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Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis

Not Applicable
Completed
Conditions
Dentin Sensitivity
Interventions
Device: Oxalate Salt Solution
Registration Number
NCT02481557
Lead Sponsor
Procter and Gamble
Brief Summary

This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
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, 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 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
  • 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 orthodontic appliances

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Oxalate Salt SolutionOxalate Salt SolutionProfessionally applied
Primary Outcome Measures
NameTimeMethod
Change From Baseline Air Challenge10 Minutes

The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.

Secondary Outcome Measures
NameTimeMethod
Change From Baseline for Yeaple Probe10 Minutes

Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.

Trial Locations

Locations (1)

Silverstone Research Group

🇺🇸

Las Vegas, Nevada, United States

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