Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride



Status:Completed
Conditions:Other Indications, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Other
Healthy:No
Age Range:18 - 80
Updated:2/9/2018
Start Date:January 1, 2009
End Date:June 1, 2009

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A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model

This study will evaluate and compare the effect of the amount of toothpaste used and brushing
time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel
fluoride uptake (EFU).


Inclusion Criteria:

General and Dental Health

- Good general and dental health with (in the opinion of the investigator) no clinically
significant and relevant abnormalities of medical history or oral examination

- Have no current active caries or periodontal disease that may compromise the study or
the health of the subjects

- Residency: Currently living in the Indianapolis, Indiana area

Dentures:

- Currently wearing a removable mandibular partial denture with sufficient room in the
posterior buccal flange area to accommodate two enamel specimens (required dimensions
12 mm x 7 mm)

- Willing to have their denture modified to accommodate enamel test specimens and
willing and capable of wearing their removable mandibular partial dentures 24 hours
per day during the experimental periods

- All restorations in a good state of repair

- Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated
whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥
0.8 mL/minute)

Exclusion Criteria:

- Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated
use during the study treatment periods

- Study Scale Use: Subjects unable to measure product weights accurately using the
assigned study scale as determined by the study staff (as demonstrated on or before
Visit 4)

- A member of the site study staff who is directly working on the project or living in
that staff's household

- Any employee of any toothpaste manufacturer or their spouse or family member
We found this trial at
1
site
Indianapolis, Indiana 46202
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mi
from
Indianapolis, IN
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