Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity

Procter & Gamble (P&G)

Status

Completed

Conditions

Dentin Sensitivity

Treatments

Device: Potassium Oxalate

Other: Water

Study type

Interventional

Funder types

Industry

Identifiers

2014029

Details and patient eligibility

About

This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

be at least 18 years of age;
provide written informed consent prior to participation and be given a signed copy of the informed consent form;
complete a confidentiality disclosure agreement;
be in good general health as determined by the Investigator/designee;
agree not to participate in any other oral/dental product studies during the course of this study;
agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
agree to refrain from the use of any non-study oral hygiene products;
agree to return for all scheduled visits and follow study procedures; and.
have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge

Exclusion criteria

self-reported pregnancy or nursing;
severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
active treatment of periodontitis;
fixed facial orthodontic appliances;
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
any diseases or conditions that might interfere with the safe completion of the study; or
an inability to undergo any study procedures.