Experimental design
carious lesion, orthodontic
PERIODONTAL DISEASE
The present in situ study was performed in a block design (volunteers) in which
each participant used two removable intraoral devices containing bovine enamel
fragments (Each device with four fragments). The sample size was determined
using a previous study Eighteen individuals from the community of Ribeirão Preto Dentistry School,
University of São Paulo, Brazil, were evaluated for eligibility. The exclusion
criteria were the use of illicit drugs, presence of an active carious lesion,
periodontal disease, or orthodontic appliance to avoid any interference with the
fit of the device or with the salivary flow. One of them had orthodontic braces
and two declined to participate, hence they were excluded. Thus, fifteen
participants were included in the clinical trial after approval from the
Institutional Review Board (CAAE: 79927217.0.0000.5419/ REBEC - RBR-7p87yr). The
participants were healthy adults between 20 and 35 years of age (average age
25,93±3,34 years) and presented unstimulated salivary flow ≥ 1.5 ml for 5
minutes with pH = 7 The study variables were color alteration, gloss, surface roughness, and
microhardness.