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

NCT ID: NCT02189382

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-07-31

Brief Summary

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

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Potassium Oxalate Gel

Self Applied

Group Type: EXPERIMENTAL

Potassium Oxalate

Intervention Type: DEVICE

Water

Self Applied

Group Type: OTHER

Water

Intervention Type: OTHER

Interventions

Potassium Oxalate

Intervention Type: DEVICE

Water

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Silverstone Research Group

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

2014029

Identifier Type: -

Identifier Source: org_study_id