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

Completed · Not applicable

Conditions studied: Oral Malodor

In brief

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.

Key facts

Study ID

NCT02613130

Run by

Procter and Gamble

People needed

60

Starts

2015-11-01

Expected to finish

2015-12-01

Last updated by the study team

2017-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Health Resources Group — Whittier, California, United States

Full record on ClinicalTrials.gov

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