A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene
Not Applicable
Completed
- Conditions
- Oral Malodor
- Interventions
- Drug: Stannous fluoride toothpaste
- Registration Number
- NCT02613130
- Lead Sponsor
- Procter and Gamble
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Potassium nitrate toothpaste Potassium nitrate toothpaste Potassium nitrate toothpaste Two-Step stannous fluoride toothpaste Stannous fluoride toothpaste Two-Step stannous fluoride toothpaste
- Primary Outcome Measures
Name Time Method Breath odor 2 Weeks Breath measured using a hedonic malodor evaluation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Health Resources Group
🇺🇸Whittier, California, United States