Dental Caries
Conditions
Brief summary
The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.
Interventions
DRUGToothpaste containing 1150ppm F
US marketed toothpaste containing 1150ppm of F
OTHERToothpaste containing 0ppm F
Experimental toothpaste containing 0ppm F
DRUGToothpaste containing 250ppm F
Experimental toothpaste containing 250ppm F
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Demonstrates understanding of the study. 2. Aged 18 to 85 years. 3. Understands and is willing, able and likely to comply with all study procedures and restrictions. 4. Has good general health (in the opinion of the investigator or medically qualified designee). 5. Currently living in the Indianapolis, Indiana area. 6. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens. 7. Have no current active caries or periodontal disease and all restorations in a good state of repair. 8. Have a salivary flow rate in the range of normal values.
Exclusion criteria
1. Pregnant or breast feeding women. 2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients. 3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit. 4. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated. 5. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. 6. Have received a professional fluoride treatment within 14 days of randomization to the first treatment. 7. Recent history (within the last year) of alcohol or other substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste | 4 weeks | The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments | 4 weeks | The change in mineral content (ΔM) of the lesions as measured by TMR will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ) |
| Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments | 4 weeks | The change in lesion depth (ΔL) as measured by TMR will be calculated by: ΔL= (Post-treatment lesion depth - baseline lesion depth) |
| Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments | 4 weeks | The change in SZmax (ΔSZmax) as measured by TMR will be calculated by: ΔSZmax= (Post-treatment SZmax - baseline SZmax) |
Outcome results
None listed