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

NCT02613130 | Completed

• 1 other identifier: 2015110
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Breath odor

  Breath measured using a hedonic malodor evaluation

  Baseline

• Breath odor

  Breath measured using a hedonic malodor evaluation

  2 Weeks

Study Arms (2)

Two-Step stannous fluoride toothpaste

EXPERIMENTAL

Two-Step stannous fluoride toothpaste

Drug: Stannous fluoride toothpaste

Potassium nitrate toothpaste

ACTIVE COMPARATOR

Potassium nitrate toothpaste

Drug: Potassium nitrate toothpaste

Interventions

Stannous fluoride toothpaste DRUG

Two-Step stannous fluoride toothpaste

Potassium nitrate toothpaste DRUG

Potassium nitrate toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

University Health Resources Group

Whittier, California, 90604, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

US (1)