N/A Completed N=139 Randomized Triple-blind Treatment

NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study

Tooth Hypersensitivity

Source: ClinicalTrials.gov NCT01669785 ↗

Enrolled (actual)

139

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcomePrimary: Baseline Pre-Prophy Assessment (Tactile Sensitivity) — 10.56; 10.00; 10.98 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 Baseline Pre-Prophy Assessment (Tactile Sensitivity)	10.56; 10.00; 10.98	—
PRIMARY Immediate Sensitivity Relief (Tactile Sensitivity)	19.61; 16.67; 12.01	—
PRIMARY Long-term Sensitivity Relief (Tactile Sensitivity)	19.89; 16.51; 12.07	—
PRIMARY Baseline Pre-Prophy Assessment (Air Blast Sensitivity)	1.72; 1.70; 1.65	—
PRIMARY Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)	0.88; 0.97; 1.72	—
PRIMARY Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)	0.87; 1.11; 1.67	—
SECONDARY Sensitivity Relief (Self-Assessment)	0.82; 0.67; 0.76	—
SECONDARY Post- Scaling Sensitivity Relief (Self-Assessment)	1.31; 0.98; 1.28	—
SECONDARY Post-prophylaxis Sensitivity Relief (Self-Assessment)	1.00; 0.90; 1.09	—
SECONDARY Long-term Sensitivity Relief (Self-Assessment)	0.60; 0.50; 0.72	—

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 /= 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01669785). 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.