NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study

Dentsply

Status: Completed

Conditions: Tooth Hypersensitivity

Treatments: Device: Group B; Device: Group C; Device: Group A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01669785

CTP-002

Details and patient eligibility

About

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.

Full description

It is hypothesized that the prophy paste with Novamin will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.

Enrollment: 139 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Availability to complete in the 28 day duration.
• Two sensitive teeth, which are not adjacent to each other and preferably in different quadrants, which 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.
• Subjects need to satisfy the qualifying response to stimuli for both parameters assesses (Tactile or Air Blast) on at least two teeth (non-adjacent) to be entered into the study.
• Good general health with no known allergies to products being tested.
• Use of a non-desensitizing dentifrice for 2 weeks prior to entry into the study.
• Subjects must have a minimum of 10 natural teeth, excluding 3rd molars.

Exclusion criteria

• 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 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; b0 A member or relative of teh study site staff directly involved with the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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139 participants in 3 patient groups

Group C

Active Comparator group

Description:

NUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate.

Treatment:

Device: Group C

Group A

Experimental group

Description:

NUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate

Treatment:

Device: Group B

Group B

Experimental group

Description:

NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate.

Treatment:

Device: Group A