Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study was stopped due to business reasons.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride free, silica based toothpaste | Placebo Comparator | Control toothpaste containing no anti-cavity ingredients |
|
| fluoride + amino acid in a silica toothpaste | Experimental | Experimental toothpaste containing fluoride and amino acid (arginine) |
|
| 1450 ppm fluoride in a silica base toothpaste | Active Comparator | Fluoride toothpaste containing fluoride as the anti-cavity ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control toothpaste containing no anti-cavity ingredients | Drug | 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 for 1 minute before rinsing with water. |
| Measure | Description | Time Frame |
|---|---|---|
| Mineral Change (delta Z) | 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 (∆ Z). | Baseline |
| Mineral Change (delta Z) | 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). | 2 weeks (from Baseline) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bennet Amaechi, PhD, DDS | University of Texas | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Experimental toothpaste containing fluoride and amino acid (arginine) | Drug | 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 for 1 minute before rinsing with water. |
|
|
| Fluoride toothpaste containing fluoride as the anti-cavity ingredient | Drug | 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 for 1 minute before rinsing with water. |
|
|
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D001120 | Arginine |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D024361 | Amino Acids, Basic |
| D000599 | Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |
Not provided
Not provided