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

Oral Malodor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613130
• Other study ID #: 2015110
• Status: Completed
• Phase: N/A
• First received: November 13, 2015
• Last updated: September 29, 2017
• Start date: November 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Malodor

Intervention

Drug:
• Stannous fluoride toothpaste

• Potassium nitrate toothpaste

Locations

Country	Name	City	State
United States	University Health Resources Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath odor	Breath measured using a hedonic malodor evaluation	Baseline
Primary	Breath odor	Breath measured using a hedonic malodor evaluation	2 Weeks