A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene

Study Overview
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Brief Summary
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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
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Oral Malodor

Intervention / Treatment
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* Drug: Stannous fluoride toothpaste
* Drug: Potassium nitrate toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two-Step stannous fluoride toothpaste<br>Two-Step stannous fluoride toothpaste | Drug: Stannous fluoride toothpaste<br> <br> |
| Active Comparator: Potassium nitrate toothpaste<br>Potassium nitrate toothpaste | Drug: Potassium nitrate toothpaste<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath odor | Breath measured using a hedonic malodor evaluation | Baseline | 
| Breath odor | Breath measured using a hedonic malodor evaluation | 2 Weeks |