N/A
Completed N=70
Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity
Dentin Sensitivity
Source: ClinicalTrials.gov NCT02189382 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Change From Baseline Air Challenge — -1.200; -0.086 units on a scale
Summary
This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Air Challenge |
-1.200; -0.086 | — |
| SECONDARY Change From Baseline in Tactile Threshold |
16.857; 0.286 | — |
Eligibility Criteria
Inclusion Criteria
- be at least 18 years of age;
- provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- complete a confidentiality disclosure agreement;
- be in good general health as determined by the Investigator/designee;
- agree not to participate in any other oral/dental product studies during the course of this study;
- agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
- agree to refrain from the use of any non-study oral hygiene products;
- agree to return for all scheduled visits and follow study procedures; and.
- have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge
Exclusion Criteria
- self-reported pregnancy or nursing;
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- active treatment of periodontitis;
- fixed facial orthodontic appliances;
- a history of kidney stones;
- known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
- any diseases or conditions that might interfere with the safe completion of the study; or
- an inability to undergo any study procedures.
Data sourced from ClinicalTrials.gov (NCT02189382). 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.