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Completed

NCT Number: NCT02189382

Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity

This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on 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

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;
  • 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.

Treatment and study plan

Potassium oxalate

Device

Water

Other

Primary outcomes

  1. Change From Baseline Air Challenge

    Time frame: 30 days

    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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.

Secondary outcomes

  1. Change From Baseline in Tactile Threshold

    Time frame: 30 days

    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
2014
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2014
Registry last updated
Aug 20, 2018

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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