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

Not Applicable

Completed

Interventions: Device: Colgate® Sensitivity Relief Pen
Device: Crest® Sensi-Stop™ Strips

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Colgate® Sensitivity Relief Pen	Colgate® Sensitivity Relief Pen	Professionally Applied
Crest® Sensi-Stop™ Strips	Crest® Sensi-Stop™ Strips	Professionally Applied

Primary Outcome Measures

Name	Time	Method
Change From Baseline Visual Analog Scale	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline for Air Challenge	1 Day	The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.