Phase 3
N=45
Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01072188 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Hypersensitivity to Touch (Tactile) — 42.2; 20.1 Units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Arginine/Calcium Carbonate (Device); Nupro - Fluoride Free (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypersensitivity to Touch (Tactile) |
42.2; 20.1 | 0.05 |
| PRIMARY Air Blast |
1.26; 2.17 | 0.05 |
Summary
The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a pre-procedure to a professional dental cleaning.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects, ages 18-70, inclusive.
- Availability for the three (3) week duration of the study.
- Two (2) sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
- Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50gms. of force.
- Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
- Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
- Good general health with no known allergies to products being tested.
- Use of a non-desensitizing dentifrice for three months prior to entry into the study.
- Signed Informed Consent Form.
Exclusion Criteria
- Gross 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.
- Scheduled dental prophylaxis within three weeks prior to the Baseline Hypersensitivity Examination.
- 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.
- Subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study.
- Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
- Current participation in any other clinical study.
- Pregnant or lactating subjects.
- Allergies to oral care products, personal care consumer products, or their ingredients.
- Medical condition which prohibits not eating/drinking for 4 hours.
Data sourced from ClinicalTrials.gov (NCT01072188). 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.