CompletedInterventionalNot ApplicableUpdated Aug 31, 2020
A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen | NCT02384044 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 25, 2019
A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen
ClinicalTrials.gov ID
NCT02384044
Lead Sponsor
Procter and GambleINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
30Actual
Last Update Posted
Jun 25, 2019Actual
Start Date
Feb 2015
Primary Completion Date
Mar 2015Actual
Completion Date
Mar 2015Actual
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.
Dentin Sensitivity
Crest® Sensi-Stop™ Strips
Colgate® Sensitivity Relief Pen
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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