A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

Procter & Gamble (P&G)

Status: Completed

Conditions: Dentin Sensitivity

Treatments: Drug: Stannous fluoride paste; Drug: Sodium fluoride paste; Device: Potassium oxalate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02221349

2014069

Details and patient eligibility

About

This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.

Enrollment: 30 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 confidentiality disclosure agreement
• Be in good general health as determined by the Investigator/designee
• Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the 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
• Fixed facial orthodontic appliances
• A history of kidney stones
• Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
• Any diseases or conditions that might interfere with the safe completion of the study
• An inability to undergo any study procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

oxalate liquid & gel plus SnF2 paste

Other group

Description:

Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied

Treatment:

Device: Potassium oxalate

Drug: Stannous fluoride paste

oxalate liquid & gel plus NaF paste

Other group

Description:

Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied

Treatment:

Device: Potassium oxalate

Drug: Sodium fluoride paste