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

Procter and Gamble1 site in 1 country30 target enrollmentFebruary 2015

ConditionsDentin Sensitivity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dentin Sensitivity
Sponsor: Procter and Gamble
Enrollment: 30
Locations: 1
Primary Endpoint: Change From Baseline Visual Analog Scale
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

March 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Procter and Gamble

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change From Baseline Visual Analog Scale

Time Frame: 1 Day

Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.