Subgingival PlaqueNCT03296657
Analysis of Stannous Fluoride in GCF and Subgingival Plaque
A study testing stannous fluoride in people with Subgingival Plaque and GCF, run by Procter and Gamble at 1 site in United States.
Trial summary
The amount of stannous fluoride in GCF and subgingival plaque samples will be analyzed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subgingival Plaque, GCF
- What is being tested?
- stannous fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to 22 Sep 2017
- 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
- 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 use the acclimation products and to refrain from using any other oral care products (including floss and mouth rinse) between the Acclimation and Baseline Visit;
- Agree to use the treatment products and refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss, mouth rinse, or whitening products;
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- Agree to return for all scheduled visits and follow study procedures;
- Must 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;
- Agree to refrain from all oral hygiene after 11 p.m. the night prior to each visit;
- Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
- Have minimum 20 sampling sites with bleeding and pocket depth ≥2mm but not deeper than 4mm.
Who cannot join
- Having a dental prophylaxis within 2 weeks of Acclimation visit;
- Having rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
- A medical condition requiring an antibiotic prophylaxis prior to dental visits;
- A history of hypersensitivity to oral care products containing stannous fluoride; or
- Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history, 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 Stannous Fluoride in GCF and Subgingival Plaque
The amount of stannous fluoride in GCF and subgingival plaque samples will be analyzed.
Read the detailed description
This is pilot study involving approximately 20 subjects with at least 20 dental pockets between 2- 4mm with bleeding for sampling. Subjects will have up to 10 sites identified as "sampling sites" that will have supragingival plaque, subgingival plaque, and gingival crevicular fluid (GCF) collected at Baseline, 30 minutes, 24 hours, and Week 2.
- Conditions
- Subgingival Plaque, GCF
- Being tested
- stannous fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stannous fluorideDrug
subjects will brush with paste twice daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| stannous fluoride toothpaste | Experimental | 0.454% stannous fluoride will be used twice a day, brushing for at least 1 minute for 2 weeks Receives: Drug: stannous fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of tin in GCF sample
per GCF sample amount of stannous level in ng/uL will be measured
Measured: mean difference from 30 minutes to baseline
Secondary outcomes (1)
Amount of tin in GCF and Subgingival Plaque
stannous level in subgingival plaque will be measured as concentration in ng, per GCF sample amount of stannous level in ng/uL
Measured: change from visit (change from 24 hours to baseline, change Week 2 to baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start23 Aug 2017
- Primary completion22 Sep 2017
- Study completion22 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subgingival PlaqueStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- subject will brush twice a day for 2 weeks with stannous fluoride paste for at least 1 minute
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Milleman, Principal investigator, Salus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296657
- Sponsor's protocol ID
- CSD2017123
- Status last verified
- Nov 2017
- First submitted
- 13 Sep 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Stannous Fluoride in GCF and Subgingival Plaque
- ClinicalTrials.gov ID
- NCT03296657
- Acronym / sponsor ID
- CSD2017123
- Conditions
- Subgingival Plaque, GCF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 22 Sep 2017 (actual)
- Study completion
- 22 Sep 2017 (actual)
- First posted
- 28 Sep 2017 (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 amount of stannous fluoride in GCF and subgingival plaque samples will be analyzed.
Detailed description
This is pilot study involving approximately 20 subjects with at least 20 dental pockets between 2- 4mm with bleeding for sampling. Subjects will have up to 10 sites identified as "sampling sites" that will have supragingival plaque, subgingival plaque, and gingival crevicular fluid (GCF) collected at Baseline, 30 minutes, 24 hours, and Week 2.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- subject will brush twice a day for 2 weeks with stannous fluoride paste for at least 1 minute
| Arm | Type | Receives |
|---|---|---|
| stannous fluoride toothpaste | Experimental | Drug: stannous fluoride0.454% stannous fluoride will be used twice a day, brushing for at least 1 minute for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 use the acclimation products and to refrain from using any other oral care products (including floss and mouth rinse) between the Acclimation and Baseline Visit;
Key exclusion criteria (5 listed)
- Having a dental prophylaxis within 2 weeks of Acclimation visit;
- Having rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
- A medical condition requiring an antibiotic prophylaxis prior to dental visits;
- A history of hypersensitivity to oral care products containing stannous fluoride; or
- Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history, which could be expected to interfere with examination procedures or with 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 fluoridesubjects will brush with paste twice daily for 2 weeks | Drug | stannous fluoride toothpaste |
Primary outcome
Amount of tin in GCF sample
Time frame: mean difference from 30 minutes to baseline
per GCF sample amount of stannous level in ng/uL will be measured
1 secondary outcome
Amount of tin in GCF and Subgingival Plaque
Time frame: change from visit (change from 24 hours to baseline, change Week 2 to baseline)
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 6 Nov 2017.
Related trials for Subgingival Plaque
RecruitingObservational study
PERIodontal Disease, Microbiota and Miscarriage
Miscarriage, Parodontitis
Recruiting
Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons
Dental Plaque, Bleeding of Subgingival Space
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.
Jeff Milleman principal investigator
Salus Research
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 Subgingival Plaque and GCF, 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 12 inclusion and 5 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 6 Nov 2017. 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?
Amount of tin in GCF sample (time frame: mean difference from 30 minutes to baseline). 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 Nov 2017.