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

Not Applicable

Completed

• Conditions: Dentinal Hypersensitivity
• Interventions: Device: Potassium Oxalate Liquid; Device: Potassium Oxalate Gel; Drug: Stannous fluoride paste

• Registration Number: NCT02613117
• Lead Sponsor: Procter and Gamble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-24
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2020-08-28
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Results First Posted: 2020-09-22
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxalate liquid, SnF2 paste	Potassium Oxalate Liquid	Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
potassium oxalate gel	Potassium Oxalate Gel	potassium oxalate gel self applied
oxalate liquid, SnF2 paste	Stannous fluoride paste	Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied

Primary Outcome Measures

Name	Time	Method
Did Participants Notice a Difference in the Areas Noted?	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?	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	Up to 8 weeks	Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States