PlaqueNCT02574221
A Pilot Study to Evaluate a Molecular Method for Plaque
A study testing stannous fluoride toothpaste and cavity protection toothpaste in people with Plaque and Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
This study is to evaluate the sensitivity of the molecular method and its ability to split a stannous fluoride toothpaste versus a negative control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque, Gingivitis
- What is being tested?
- stannous fluoride toothpaste and cavity protection toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Oct 2015
- 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
- In order to be included in the study, each subject must:
- 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 maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time;
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- Agree to 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 or whitening products;
- 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 at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
- Have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm;
- Have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm.
Who cannot join
- Subjects are excluded from study participation where there is evidence of:
- 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;
- Need an antibiotic prophylaxis prior to dental visits;
- A history of hypersensitivity to oral care products containing stannous fluoride;
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- A history of hypersensitivity to dyes (from products containing food dyes);
- 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; or
- Are pregnant (Self-reported) or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity
This study is to evaluate the sensitivity of the molecular method and its ability to split a stannous fluoride toothpaste versus a negative control.
- Conditions
- Plaque, Gingivitis
- Being tested
- stannous fluoride toothpaste, cavity protection toothpaste
- Medical subject headings
- Plaque, Amyloid, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stannous fluoride toothpasteDrug
0.454% stannous fluoride toothpaste
cavity protection toothpasteDrug
0.243% sodium fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| stannous fluoride toothpaste | Experimental | brush twice a day for 8 weeks Receives: Drug: stannous fluoride toothpaste |
| cavity protection toothpaste | Sham comparator | brush twice a day for 8 weeks Receives: Drug: cavity protection toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque scores
Measured: baseline
plaque scores
Measured: week 8
Secondary outcomes (2)
gingivitis score
Measured: baseline
gingivitis score
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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
- NCT02574221
- Sponsor's protocol ID
- 2015049
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2015
- Last updated
- 6 Oct 2017
- 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 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity
- ClinicalTrials.gov ID
- NCT02574221
- Acronym / sponsor ID
- 2015049
- Conditions
- Plaque, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Oct 2015 (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.
This study is to evaluate the sensitivity of the molecular method and its ability to split a stannous fluoride toothpaste versus a negative control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stannous fluoride toothpaste | Experimental | Drug: stannous fluoride toothpastebrush twice a day for 8 weeks |
| cavity protection toothpaste | Sham comparator | Drug: cavity protection toothpastebrush twice a day for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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 maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time;
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;
- Need an antibiotic prophylaxis prior to dental visits;
- A history of hypersensitivity to oral care products containing stannous fluoride;
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 toothpaste0.454% stannous fluoride toothpaste | Drug | stannous fluoride toothpaste |
| cavity protection toothpaste0.243% sodium fluoride toothpaste | Drug | cavity protection toothpaste |
Primary outcome
plaque scores
Time frame: baseline
plaque scores
Time frame: week 8
2 secondary outcomes
gingivitis score
Time frame: baseline
gingivitis score
Time frame: week 8
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 Oct 2017.
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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 toothpaste and cavity protection toothpaste in people with Plaque and 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 15 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 6 Oct 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. 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?
plaque scores (time frame: baseline). 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?
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 Oct 2017; AzTrials last refreshed its copy on 28 Oct 2026.