N/A
Completed N=104
Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
Dentinal Hypersensitivity
Source: ClinicalTrials.gov NCT02613117 ↗
Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: How Satisfied Were Participants With Treatment? — 0; 1; 2; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY How Satisfied Were Participants With Treatment? |
0; 1; 2; 2; 7; 11 | — |
| PRIMARY Ease of Treatment at Home |
0; 0; 1; 0; 2; 12 | — |
| PRIMARY Did Participants Notice a Difference in the Areas Noted? |
42; 30; 14; 14; 19; 9 | — |
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
Data sourced from ClinicalTrials.gov (NCT02613117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.