Clinical trial NCT01072188: Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
Official title: Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypersensitivity
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2010-02-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Hypersensitivity to Touch (Tactile)
timeFrame: Immediately after product application
measure: Air Blast
timeFrame: Immediately after product application
Secondary outcomes:
Other outcomes:
Locations:
city: Langhorne
country: United States
facility: Contract Dental Evaluations
state: Pennsylvania
Study officials:
affiliation: Contract Dental Evaluations
name: David Hamlin, DDS
role: PRINCIPAL_INVESTIGATOR
References: