Dental Caries
Conditions
Brief summary
This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.
Interventions
Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait 1 minute before rinsing with water.
DRUG1.1% Fluoride toothpaste
Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait 1 minute before rinsing with water.
DRUG0.243% Fluoride toothpaste
Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait 1 minute before rinsing with water.
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and/or female subjects 18 to 50 years inclusive 2. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present 3. Willing to wear retainer 24 hours per day 4. No active, unrestored cavities 5. 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 6. Available throughout entire study 7. Willing to use only assigned products for oral hygiene throughout the duration of the study 8. Must give written informed consent 9. Must be in good general health 10. 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
1. Advanced periodontal disease 2. Medical condition which requires premedication prior to dental visits/procedures 3. Not enough teeth to secure the oral retainer 4. Diseases of the soft or hard oral tissues 5. Wear an Orthodontic retainer(s) 6. Impaired salivary function 7. Current use drugs that can affect salivary flow 8. Use antibiotics one (1) month prior to or during this study 9. Positive urine test for pregnancy (a urine pregnancy test will be performed on female subjects of child-bearing potential) 10. Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period 11. Use tobacco products 12. Allergic history to common toothpaste ingredients 13. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as determined by review of medical history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mineral Change (delta Z) | Baseline | Tooth samples of human enamel are placed in a retainer and worn by each study subject. Enamel block samples will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions, vol % µm) before being placed in the retainer. These baseline values will be compared with the post use delta mineral change ( ΔZ). |
Outcome results
None listed