GingivitisPhase 4NCT03936569
A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice
A Phase 4 study testing Marketed Toothpaste and Marketed Cavity Protection Toothpaste in people with Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to 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
- Gingivitis
- What is being tested?
- Marketed Toothpaste and Marketed Cavity Protection Toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 25 Jan 2019
- Phase
- Phase 4
- 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 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 16 gradable teeth;
- 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 antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
- Have 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;
- Removable oral appliances;
- Fixed facial or lingual orthodontic appliances;
- Self-reported pregnancy or lactation;
- Any diseases or condition that might interfere with the safe participation in the study; and
- Inability to undergo study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 3-Month Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice
The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.
- Conditions
- Gingivitis
- Being tested
- Marketed Toothpaste, Marketed Cavity Protection Toothpaste
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed ToothpasteDrug
Marketed stannous fluoride (0.454%) toothpaste
Marketed Cavity Protection ToothpasteDrug
Marketed sodium monofluorophosphate (0.76 %) toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Marketed Stannous Fluoride Toothpaste | Experimental | Brush twice daily Receives: Drug: Marketed Toothpaste |
| Marketed Cavity Protection Toothpaste | Placebo comparator | Brush twice daily Receives: Drug: Marketed Cavity Protection Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Baseline
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: 1 Month
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
Secondary outcomes (3)
Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Measured: Baseline
Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Measured: 1 Month
Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start29 Oct 2018
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT03936569
- Sponsor's protocol ID
- 2018122
- Status last verified
- Jun 2023
- First submitted
- 1 May 2019
- Last updated
- 8 Jun 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 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Month Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice
- ClinicalTrials.gov ID
- NCT03936569
- Acronym / sponsor ID
- 2018122
- Conditions
- Gingivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 3 May 2019 (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 clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marketed Stannous Fluoride Toothpaste | Experimental | Drug: Marketed ToothpasteBrush twice daily |
| Marketed Cavity Protection Toothpaste | Placebo comparator | Drug: Marketed Cavity Protection ToothpasteBrush twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 16 gradable teeth;
- Agree to return for scheduled visits and follow the study procedures;
Key exclusion criteria (7 listed)
- Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
- Have 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;
- Removable oral appliances;
- Fixed facial or lingual orthodontic appliances;
- Self-reported pregnancy or lactation;
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 |
|---|---|---|
| Marketed ToothpasteMarketed stannous fluoride (0.454%) toothpaste | Drug | Marketed Stannous Fluoride Toothpaste |
| Marketed Cavity Protection ToothpasteMarketed sodium monofluorophosphate (0.76 %) toothpaste | Drug | Marketed Cavity Protection Toothpaste |
Primary outcome
Löe-Silness Gingivitis Evaluation
Time frame: Baseline
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).
Löe-Silness Gingivitis Evaluation
Time frame: 1 Month
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).
Löe-Silness Gingivitis Evaluation
Time frame: 3 Months
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).
3 secondary outcomes
Turesky Modified Quigley-Hein Index
Time frame: Baseline
Turesky Modified Quigley-Hein Index
Time frame: 1 Month
Turesky Modified Quigley-Hein Index
Time frame: 3 Months
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 8 Jun 2023.
Related trials for Gingivitis
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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 Phase 4 study testing Marketed Toothpaste and Marketed Cavity Protection Toothpaste 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 7 inclusion and 7 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 8 Jun 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Löe-Silness Gingivitis Evaluation (time frame: Baseline). The study lists 3 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 8 Jun 2023.