Back to resultsResearch on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
Primary Purpose
Dentinal Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potassium Oxalate Gel
Potassium Oxalate Liquid
Stannous fluoride paste
Sponsored by
About this trial
This is an interventional treatment trial for Dentinal Hypersensitivity
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
Sites / Locations
- Tufts University School of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
potassium oxalate gel
oxalate liquid, SnF2 paste
Arm Description
potassium oxalate gel self applied
Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
Outcomes
Primary Outcome Measures
How Satisfied Were Participants With Treatment?
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Ease of Treatment at Home
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02613117
First Posted
November 13, 2015
Last Updated
September 21, 2020
Sponsor
Procter and Gamble
1. Study Identification
Unique Protocol Identification Number
NCT02613117
Brief Title
Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentinal Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
potassium oxalate gel
Arm Type
Other
Arm Description
potassium oxalate gel self applied
Arm Title
oxalate liquid, SnF2 paste
Arm Type
Other
Arm Description
Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
Intervention Type
Device
Intervention Name(s)
Potassium Oxalate Gel
Intervention Description
Self applied
Intervention Type
Device
Intervention Name(s)
Potassium Oxalate Liquid
Intervention Description
Professionally Applied
Intervention Type
Drug
Intervention Name(s)
Stannous fluoride paste
Intervention Description
SnF2 Paste
Primary Outcome Measure Information:
Title
How Satisfied Were Participants With Treatment?
Description
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Time Frame
up to 8 weeks
Title
Ease of Treatment at Home
Description
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Time Frame
Up to 8 weeks
Title
Did Participants Notice a Difference in the Areas Noted?
Description
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
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