Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity

Procter & Gamble (P&G)

Status: Completed

Conditions: Dentinal Hypersensitivity

Treatments: Drug: Stannous fluoride paste; Device: Potassium Oxalate Liquid; Device: Potassium Oxalate Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02613117

2014067

Details and patient eligibility

About

This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 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 at least one tooth at risk for hypersensitivity.

Exclusion criteria

• any medical condition requiring pre-medication prior to dental procedures
• any diseases or conditions that might interfere with the subject safely completing the study
• inability to undergo study procedures
• a history of kidney stones
• have self-reported pregnancy or nursing
• known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, or potassium sorbate

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

potassium oxalate gel

Other group

Description:

potassium oxalate gel self applied

Treatment:

Device: Potassium Oxalate Gel

oxalate liquid, SnF2 paste

Other group

Description:

Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied

Treatment:

Device: Potassium Oxalate Liquid

Drug: Stannous fluoride paste