Oral MalodorNCT02613130
A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene
A study testing Stannous fluoride toothpaste and Potassium nitrate toothpaste in people with Oral Malodor, run by Procter and Gamble at 1 site in United States.
Trial summary
This study will assess changes in oral malodor and other factors in response to using a two-step toothpaste oral hygiene relative to a sensitivity whitening toothpaste. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Malodor
- What is being tested?
- Stannous fluoride toothpaste and Potassium nitrate toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 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
- 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 an average hedonic score of at least 6.5;
- Have at least 16 gradable teeth;
- Have at least 10 bleeding sites;
Show all 14Show fewer
- Have a Lobene composite stain score of ≥1 on at least 1 tooth;
- Have at least one test tooth with recession and a score of 6 or greater on the nine-point comfort/discomfort sensitivity scale;
- 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 refrain from tongue brushing for the duration of the study;
- Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study;
- Agree to abstain from eating, drinking, chewing gum, using tobacco products, and any oral hygiene at least eight hours prior to evaluation of oral malodor; and
- Agree to refrain from using deodorant, body lotion/powder/spray, hair products, perfume/cologne, lipstick/gloss, or any other scented products on the mornings of the evaluation days prior to their visit to the clinic.
Who cannot join
- Oral malodor of systemic origin as determined by health history or examination;
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- Active treatment for periodontitis;
- Removable oral appliances;
- Fixed facial or lingual orthodontic appliances;
- Antibiotic use within four weeks of the Screening visit;
- Any disease 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.
United States1 site
University Health Resources Group
Whittier, California, 90604
About this study
This study will assess changes in oral malodor and other factors in response to using a two-step toothpaste oral hygiene relative to a sensitivity whitening toothpaste.
- Conditions
- Oral Malodor
- Being tested
- Stannous fluoride toothpaste, Potassium nitrate toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous fluoride toothpasteDrug
Potassium nitrate toothpasteDrug
| Study group | Role | What they receive |
|---|---|---|
| Two-Step stannous fluoride toothpaste | Experimental | Two-Step stannous fluoride toothpaste Receives: Drug: Stannous fluoride toothpaste |
| Potassium nitrate toothpaste | Active comparator | Potassium nitrate toothpaste Receives: Drug: Potassium nitrate toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath odor
Breath measured using a hedonic malodor evaluation
Measured: Baseline
Breath odor
Breath measured using a hedonic malodor evaluation
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MalodorStudies 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
- 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
- NCT02613130
- Sponsor's protocol ID
- 2015110
- Status last verified
- Sep 2017
- First submitted
- 13 Nov 2015
- Last updated
- 3 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 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene
- ClinicalTrials.gov ID
- NCT02613130
- Acronym / sponsor ID
- 2015110
- Conditions
- Oral Malodor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Nov 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 will assess changes in oral malodor and other factors in response to using a two-step toothpaste oral hygiene relative to a sensitivity whitening toothpaste.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-Step stannous fluoride toothpaste | Experimental | Drug: Stannous fluoride toothpasteTwo-Step stannous fluoride toothpaste |
| Potassium nitrate toothpaste | Active comparator | Drug: Potassium nitrate toothpastePotassium nitrate toothpaste |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 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 an average hedonic score of at least 6.5;
- Have at least 16 gradable teeth;
Key exclusion criteria (8 listed)
- Oral malodor of systemic origin as determined by health history or examination;
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- Active treatment for periodontitis;
- 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 |
|---|---|---|
| Stannous fluoride toothpaste | Drug | Two-Step stannous fluoride toothpaste |
| Potassium nitrate toothpaste | Drug | Potassium nitrate toothpaste |
Primary outcome
Breath odor
Time frame: Baseline
Breath measured using a hedonic malodor evaluation
Breath odor
Time frame: 2 Weeks
Breath measured using a hedonic malodor evaluation
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 3 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 Potassium nitrate toothpaste in people with Oral Malodor, 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 14 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 3 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. 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?
Breath odor (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 3 Oct 2017.