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OpenTrials
Completed

NCT Number: NCT02513212

A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes

This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.

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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 photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;
  • be in good general health as determined by the Investigator/designee; and
  • have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool 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;
  • 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

Professionally applied liquid

Stannous fluoride paste

Drug

SnF2 Paste

Manual toothbrush

Device

Marketed manual toothbrush

Power toothbrush

Device

Marketed power toothbrush

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 Visual Analog Scale

    Time frame: 30 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2015
Registry last updated
Aug 31, 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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