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Completed

NCT Number: NCT02221349

A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.

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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

Chad J Anderson DMD Inc

Fresno, California, 93730, 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
  • Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air 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
  • An inability to undergo any study procedures.

Treatment and study plan

Potassium oxalate

Device

Professionally applied (liquid) and self applied (gel)

Sodium fluoride paste

Drug

Toothpaste used by subject

Other names: NaF paste

Stannous fluoride paste

Drug

Toothpaste used by subject

Other names: SnF2 paste

Primary outcomes

  1. Change From Baseline Air Challenge

    Time frame: 60 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/subjects responds to stimulus and requests discontinuation or moves from 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 Visual Analog Scale

    Time frame: 60 days

    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.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2014
Registry last updated
Sep 9, 2020

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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