N/A
Completed N=30
A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen
Dentin Sensitivity
Source: ClinicalTrials.gov NCT02384044 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Change From Baseline Visual Analog Scale — -22.933; -3.200 Units on a scale
Summary
This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Visual Analog Scale |
-22.933; -3.200 | — |
| SECONDARY Change From Baseline for Air Challenge |
-0.800; 0.000 | — |
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 delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
- 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 dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the cold water challenge
Exclusion Criteria
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- active treatment for periodontitis
- any diseases or conditions that might interfere with the subject safely completing the study
- inability to undergo study procedures
- fixed facial orthodontic appliances
- a history of kidney stones
- self-reported pregnancy or nursing
- known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
Data sourced from ClinicalTrials.gov (NCT02384044). 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.