Skip to main content
OpenTrials
Completed

NCT Number: NCT02481557

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Silverstone Research Group

Las Vegas, Nevada, 89146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxalate Salt Solution

Device

Applied by dentist

Primary outcomes

  1. Change From Baseline Air Challenge

    Time frame: 10 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 outcomes

  1. Change From Baseline for Yeaple Probe

    Time frame: 10 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.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2015
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.