Subgingival PlaqueNCT02841839
A Study to Evaluate Sampling Methods for Subgingival Plaque
A study testing Stannous Fluoride in people with Subgingival Plaque, run by Procter and Gamble.
Trial summary
To identify a sampling method for collecting subgingival plaque 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
- What is being tested?
- Stannous Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2016
- 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 toothpaste together with their regular brush and refrain from any other oral care products (including floss and mouth rinse) between the Screening 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 for at least 12 hours prior to each visit;
- Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
- Have 10-20 bleeding sites; and
- Have minimum 6 sampling sites with bleeding and pocket depth ≥2mm but not deeper than 4mm.
Who cannot join
- Have had a dental prophylaxis within 2 weeks of plaque sampling visits;
- 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, or advanced periodontitis requiring prompt treatment;
- Taking allergy medication or any other medication that can affect salivary flow such as an antihistamine;
- Need an antibiotic prophylaxis prior to dental visits;
- A history of hypersensitivity to oral care products containing hydrogen peroxide or stannous fluoride;
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- A history of hypersensitivity to products containing sodium lauryl sulfate (SLS);
- Are pregnant (Self-reported) or lactating; 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.
About this study
Official title: A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque
To identify a sampling method for collecting subgingival plaque
- Conditions
- Subgingival Plaque
- 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
| Study group | Role | What they receive |
|---|---|---|
| 2-step system | Experimental | Subjects are to brush with 2-step system for 4 weeks; stannous fluoride Receives: Drug: Stannous Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subgingival plaque
subgingival plaque quantity measured by periopaper or curette sampling
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841839
- Sponsor's protocol ID
- 2016135
- Status last verified
- Nov 2023
- First submitted
- 11 Jul 2016
- Last updated
- 15 Nov 2023
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque
- ClinicalTrials.gov ID
- NCT02841839
- Acronym / sponsor ID
- 2016135
- Conditions
- Subgingival Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Jul 2016 (estimated)
- 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.
To identify a sampling method for collecting subgingival plaque
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2-step system | Experimental | Drug: Stannous FluorideSubjects are to brush with 2-step system for 4 weeks; stannous fluoride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 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 toothpaste together with their regular brush and refrain from any other oral care products (including floss and mouth rinse) between the Screening and Baseline Visit;
Key exclusion criteria (9 listed)
- Have had a dental prophylaxis within 2 weeks of plaque sampling visits;
- 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, or advanced periodontitis requiring prompt treatment;
- Taking allergy medication or any other medication that can affect salivary flow such as an antihistamine;
- Need an antibiotic prophylaxis prior to dental visits;
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 | Drug | 2-step system |
Primary outcome
Subgingival plaque
Time frame: 4 weeks
subgingival plaque quantity measured by periopaper or curette sampling
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 15 Nov 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Stannous Fluoride in people with Subgingival Plaque, run by Procter and Gamble.
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 13 inclusion and 9 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Subgingival plaque (time frame: 4 weeks). 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 15 Nov 2023.