GingivitisNCT06140784
A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices
A study testing 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice in people with Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition. 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?
- 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2023to 10 Dec 2023
- 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 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;
- Have mild to moderate gingivitis with at least 20 bleeding sites;
- Agree to return for scheduled visits and follow the study procedures;
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- 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;
- Agree to refrain from any oral hygiene the morning of your visit
- Agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing.
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;
- Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
- 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 Three-Month Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices
The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.
- Conditions
- Gingivitis
- Being tested
- 0.76% Sodium Monofluorophosphate Dentifrice, 0.454% Stannous Fluoride Dentifrice
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.76% Sodium Monofluorophosphate DentifriceDrug
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
0.454% Stannous Fluoride DentifriceDrug
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
0.454% Stannous Fluoride DentifriceDrug
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
0.454% Stannous Fluoride DentifriceDrug
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| 0.76% Sodium Monofluorophosphate Dentifrice | Sham comparator | Not described Receives: Drug: 0.76% Sodium Monofluorophosphate Dentifrice |
| Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice | Active comparator | Not described Receives: Drug: 0.454% Stannous Fluoride Dentifrice |
| Marketed 0.454% Stannous Fluoride Dentifrice | Active comparator | Not described Receives: Drug: 0.454% Stannous Fluoride Dentifrice |
| 0.454% Stannous Fluoride Dentifrice | Active comparator | Not described Receives: Drug: 0.454% Stannous Fluoride Dentifrice |
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: 3 Months
Secondary outcomes (5)
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
Mean Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
Measured: Baseline
Mean Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
Measured: 1 Month
Mean Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the 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 posted20 Nov 2023
- Study start2 Sep 2023
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 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
- NCT06140784
- Sponsor's protocol ID
- 2023043
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2023
- Last updated
- 1 Mar 2024
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Month Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices
- ClinicalTrials.gov ID
- NCT06140784
- Acronym / sponsor ID
- 2023043
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 20 Nov 2023 (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 primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.76% Sodium Monofluorophosphate Dentifrice | Sham comparator | Drug: 0.76% Sodium Monofluorophosphate Dentifrice |
| Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice | Active comparator | Drug: 0.454% Stannous Fluoride Dentifrice |
| Marketed 0.454% Stannous Fluoride Dentifrice | Active comparator | Drug: 0.454% Stannous Fluoride Dentifrice |
| 0.454% Stannous Fluoride Dentifrice | Active comparator | Drug: 0.454% Stannous Fluoride Dentifrice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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;
- Have mild to moderate gingivitis with at least 20 bleeding sites;
Key exclusion criteria (8 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;
- Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
- Removable oral appliances;
- Fixed facial or lingual orthodontic appliances;
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 |
|---|---|---|
| 0.76% Sodium Monofluorophosphate DentifriceWhole mouth brushing with a toothpaste, twice daily for the duration of the study. | Drug | 0.76% Sodium Monofluorophosphate Dentifrice |
| 0.454% Stannous Fluoride DentifriceWhole mouth brushing with a toothpaste, twice daily for the duration of the study. | Drug | Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice |
| 0.454% Stannous Fluoride DentifriceWhole mouth brushing with a toothpaste, twice daily for the duration of the study. | Drug | Marketed 0.454% Stannous Fluoride Dentifrice |
| 0.454% Stannous Fluoride DentifriceWhole mouth brushing with a toothpaste, twice daily for the duration of the study. | Drug | 0.454% Stannous Fluoride Dentifrice |
Primary outcome
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).
5 secondary outcomes
Löe-Silness Gingivitis Evaluation
Time frame: Baseline
Löe-Silness Gingivitis Evaluation
Time frame: 1 Month
Mean Turesky Modified Quigley-Hein Index
Time frame: Baseline
Mean Turesky Modified Quigley-Hein Index
Time frame: 1 Month
Mean 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 1 Mar 2024.
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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 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice 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 10 inclusion and 8 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 1 Mar 2024. 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?
Löe-Silness Gingivitis Evaluation (time frame: 3 Months). 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 1 Mar 2024.