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

Procter & Gamble (P&G)

Status

Completed

Conditions

Dentin Sensitivity

Treatments

Device: Crest® Sensi-Stop™ Strips

Device: Colgate® Sensitivity Relief Pen

Study type

Interventional

Funder types

Industry

Identifiers

NCT02384044

2015012

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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