7 Mar 2022
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival DiseasesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 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
- NCT06659471
- Sponsor's protocol ID
- 2021117
- Status last verified
- Mar 2022
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Month Bleeding Model Clinical Study
- ClinicalTrials.gov ID
- NCT06659471
- Acronym / sponsor ID
- 2021117
- Conditions
- Gingival Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 26 Oct 2024 (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.
The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.76% Sodium Monofluorophosphate | Sham comparator | Drug: 0.76% Sodium Monofluorophosphate Dentifrice0.76% Sodium Monofluorophosphate |
| 0.454% Stannous Fluoride | Active comparator | Drug: 0.454% Stannous Fluoride Dentifrice0.454% Stannous Fluoride |
| 0.454% Stannous Fluoride, 4.7 pH | Experimental | Drug: 0.454% Stannous Fluoride Dentifrice0.454% Stannous Fluoride, 4.7 pH |
| 0.454% Stannous Fluoride, 5.8 pH | Experimental | Drug: 0.454% Stannous Fluoride Dentifrice0.454% Stannous Fluoride, 5.8 pH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be at least 18 years of age;
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
- Have at least 20 gradable teeth;
- Have established gingivitis with 10-70 % bleeding sites;
Key exclusion criteria (8 listed)
- Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
- Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
- Having known hypersensitivity to the test products;
- Having removable oral appliances;
- Having fixed facial or lingual orthodontic appliances;
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 |
|---|---|---|
| 0.76% Sodium Monofluorophosphate DentifriceWhole mouth brushing with a toothpaste, twice daily for the duration of the study. | Drug | 0.76% Sodium Monofluorophosphate |
| 0.454% Stannous Fluoride DentifriceWhole mouth brushing with a toothpaste, twice daily for the duration of the study. | Drug | 0.454% Stannous Fluoride, 0.454% Stannous Fluoride, 4.7 pH, 0.454% Stannous Fluoride, 5.8 pH |
Primary outcome
Number Bleeding Sites
Time frame: 3 months, 1 month
Number of bleeding sites derived from the Löe-Silness Gingivitis Evaluation based on a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
1 secondary outcome
Löe-Silness Gingivitis Evaluation
Time frame: 3 months, 1 month
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 26 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Gingival Diseases
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Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
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Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
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Gingivitis
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 study testing 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice in people with Gingival Diseases, 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 8 inclusion and 8 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 26 Oct 2024. 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. Some participants in this study may receive a placebo. 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?
Number Bleeding Sites (time frame: 3 months, 1 month). 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 26 Oct 2024.