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12.e2
Table I.
Demographic characteristics
Age (y)
Sex (%)
Girls
Boys
Clinical characteristics
Crowding (irregularity index, mm)
Angle class (%)
I
II
III
Total (n 5 70)
mean or %
SD
Damon MX (n 5 35)
mean or %
SD
In-Ovation R (n 5 35)
mean or %
SD
P value*
13.8
1.8
13.8
1.8
13.8
1.7
NS
58.6
41.4
7.5
60.0
40.0
2.1
48.6
47.1
4.3
8.0
57.0
43.0
2.1
51.4
42.9
5.7
7.0
45.7
51.4
2.9
NS
2.0
NS
NS
maxillary anterior teeth (canine to canine) between passive and active self-ligating brackets.
MATERIAL AND METHODS
appliance. Randomization was accomplished by generating random permuted blocks of variable size; this
ensured equal patient distribution between the 2 trial
arms. Numbered, opaque, sealed envelopes were prepared before the trial containing the treatment allocation
card. After patient selection, the secretary of the practice was responsible for opening the next envelope in
sequence.
Based on previous research, it was assumed that
a hazard ratio larger than 2 between the bracket groups
would be an important clinical finding.6 Sample size
was calculated. Based on this assumption, the required
sample size was calculated at 66 (a 5 0.05, power 5
80%), and it was decided to include 70 subjects in
case of any losses.
The date (T1) that each patient was bonded was recorded. All patients were followed monthly. Complete alleviation of crowding was judged clinically by the first
author. On visual inspection of correction of proximal
contacts, the patient was considered complete, and the
alignment date (T2) was determined and recorded on
the spreadsheet. Only the alignment of the 6 maxillary anterior teeth was evaluated. In other words, we considered
that a patient had reached the T2 stage if the 6 maxillary
anterior teeth were aligned, regardless of possible irregularities in posterior segments. The time to alignment (T2
T1) for each patient was calculated in days. Blinding of
outcome assessment was not feasible for this study. To assess the reliability of the method, the irregularity index
was remeasured a month later in 20 models, selected randomly, and good agreement was found between the first
and the second measurement (ICC .0.95).
Statistical analysis
Demographic and clinical characteristics were investigated with conventional descriptive statistics.
12.e3
Excluded:
(n= 78)
Enrollment
Randomization
Allocation
Discontinued intervention
(n= 2)
Poor compliance
Follow-Up
Discontinued intervention
(n= 2)
Poor compliance
Analyzed
(n= 33)
Per protocol
Analysis
Analyzed
(n= 33)
Per protocol
these factors between the 2 groups, validating the random assignment of appliances to each group. Four patients were excluded from the statistical analysis
because of poor compliance, and the statistical analysis
was conducted per protocol, since loss to follow-up was
not associated with type of treatment.
In Table II, the results of the treatment time to alignment are shown for the 2 bracket groups; no statistical
significance was found.
The results of the Cox proportional-hazards model
are given in Table III. The In-Ovation R appliance had
a 1.4 hazard ratio over the Damon MX bracket; this implied that the former had a 1.4 times higher probability
of alleviating crowding earlier than the latter, but this
effect did not reach statistical significance. On the contrary, higher irregularity index values were associated
with increased probability of delayed resolving of
crowding (P \0.05).
12.e4
Table II.
Wire system
Damon MX
In-Ovation R
Total
Total
Minimum (d)
Median (d)
Maximum (d)
P value*
33
33
66
107.1
95.0
101.0
56
54
54
99
92
95.5
175
161
175
NS
Predictor
Bracket system
Damon MX
In-Ovation R
Crowding
Irregularity index (mm)
95% CI
P value
Baseline
1.46
0.85-2.51
NS
0.73
0.64-0.84
\0.05
1.00
0.25
The results of this study emphasize the clinical irrelevance of the typical in-vitro assessment of friction protocols in many studies during the past decade. A number
of factors related to the oversimplicity of experimental
configurations and the overwhelming number of assumptions in the experimental design have deprived
ex-vivo friction assessment of clinical relevance and
scientific soundness. These briefly include the rate of
wire sliding onto slot walls, application of forces on
wire, lack of intraoral aging of materials, and study of
variables with little or no relevance to the actual clinical
situation.13-19 A recent critical review of this topic clarified several misconceptions of the study of static and
kinetic friction and their clinical applicability, suggesting that the importance of this parameter has been overestimated in relevant research.20
Small differences in the torque prescriptions between the 2 brackets were not expected to influence
the outcome because these were outweighed by the
large free play that was more than 2 times higher than
the torque differences in a conventional bracket.21
Registration of the irregularity index changes in this
study was performed at the end of treatment because the
rate of correction was unknown; therefore, changes registered at a certain time during therapy might not hold
for the entire treatment. The use of monthly monitoring
0.00
DISCUSSION
0.50
0.75
50
100
analysis time
bracket = Damon
150
200
bracket = In-Ovation R
The results of this RCT suggest that active and passive self-ligating brackets have no difference in treatment duration in the correction of maxillary anterior
crowding, in contrast to the extent of crowding, which
had an effect on the duration of treatment.
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12.e6
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