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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dentinal Hypersensitivity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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potassium oxalate gel

potassium oxalate gel self applied

Group Type OTHER

Potassium Oxalate Gel

Intervention Type DEVICE

Self applied

oxalate liquid, SnF2 paste

Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied

Group Type OTHER

Potassium Oxalate Liquid

Intervention Type DEVICE

Professionally Applied

Stannous fluoride paste

Intervention Type DRUG

SnF2 Paste

Interventions

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Potassium Oxalate Gel

Self applied

Intervention Type DEVICE

Potassium Oxalate Liquid

Professionally Applied

Intervention Type DEVICE

Stannous fluoride paste

SnF2 Paste

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes