Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model.
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Colgate Palmolive
- Primary Endpoint
- Mineral Change (delta Z)
Study Overview
Brief Summary
This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and/or female subjects 18 to 50 years inclusive
- •Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
- •Willing to wear retainer 24 hours per day
- •No active, unrestored cavities
- •Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry
- •Available throughout entire study
- •Willing to use only assigned products for oral hygiene throughout the duration of the study
- •Must give written informed consent
- •Must be in good general health
- •No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Exclusion Criteria
- •Advanced periodontal disease
- •Medical condition which requires premedication prior to dental visits/procedures
- •Not enough teeth to secure the oral retainer
- •Diseases of the soft or hard oral tissues
- •Wear an Orthodontic appliances
- •Impaired salivary function
- •Current use drugs that can affect salivary flow
- •Use antibiotics one (1) month prior to or during this study
- •Pregnant or breastfeeding
- •Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period
- •Use tobacco products
- •Allergic to common toothpaste ingredients
- •Allergic to amino acids
- •Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)
Arms & Interventions
Fluoride free, silica based toothpaste
Control toothpaste containing no anti-cavity ingredients
Intervention: Control toothpaste containing no anti-cavity ingredients (Drug)
Fluoride free, silica based toothpaste
Control toothpaste containing no anti-cavity ingredients
Intervention: Experimental toothpaste containing fluoride and amino acid (arginine) (Drug)
Fluoride free, silica based toothpaste
Control toothpaste containing no anti-cavity ingredients
Intervention: Fluoride toothpaste containing fluoride as the anti-cavity ingredient (Drug)
fluoride + amino acid in a silica toothpaste
Experimental toothpaste containing fluoride and amino acid (arginine)
Intervention: Control toothpaste containing no anti-cavity ingredients (Drug)
fluoride + amino acid in a silica toothpaste
Experimental toothpaste containing fluoride and amino acid (arginine)
Intervention: Experimental toothpaste containing fluoride and amino acid (arginine) (Drug)
fluoride + amino acid in a silica toothpaste
Experimental toothpaste containing fluoride and amino acid (arginine)
Intervention: Fluoride toothpaste containing fluoride as the anti-cavity ingredient (Drug)
1450 ppm fluoride in a silica base toothpaste
Fluoride toothpaste containing fluoride as the anti-cavity ingredient
Intervention: Control toothpaste containing no anti-cavity ingredients (Drug)
1450 ppm fluoride in a silica base toothpaste
Fluoride toothpaste containing fluoride as the anti-cavity ingredient
Intervention: Experimental toothpaste containing fluoride and amino acid (arginine) (Drug)
1450 ppm fluoride in a silica base toothpaste
Fluoride toothpaste containing fluoride as the anti-cavity ingredient
Intervention: Fluoride toothpaste containing fluoride as the anti-cavity ingredient (Drug)
Outcomes
Primary Outcomes
Mineral Change (delta Z)
Time Frame: 2 weeks (from Baseline)
Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of wearing the study retainer, samples from the retainer will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm). These post use values will be compared to the Baseline values to give a delta mineral change (∆ Z).
Secondary Outcomes
No secondary outcomes reported