Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 13, 2015
CompletedFirst Posted
Study publicly available on registry
November 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
September 22, 2020
CompletedSeptember 22, 2020
September 1, 2020
7 months
November 13, 2015
August 28, 2020
September 21, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
potassium oxalate gel
OTHERpotassium oxalate gel self applied
oxalate liquid, SnF2 paste
OTHERPotassium oxalate liquid professionally applied, Stannous fluoride paste self applied
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111, United States
Results Point of Contact
- Title
- Clinical Trial Manager
- Organization
- Procter and Gamble
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2015
First Posted
November 24, 2015
Study Start
November 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
September 22, 2020
Results First Posted
September 22, 2020
Record last verified: 2020-09