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

Not Applicable

Completed

• Conditions: Dentin Sensitivity
• Interventions: Device: Crest® Sensi-Stop™ Strips

• Registration Number: NCT02293044
• Lead Sponsor: Procter and Gamble

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-18
• Results First Submitted: 2019-04-26
• Results First Submitted QC: 2019-04-26
• Results First Posted: 2019-05-21
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Crest® Sensi-Stop™ Strips	Crest® Sensi-Stop™ Strips	Self Applied

Primary Outcome Measures

Name	Time	Method
Change From Baseline Cold Water Challenge	1 Day	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.

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

Trial Locations

Locations (1)

Oral Health Science Center; 🇺🇸 Mason, Ohio, United States