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

Dentinal Hypersensitivity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613117
• Other study ID #: 2014067
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2020
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dentinal Hypersensitivity
• Hypersensitivity

Intervention

Device:
• Potassium Oxalate Gel
Self applied
• Potassium Oxalate Liquid
Professionally Applied

Drug:
• Stannous fluoride paste
SnF2 Paste

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	How Satisfied Were Participants With Treatment?	Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.	up to 8 weeks
Primary	Ease of Treatment at Home	Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.	Up to 8 weeks
Primary	Did Participants Notice a Difference in the Areas Noted?	Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.	Up to 8 weeks