A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity

Procter and Gamble15 enrolled

Overview

This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dentin Sensitivity

Interventions

Crest® Sensi-Stop™ StripsDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale 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 * self-reported pregnancy or nursing * a history of kidney stones * known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate.

Locations (1)

Oral Health Science Center

Mason, Ohio, United States

Outcomes

Primary Outcomes

Change From Baseline Cold Water Challenge

The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water 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.

Time frame: 1 Day

Secondary Outcomes

Change From Baseline Visual Analog Scale

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. The mean change from Baseline was calculated for this measure.

Time frame: 1 Day

Data from ClinicalTrials.gov

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