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

Procter & Gamble (P&G)

Status: Completed

Conditions: Dentin Sensitivity

Treatments: Device: Potassium Oxalate; Device: Power toothbrush; Device: Manual toothbrush; Drug: Stannous fluoride paste

Study type: Interventional

Funder types: Industry

Identifiers

NCT02513212

2015059

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

oxalate liquid, SnF2 paste, manual toothbrush

Other group

Description:

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush

Treatment:

Device: Potassium Oxalate

Drug: Stannous fluoride paste

Device: Manual toothbrush

oxalate liquid, SnF2 paste, power toothbrush

Other group

Description:

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush

Treatment:

Device: Power toothbrush

Device: Potassium Oxalate

Drug: Stannous fluoride paste