NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study

Completed · Not applicable

Conditions studied: Tooth Hypersensitivity

In brief

The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.

Key facts

Study ID

NCT01610167

Run by

Dentsply International

People needed

151

Starts

2011-09-01

Expected to finish

2011-12-01

Last updated by the study team

2013-10-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Availability to complete in the 28 day duration of the study.
• Two sensitive teeth which are not adjacent to each other and preferably in different quadrants and demonstrate cervical erosion, abrasion, and gingival recession.
• qualifying response to tactile stimuli as defined by a score of </= 20 grams.
• Qualifying response to air blast stimuli as defined by a score of >/= 1 on the Schiff Cold Air Sensitivity Scale.
• Good general health with no known allergies to products being tested.
• Use of a non-desensitizing dentifrice for 3 weeks prior to entry into the study.
• Able to follow study procedures and instructions.
• Must have a minimum of 10 natural evaluable teeth, excluding 3rd molars.

You may not qualify if…

• Individuals who exhibit gross oral pathology
• Females who may be pregnant or lactating or intending to become pregnant
• Individuals who require anesthetic during scaling
• Dental pathology which may cause pain similar to tooth sensitivity
• Individuals with large amounts of calculus
• Subjects with active infectious diseases such as hepatitis, HIV or tuberculosis
• Any condition requiring antibiotic prophylaxis for dental treatment
• Excessive gingival inflammation
• Individuals who had their teeth cleaned within 30 days of the screening appointment
• Individuals who have had a desensitizing treatment or tooth bleaching within 90 days of screening appointment.
• Oral pathology, chronic disease, or history of allergy to test products
• Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
• Sensitive teeth with mobility greater than one.
• Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
• Regular use of sedatives, anti-inflammatory drugs, or analgesic
• Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past 4 weeks.
• Current participation in any other clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
• Personnel; a) An employee of the sponsor; b) A member or relative of the study site staff directly involved with the study.
• Allergies to oral care products, personal care consumer products, or their ingredients.
• Any subject who, in the judgment of the investigator, should not participate in the study.

Where it is running

• Salus Research — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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