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

Procter & Gamble (P&G) logo

Procter & Gamble (P&G)

Status

Completed

Conditions

Dentinal Hypersensitivity

Treatments

Drug: Stannous fluoride paste
Device: Potassium Oxalate Liquid
Device: Potassium Oxalate Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02613117
2014067

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

potassium oxalate gel
Other group
Description:
potassium oxalate gel self applied
Treatment:
Device: Potassium Oxalate Gel
oxalate liquid, SnF2 paste
Other group
Description:
Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
Treatment:
Device: Potassium Oxalate Liquid
Drug: Stannous fluoride paste

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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