Can shielded brackets reduce mucosa alteration and increase comfort perception in orthodontic patients in the first 3 days of treatment? A single-blind randomized controlled trial
Volume 148, Issue 6, December 2015, Pages 956–966
Introduction
Orthodontic
patients can experience pain and discomfort on the oral mucosa from
trauma caused by friction with the brackets and the wires. In this
split-mouth design, single-blind randomized controlled trial, we aimed
to investigate whether brackets with a self-snapping customized plastic
shield would induce less mucosa alteration and discomfort than those
without the shield.
Methods
The
overall sample comprised 42 patients (22 female, 20 male) from a
government-funded orthodontic practice, with a mean age of 16.7 years.
Eligibility criteria included, among others, no history of mouth ulcers
or systemic diseases. Customized shields for the maxillary and
mandibular brackets were fabricated and inserted on one side of the
mouth. The null hypothesis was that bracket shielding would have no
advantage. The primary outcomes were mucosal and discomfort assessments.
As the secondary outcome, the numbers of spontaneous detachments of the
shields were reported. Treatment allocation was mainly implemented
using a random number table for selection of the intervention side. Only
the raters in charge of assessing the oral mucosa were blinded to the
side of the mouth where the shields had been placed. The mucosa was
assessed by 3 calibrated raters at the following time points:
immediately before bracket placement (baseline assessment, T0), 3 days
after delivering the shields (direct assessment of intervention, T1),
and 4 days after removal of the shields (indirect assessment of
intervention, T2). The raters used a newly devised yardstick in which
the higher the score, the more severe the alteration. Discomfort was
assessed at T1 and T2 using a visual analog scale. The Mann-Whitney U
test was performed at the 5% level of significance.
Results
Of
60 patients, 42 were eligible, and 35 were randomly selected to have
one side of the mouth receive the intervention. Two patients
discontinued the intervention at T1, and 5 stopped at T2. Seven
additional patients were recruited and completed all time points. Thus,
42 patients participated at T0, 40 at T1, and 35 at T2. Thirty-five
patients participated at all time points. At T1, no statistically
significant difference in terms of mucosa alteration was observed
between the 2 sides (median of all differences [MD], 0.0; 95% CI,
0.0-1.0; P = 0.11). The same occurred at T2 (MD, 0.0; 95% CI, 0.0-0.0; P = 1.00). The comfort level was statistically higher at T1 on the shielded side (MD, 14.0; 95% CI, 1.0-36.0; P = 0.04), whereas no difference was observed at T2 (MD, 0.0; 95% CI, 0.0-1.0, P = 0.81). No serious harm was observed.
Conclusions
The
customized bracket shields were effective in reducing discomfort during
the first 3 days of orthodontic treatment despite no significant
difference in terms of visible mucosa alteration.
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