GingivitisNCT05326373
Stannous Fluoride and Gingivitis
A study testing Stannous fluoride in people with Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 13 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older;
- Provide written informed consent and receive a signed copy of consent;
- Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study;
- Agree not to participate in any other oral care studies for the duration of this study;
- 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;
- Agree to return for all scheduled visits and follow study procedures;
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- Have at least 16 natural teeth;
- 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.
- For Unhealthy Group:
- Have at least 20 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
- Have a minimum of 3 sampling sites with bleeding and pocket depth >/=3mm but not deeper than 4mm at the Screening visit.
- For Healthy Group:
- Have a maximum of 3 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
- No pockets deeper than 2mm.
Who cannot join
- Self-reported pregnancy or the intent to become pregnant anytime during the course of the study;
- Inability to comply with study procedures;
- Rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
- Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
- Fixed orthodontic appliances or attachments for aligner treatment;
- Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
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- Having taken antibiotics or used anti-gingivitis/anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
- Needing an antibiotic prophylaxis prior to dental visits;
- Presenting with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or
- Having any condition or disease, as determined by the Investigator/Designee which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods
8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint.
- Conditions
- Gingivitis
- Being tested
- Stannous fluoride
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous fluorideDrug
brush twice daily with stannous fluoride toothpaste for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Healthy Group | Active comparator | Subjects without gingivitis (</= 3 bleeding sites) will use stannous fluoride toothpaste Receives: Drug: Stannous fluoride |
| Unhealthy Group | Active comparator | Subjects with gingivitis (>/= bleeding 20 sites) will use stannous fluoride toothpaste Receives: Drug: Stannous fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
MGI
Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation).
Measured: 8 weeks
GBI
Gingival Bleeding Index- validated assessment of gingival health looking at bleeding based on 2-point range 0 (Absence of bleeding) to 2 (Immediate bleeding)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start11 Apr 2022
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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
- NCT05326373
- Sponsor's protocol ID
- 2022001
- Status last verified
- Jun 2022
- First submitted
- 6 Apr 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramji N, Xie S, Bunger A, Trenner R, Ye H, Farmer T, Reichling T, Ashe J, Milleman K, Milleman J, Klukowska M. Effects of stannous fluoride dentifrice on gingival health and oxidative stress markers: a prospective clinical trial. BMC Oral Health. 2024 Aug 30;24(1):1019. doi: 10.1186/s12903-024-04785-7.
PubMed 39215289
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods
- ClinicalTrials.gov ID
- NCT05326373
- Acronym / sponsor ID
- 2022001
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 13 Apr 2022 (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.
8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Group | Active comparator | Drug: Stannous fluorideSubjects without gingivitis (</= 3 bleeding sites) will use stannous fluoride toothpaste |
| Unhealthy Group | Active comparator | Drug: Stannous fluorideSubjects with gingivitis (>/= bleeding 20 sites) will use stannous fluoride toothpaste |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be 18 years of age or older;
- Provide written informed consent and receive a signed copy of consent;
- Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study;
- Agree not to participate in any other oral care studies for the duration of this study;
- 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 (10 listed)
- Self-reported pregnancy or the intent to become pregnant anytime during the course of the study;
- Inability to comply with study procedures;
- Rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
- Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
- Fixed orthodontic appliances or attachments for aligner 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 |
|---|---|---|
| Stannous fluoridebrush twice daily with stannous fluoride toothpaste for 8 weeks | Drug | Healthy Group, Unhealthy Group |
Primary outcome
MGI
Time frame: 8 weeks
Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation).
GBI
Time frame: 8 weeks
Gingival Bleeding Index- validated assessment of gingival health looking at bleeding based on 2-point range 0 (Absence of bleeding) to 2 (Immediate bleeding)
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 16 Jun 2022.
- Derived from this study: PubMed 39215289Ramji N, Xie S, Bunger A, Trenner R, Ye H, Farmer T, Reichling T, Ashe J, Milleman K, Milleman J, Klukowska M. Effects of stannous fluoride dentifrice on gingival health and oxidative stress markers: a prospective clinical trial. BMC Oral Health. 2024 Aug 30;24(1):1019. doi: 10.1186/s12903-024-04785-7.
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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 study testing Stannous fluoride 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 14 inclusion and 10 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 16 Jun 2022. 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?
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?
MGI (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326373, which also lists 1 linked publication.
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 16 Jun 2022.