N/A
Completed N=151
NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study
Tooth Hypersensitivity
Source: ClinicalTrials.gov NCT01610167 ↗
Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Immediate Sensitivity Relief. Tactile Sensitivity. — 12.36; 10.46; 0.60 grams
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immediate Sensitivity Relief. Tactile Sensitivity. |
12.36; 10.46; 0.60 | — |
| PRIMARY Adverse Events. |
0; 0; 0 | — |
| PRIMARY Immediate Sensitivity Relief. Air Blast Sensitivity. |
-0.87; -0.86; 0.00 | — |
| SECONDARY Extended Sensitivity Relief. Tactile Sensitivity. |
10.19; 11.07; 1.15 | — |
| SECONDARY Extended Sensitivity Relief. Air Blast Sensitivity. |
-0.94; -0.95; 0.03 | — |
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 /= 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.
Data sourced from ClinicalTrials.gov (NCT01610167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.