N/A
N=79
Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction
Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01040169 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: Tooth Hypersensitity to Touch Stimuli (Tactile) — 10.83; 10.63 Units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arginine/Calcium Carbonate (Device); Mint Prophy paste - 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 Tooth Hypersensitity to Touch Stimuli (Tactile) |
10.83; 10.63 | 0.05 |
| PRIMARY Tooth Hypersensivity Stimuli to Air |
2.69; 2.73 | 0.05 |
Summary
Tooth sensitivity reduction after dentifrices use
Eligibility Criteria
Inclusion Criteria
- Male and female subjects, ages 18-70, inclusive.
- Availability for the three month duration of the study.
- Two 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.
- 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 (NCT01040169). 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.