Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
Overview
- Phase
- Not Applicable
- Intervention
- Stannous fluoride paste
- Conditions
- Dentinal Hypersensitivity
- Sponsor
- Procter and Gamble
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Did Participants Notice a Difference in the Areas Noted?
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
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 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
Arms & Interventions
oxalate liquid, SnF2 paste
Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
Intervention: Stannous fluoride paste
potassium oxalate gel
potassium oxalate gel self applied
Intervention: Potassium Oxalate Gel
oxalate liquid, SnF2 paste
Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
Intervention: Potassium Oxalate Liquid
Outcomes
Primary Outcomes
Did Participants Notice a Difference in the Areas Noted?
Time Frame: Up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
How Satisfied Were Participants With Treatment?
Time Frame: up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Ease of Treatment at Home
Time Frame: Up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.