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OpenTrials
Completed

NCT Number: NCT02613117

Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity

This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.

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Key information

Conditions

Dentinal Hypersensitivity

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

  • 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
  • agree to not participate in any other oral care study for the duration of this study
  • agree to return for scheduled visits and follow all study procedures
  • have at least one tooth at risk for hypersensitivity.

Exclusion criteria

  • any medical condition requiring pre-medication prior to dental procedures
  • any diseases or conditions that might interfere with the subject safely completing the study
  • inability to undergo study procedures
  • a history of kidney stones
  • have self-reported pregnancy or nursing
  • known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, or potassium sorbate

Treatment and study plan

Potassium Oxalate Gel

Device

Self applied

Potassium Oxalate Liquid

Device

Professionally Applied

Stannous fluoride paste

Drug

SnF2 Paste

Primary outcomes

  1. How Satisfied Were Participants With Treatment?

    Time frame: up to 8 weeks

    Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.

  2. Ease of Treatment at Home

    Time frame: Up to 8 weeks

    Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.

  3. Did Participants Notice a Difference in the Areas Noted?

    Time frame: Up to 8 weeks

    Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2015
Registry last updated
Sep 22, 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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