Clinical trial NCT01610167: NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study
Official title: NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Hypersensitivity
Lead sponsor: Dentsply Sirona Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

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 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.

Primary outcomes:
measure: Immediate Sensitivity Relief. Tactile Sensitivity.
timeFrame: Immediately after treatment.
measure: Adverse Events.
timeFrame: Immediately after treatment to 28 days (+/- 2 days) post treatment.
measure: Immediate Sensitivity Relief. Air Blast Sensitivity.
timeFrame: Immediately after treatment.
Secondary outcomes:
measure: Extended Sensitivity Relief. Tactile Sensitivity.
timeFrame: 28 days (+/- 2 days) post treatment.
measure: Extended Sensitivity Relief. Air Blast Sensitivity.
timeFrame: 28 days (+/- 2 days) post treatment.
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
affiliation: Salus Research
name: Jeffery L. Milleman, DDS, MPA
role: PRINCIPAL_INVESTIGATOR
affiliation: Salus Research
name: Kimberly R. Milleman, ASDH, MS
role: PRINCIPAL_INVESTIGATOR
References: