A Pilot Study to Assess Nominal Versus Controlled Stimuli on Dentinal Hypersensitivity

Not Applicable

Completed

Brief Summary: This pilot study will evaluate the use of nominal stimuli to assess dentinal hypersensitivity response relative to a clinically-controlled stimulus.

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 examiner applied 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
Crest® Sensi-Stop™ Strips	Crest® Sensi-Stop™ Strips	Professionally Applied

Primary Outcome Measures

Name	Time	Method
Change From Baseline for Dentin Sensitivity Cold Water as Assessed by the Schiff Index	Day 1	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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
Change From Baseline for Visual Analog Scale - Cold Water	Day 1	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.
Change From Baseline for 5 Face Emoticon Scale	Day 2	Scale to score their comfort/discomfort that ranges from -2 to +2 where a -2 is considered very comfortable and a +2 is considered very uncomfortable.