Mode
Text Size
Log in / Sign up
N/A Completed N=70 Randomized Single-blind Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search