NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study
Tooth Hypersensitivity
About this trial
This is an interventional treatment trial for Tooth Hypersensitivity
Eligibility Criteria
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.
Sites / Locations
- Salus Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Group C
Group A
Group B
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.
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
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.