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Completed

NCT Number: NCT02293044

A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity

This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.

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Key information

Conditions

Dentin Sensitivity Hypersensitivity Immune System Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral Health Science Center

Mason, Ohio, 45040, 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
  • have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale 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
  • self-reported pregnancy or nursing
  • 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.

Treatment and study plan

Crest® Sensi-Stop™ Strips

Device

Primary outcomes

  1. Change From Baseline Cold Water Challenge

    Time frame: 1 Day

    The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water 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 Visual Analog Scale

    Time frame: 1 Day

    Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

A Pilot Clinical Study to Evaluate the Safety and Efficacy of a Self-Applied Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2014
Registry last updated
Jun 25, 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.

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