A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen

Completed · Not applicable

Conditions studied: Dentin Sensitivity

In brief

This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.

Key facts

Study ID

NCT02384044

Run by

Procter and Gamble

People needed

30

Starts

2015-02-01

Expected to finish

2015-03-01

Last updated by the study team

2019-06-25

Who can join

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

You may qualify if…

• be at least 18 years of age
• sign an informed consent form and be given a copy
• be in good general health as determined by the Investigator/designee
• agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
• agree to not participate in any other oral care study for the duration of this study
• agree to return for scheduled visits and follow all study procedures
• have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the cold water challenge

You may not qualify if…

• severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
• active treatment for periodontitis
• any diseases or conditions that might interfere with the subject safely completing the study
• inability to undergo study procedures
• fixed facial orthodontic appliances
• a history of kidney stones
• self-reported pregnancy or nursing
• known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate

Where it is running

• Oral Health Science Center — Mason, Ohio, United States

Full record on ClinicalTrials.gov

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