Clinical Study to Assess the Efficacy of New Toothpaste Containing SnF as Compared to Colgate Cavity Protection Toothpaste on the Reduction of Enamel Erosion
Purpose
The goal of this clinical trial is to learn if a new toothpaste can prevent enamel erosion in healthy adults. Researchers will compare the test toothpaste to a control toothpaste to see if there is a difference in erosion levels. Participants will brush twice a day for two minutes with their assigned toothpaste.
Condition
- Enamel Erosion
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Sign an Informed Consent Form; - Male or female 18 to 70 years of age, inclusive; - Be in good general health as determined by the study investigators; - Available for the eighteen (18) days duration of the study; - Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively) ascertained from a preliminary saliva examination; - Have healthy salivary pH (unstimulated saliva pH 6.8-7.8) ascertained from a preliminary saliva test; - Must be able to accept a well-fitting removable intraoral appliance bearing at least two enamel specimens.
Exclusion Criteria
- Gross oral pathology, chronic disease, and/or history of allergies to any of the test products; - Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study; - Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months; - Obvious signs of dental erosion Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures; - Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, daily use of analgesics, or medication which alters salivary flow - Participation in any other oral clinical study for the duration of this study - Self-reported pregnancy and/or currently breastfeeding; - Allergies to oral care products, personal care consumer products, and/or their ingredients; - Medical condition which prohibits not eating/drinking for 4 hours.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Test |
Participants will brush with a new toothpaste Containing SnF for two minutes twice daily. |
|
|
Placebo Comparator Control |
Participants will brush with a regular fluoride toothpaste for two minutes twice daily. |
|
Recruiting Locations
School of Dentistry, University of Texas Health San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Colgate Palmolive
Study Contact
Detailed Description
The objective of this clinical study is to assess the efficacy of New Toothpaste Containing SnF as compared to commercially available toothpaste in the reduction of enamel erosion over a ten (10) days period. This investigation will be a randomized, double-blinded, single-center, parallel clinical study. Subjects will be randomly assigned to one of the two study groups, and will be instructed to use their assigned toothpaste for a period of ten (10) days.