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

NCT ID: NCT02613130

Last Updated: 2017-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Oral Malodor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Two-Step stannous fluoride toothpaste

Two-Step stannous fluoride toothpaste

Group Type: EXPERIMENTAL

Stannous fluoride toothpaste

Intervention Type: DRUG

Potassium nitrate toothpaste

Potassium nitrate toothpaste

Group Type: ACTIVE_COMPARATOR

Potassium nitrate toothpaste

Intervention Type: DRUG

Interventions

Stannous fluoride toothpaste

Intervention Type: DRUG

Potassium nitrate toothpaste

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Health Resources Group

Whittier, California, United States

Countries

United States

Other Identifiers

2015110

Identifier Type: -

Identifier Source: org_study_id