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Completed

NCT Number: NCT02152826

Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity

This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing 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

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provide written informed consent to participate in the study
  • Be at least 18 years of age
  • Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
  • Agree to refrain from participating in any other oral/dental product studies for the duration of the study
  • Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
  • Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
  • Agree to comply with study/product usage instructions; and
  • Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion criteria

  • Gross oral neglect or urgent dental treatment needs
  • Severe periodontal disease and/or generalized mobility
  • Active treatment for periodontitis
  • Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
  • Self-reported pregnancy or nursing

Treatment and study plan

Potassium oxalate

Device

Professional application

Primary outcomes

  1. Change From Baseline for Air Challenge

    Time frame: 36 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 Dentin Sensitivity

    Time frame: 36 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 Clinical Study Comparing the Safety and Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Existing Dentinal Hypersensitivity

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 2, 2014
Registry last updated
Sep 18, 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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