European Journal of Orthodontics, 2017, 453–461

doi:10.1093/ejo/cjx024
Advance Access publication 19 April 2017

Randomized controlled trial

Acceptability comparison between Hawley

retainers and vacuum-formed retainers in
orthodontic adult patients: a single-centre,
randomized controlled trial

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Mohammed Saleh1,4, Mohammad Y. Hajeer2 and Dieter Muessig3
Private Practice and Orthodontic Department, Saudi Swiss Dental Consultant Centre, Al-Khobar, Saudi Arabia,
1

Department of Orthodontics, University of Damascus Dental School, Syria, and 3Centre for Orthodontics, Faculty of
2

Dental Medicine, Danube Private University, Krems, Austria.

Present address: Private Practice and Orthodontic Department, KJMC, Al-Ain City, United Arab Emirates.
4

Correspondence to: Mohammad Y.  Hajeer, Department of Orthodontics, University of Damascus Dental School, Mazzeh
Autostrad, Mazzeh, Damascus, Syria. E-mail: myhajeer@gmail.com

Summary
Background:  Hawley retainers (HRs) and vacuum formed retainers (VFRs) are the most commonly
used removable retainers in the orthodontic practice. Patients’ cooperation in wearing these
appliances is affected by the levels of discomfort and oral impairment. The evidence regarding
their acceptably among orthodontic patients is limited.
Aims:  To compare the acceptability of HRs and VFRs over a 6-month period in a group of fixed
orthodontic patients.
Trial Design:  Two-arm parallel-group randomized controlled trial.
Methods:  Patients being treated at the Orthodontic Department of Saudi Swiss Consultant Dental Centre,
Al-Khobar, Saudi Arabia, who met the inclusion criteria were invited to participate. Inclusion criteria
were treatment only with fixed appliances, no lateral expansion treatment, no hypodontia, no cleft lip
and palate, no surgical corrections, no extraction-based plans, 18 years old or greater, and willingness
to wear maxillary and mandibular removable retainers. Participants were distributed randomly using
concealed envelopes into two groups: HR group and VFR group. A pilot-tested questionnaire was filled
at three times: 1 week after fitting of the retainer (T1), 3 months and 6 months following appliance
fitting (T2 and T3, respectively). Ten questions were given on biting, fitting of the appliance, speech,
appearance, oral hygiene, durability, gingival irritation, swallowing, self-confidence,  and comfort.
Responses were given on a visual analogue scale. Blinding was employed during data analysis.
Results:  Ninety-four patients were included primarily. Six patients in the Hawley group and two
patients in the VFR group failed to complete the study.Therefore, 86 patients were included the analysis
(HR group: 41; VFR group: 45). No significant differences were found between the two groups in biting,
fitting of the appliance, and hygiene perception, whereas significant differences were detected in
speech (P < 0.05), appearance (P < 0.001), gingival irritation (P < 0.001), durability (P < 0.001), swallowing
(P < 0.001), self-confidence, and comfort (P < 0.001). No harm to any patient was noticed during the trial.
Conclusions:  Over a 6-month period of retention, VFR was significantly more acceptable than HR in
speech, appearance, gingival irritation, swallowing, self-confidence, and comfort. Subjects in the HR
group believed that their retainers were significantly more durable than those in theVFR group at the final
assessment. Both retainers were equal regarding fitting of the appliance, biting, and hygiene perception.

© The Author 2017. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved.
453
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454 European Journal of Orthodontics, 2017, Vol. 39, No. 4

Registration:  Not registered.

Protocol:  The protocol was not published before trial commencement.
Funding:  This trial was funded by the Saudi Swiss Consultant Dental Centre.

Introduction from October 2012 to June 2014. The study was approved by the
Local Research and Ethics Committee at the Healthcare ­institution
Many types of removable retainers have been used after active ortho-
(Ethical Approval number E528). All subjects included in this trial
dontic treatments to maintain teeth in the final functional and aesthetic
were treated by one orthodontist (MS). All patients who have fin-
position (1). Hawley retainers (HRs) and vacuum-formed retainers
ished their treatment with fixed orthodontic appliance in the ortho-
(VFRs) are the most commonly prescribed removable retainers in the
dontic clinic of the first author (MS) during study period were
orthodontic practice (2). Many studies have been performed to evalu-
assessed and informed about the research project. An information
ate the effectiveness of HRs versus VFRs. Most studies have shown
sheet was given to each patient. From the screened 153 patients,
no significant difference between both appliances regarding quality of

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only 94 patients fulfilled the inclusion criteria (i.e. 51 females and
retention (3–5) except for lateral expansion cases in which HRs are rec-
43 males). The inclusion criteria were as follows: treated only with
ommended (6) or maxillary/mandibular labial segments’ corrections of
fixed appliance in both arches, no application of lateral expansion
crowding in which VFRs are recommended (7,8). The most disadvan-
treatments, no cleft lip and palate, no missing teeth, non-extraction-
tage of using removable retainers is the need of patient’s compliance
based plans, not treated with orthognathic surgery, 18 years old or
(9). From reviewing the literature, it can be concluded that discomfort
greater, and willingness to wear maxillary and mandibular remov-
caused by orthodontic appliance wear has a negative influence on the
able retainers. The other 59 patients were not eligible for the follow-
appliance acceptance and on patient’s compliance (10). These discom-
ing reasons: 5 used removable appliances during their orthodontic
forts are mainly difficulty in speaking (11), extra salivation, and embar-
treatment, 7 had lateral expansion, 1 patient had cleft lip and palate,
rassment (12). Several studies have highlighted a nearly universal dislike
3 patients had hypodontia, 4 patients were treated with orthognathic
of orthodontic retainers. Some patients describe them as being more
surgery, 26 were treated with extraction, 11 patients were less than
inconvenient than their fixed appliances (11–13) and even headgear
(13). It is very important for the orthodontist to choose the removable
retainer type that provides good retention with high level of accept-
ability; this might contribute to better stability of the results on the long
run. Reviewing the literature reveals that there are only two studies in
which an objective comparison of patients’ acceptance was conducted
between HRs and VFRs. The main aim of the first prospective study was
to evaluate cost-effectiveness and patient satisfaction for both HRs and
VFRs (14). However, this study did not evaluate patients’ acceptability
in detail. The second study was a retrospective study and was conducted
to assess the compliance with HRS and VFRs in the post-retention phase
by mailing questionnaires to patients who had finished fixed appliance
therapy within the past 6 years (15). A recently published systematic
review on HRs and VFRs concluded that additional high-quality ran-
domized controlled trials were required to determine the best retainer
for use in the orthodontic daily practice (2). The same conclusion was
also given in a recent Cochrane’s review of retention procedures (16).

Specific objective and hypothesis

The aim of the current randomized controlled trial was to compare
the levels of acceptability for the two types of removable retainers (i.e.
HRs and VFRs) over a 6-month period of follow-up. Null hypothesis
was as follows: there are no statistically significant differences in the
acceptability levels of HR and VFR over a 6-month period.

Methods
Trial design
This trial was designed as a prospective parallel-group randomized
controlled trial with a 1:1 allocation ration. No changes to the meth-
ods after trial commencement occurred.

Participants, eligibility criteria, and setting

This prospective study was conducted in the Department of
Orthodontics and Dentofacial Orthopaedics, Saudi Swiss
Consultant Dental Centre located in Al Khobar City, Saudi Arabia, Figure 1.  Participants’ flow diagram.
M. Saleh et al.
18 years old at the time of debonding, and 2 patients had only one
arch treatment.
Participants’ recruitment and flow
Patient recruitment commenced in October 2012 and ended in January
2014. The follow-up period started in October 2012 and ended June
2014. A CONSORT flow diagram of participants’ recruitment, follow-
up, and entry into data analysis is given in Figure  1. Six patients in
the Hawley group failed to complete the study (two patients moved
to another country and four patients did not fill the questionnaires).
On the other hand, two patients in the VFR group failed to complete
the study (one patient moved to another country and one patient
did not fill the questionnaire). These eight patients were excluded
from the analysis.
Interventions
Written informed consents were obtained. Random allocation was
performed, and patients were assigned to receive either a HR or a
VFR. Each group had 47 subjects initially. Two fully qualified labo-
ratory technicians fabricated the retainers to standardized designs.
For patients in HR group, upper and lower HRs were con-
structed with acrylic baseplates and labial bows made of 0.7-mm
stainless steel wire. The labial bows had U loops and crossed the
occlusal plane distal to the canines. Two Adams clasps were placed
on the first molars for retention (Figure 2). All wires crossing occlusal
embrasures into lingual acrylic were closely adapted to eliminate
possible interference with opposing teeth.
For patients in VFR group, upper and lower VFRs were formed
using 1-mm-thick polycarbonate sheets (Erkodur; Erkodent,
Pfalzgrafenweiler, Germany) using a Biostar machine (Scheu-Dental,
Iserlohn, Germany) and trimmed to provide 2-mm buccal and 3- to
4-mm lingual extensions. The VFR retainer covered the occlusal sur-
faces up to and including the most distal molars (Figure 3).
All retainers were fitted on the same day of debonding. The sub-
jects were instructed to wear both retainers 24  h/day for the first
6 months and 12 h/day (nighttime wear) for the next 6 months. They
were asked to remove their retainers only while eating, drinking
(except water), or cleaning. Lower fixed lingual retainers, extending
Figure 2.  Hawley retainer used in the study.
455
from canine to canine, made from 17.5 mil three-stranded stainless
steel twisted wire were bonded in all subjects. Written and verbal
instructions were given to each patient. In case of breaking or losing
the retainer, the patient was asked to come immediately to the office
and make a new one. Compliance levels were good for all patients.
‘Compliance charts’ were used to assess this aspect as suggested by
previous reports (17).
Outcomes (primary and secondary) and any
changes after trial commencement
Patients’ acceptance was evaluated using a 10-cm visual analogue
scale (VAS) (18), which contained 10 questions on teeth biting (clos-
ing teeth with retainers, not chewing food), fitting of the appliance,
speech, appearance, oral hygiene, durability, gingival irritation, swal-
lowing, self-confidence, and comfort (Appendix 1).
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Patients were given oral and written instructions and explana-
tions on how to complete these questionnaires. The lowest (least
favourable) score was ‘0’ and the highest (most favourable) score
was ‘10’ For example, if the retainer was very uncomfortable, it was
scored as ‘0’ and if it was very comfortable, it was scored as ‘10’.
Questionnaires were filled in front of the treating doctor at their
normal follow-up visits, and these were at the following assessment
times: 1 week after retainers’ fitting (T1), 3 months after retainers’
fitting (T2) and after 6 months of retainers’ fitting (T3).
Data collection was performed by the principal researcher (MS)
using the same digital calliper (Mitutoyo, Kawasaki, Japan), the same
table, and light source for all questionnaires. Patients’ questionnaires
were analysed using Statistical Package for Social Sciences, version
commencement
21.0 (SPSS Inc., Chicago, Illinois, USA). = permulaan
A pilot study was performed for the questionnaire before the
commencement of the main study to detect any difficulty in under-
standing its contents, to detect any additional complaints that could
have arisen by the retainers’ wear, and to measure the standard devia-
tion (SD) for the variable ‘comfort’ to allow for sample size calcula-
tion. The pilot study sample consisted of 10 patients (5 males and 5
females) treated by only fixed preadjusted appliance with a mean age
of 23.33 ± 4.75 years and were asked to fill in the questionnaire at 1
week and 1 month following retainers fitting (five patients with HRs
and five with VFRs). The pilot study revealed that there was no need
for any modification.
Figure 3.  Vacuum-formed retainer used in the study.
456 European Journal of Orthodontics, 2017, Vol. 39, No. 4

To detect error of the method, 20 questionnaires were selected Error of the method

randomly (10 from the HR and 10 from the VFR group). These
questionnaires were randomly selected 2  months after the first
assessment and re-measured by the same principal researcher. The
error of the method was determined by employing paired t-tests
to detect systematic error and intraclass  correlation coefficients
(ICCs) to assess intra-observer reliability (or random error). No
change in the evaluated outcome variables occurred following study
commencement.
Sample size calculation
It was postulated that the smallest difference requiring detection
for the variable ‘comfort’ was 0.5  cm on the VAS. When the sig-
nificance level of two-sided tests was set at 0.05 and the statistical
power at 80 per cent taking into account that the standard devia-
Mean differences between repeated measurements ranged from 0.09
to 0.34 mm with no systematic error for variables (Table 2). ICCs
were high among all assessed measurements and ranged from 96.7
to 99.3 per cent.
Acceptability results for the HRs and VFRs
Descriptive statistics of the studied variables at three assessment
times are given in Table 3 and with P-values of significance tests in
Supplementary Table 1.
At 1 week following appliance insertion (T1), there were signifi-
cant differences between the two groups in all variables except for
biting, fitting of the appliance, and durability (P = 0.462, 0.383 and
0.583, respectively). Higher significant levels of acceptance were
found in the VFR group. At 3 months following appliance insertion

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tion from a pilot study was found to be 0.78 cm for this variable,
a sample size of 40 patients was required for each group (19). We
decided to enrol 47 patients per group to compensate for any pos-
sible dropouts.
Interim analyses and stopping guidelines
No interim analyses were applied, and no stopping guidelines were
employed in this trial.
Randomization and allocation concealment
The randomization procedure was performed manually. One of the
authors (MS) asked each participant to pick up a concealed opaque
envelope from a black plastic box. This box contained 94 envelopes
with 47 containing the letter H (i.e. HR) and the other 47 contain-
ing the letter V (i.e. VFR). This manual allocation was recorded by
a dentist not involved in this research and was concealed from the
principal researcher (MS) until the onset of the project. No stratifica-
tion was made with regard to gender.
(T2), there were significant differences between the two groups in
all variables except for biting, fitting of the appliance, and durabil-
ity (P  =  0.182, 0.554 and 0.981, respectively). Higher significant
levels of acceptance were found in the VFR group. At 6  months
of follow-up (T3), there were significant differences between the
two groups in all variables except for biting, fitting of the appli-
ance, and hygiene (P  =  0. 0.095, 0.943 and 0.088, respectively).
Higher significant levels of acceptance were detected in the VFR
group except for durability, which was significantly higher in the
HR group (P < 0.001).
Changes in patients’ perceptions towards the 10 assessed vari-
ables over time are given in Tables 4 and 5 for the Hawley and
VFR groups, respectively. In the Hawley group, a gradual increase
in the acceptance levels was noticed during the follow-up period
(Table  4), whereas in the VFR group, a similar gradual increase
in the acceptance levels was observed except for the ‘durabil-
ity of the retainer’ variable which decreased significantly at T3
(Table 5).

Blinding Table 1.  Age and sex characteristics of the current sample.

Blindness was applied during data analysis as the principal researcher HR group VFR group Both groups
was not aware of the group to which the patient belonged or the Variable (n = 841) (n = 45) (n = 86)
administration time of the questionnaire under analysis. Laboratory
technicians fabricated the retainers were blind to the fact that they Age (mean ± SD) 25.97 ± 6.21 26.66 ± 5.95 26.31 ± 6.08
were making retainers for patients included in this trial. Sex: n (%)
 Male 18 (44%) 19 (42%) 37 (43%)
 Female 23 (56%) 26 (58%) 49 (57%)
Statistical analysis
Descriptive and inferential statistics were performed using both
Statistical Package for the Social Sciences version 21.0 software Table 2.  Systematic and random error in the measurements made
(SPSS Inc., Chicago, Illinois, USA) and Minitab® V16 (Minitab Inc., on the questionnaires (n = 20).
Pennsylvania, PA, USA). Mean difference
Anderson–Darling normality tests were used to check the distri- Variable (in mm) P-value* ICC**
bution of data (20). Chi-square tests were used to detect significant
differences between the two group regarding gender. Two-sample Biting 0.16 0.127 0.985
t-tests were used to detect significant differences between the two Fitting 0.33 0.445 0.967
groups at each assessment time. Repeated-measures analysis of var- Speech 0.23 0.432 0.992
Appearance 0.18 0.711 0.987
iance was used to detect significant differences between the three
Hygiene 0.09 0.933 0.992
assessment times in each group. Post hoc tests for pairwise com-
Durability 0.31 0.443 0.993
parisons were also performed. Significance level was set at 0.05. Gingival irritation 0.20 0.134 0.984
Swallowing 0.34 0.332 0.988
Results Self-confidence 0.29 0.399 0.975
Comfort 0.19 0.511 0.991
Baseline data
The baseline characteristics of the patients in each group who com- *Applying paired t-tests to detect significant differences.
pleted the questionnaires are shown in the Table 1. **Intraclass correlation coefficients.

tidak ada perbedaan signifikan

 M. Saleh et al.

Table 3.  Descriptive Statistics of the assessed variables at three times with the estimates of the differences between the two groups at each assessment time in conjunction with the 95% con-
fidence intervals of the differences. CI, confidence interval.

One-week follow-up* Three-month follow-up Six-month follow-up

Variable Device Mean Mean difference 95% CI of the difference Mean Mean difference 95% CI of the difference Mean Mean difference 95% CI of the difference

Biting HR 4.96 −0.24 −0.890; 0.406 6.28 0.36 −0.177; 0.906 7.18 0.91 0.427; 1.387
VFR 5.22 5.92 6.27
Fitting HR 6.38 −0.26 −0.856; 0.332 6.82 −0.15 −0.684; 0.367 7.08 0.02 −0.451; 0.483
VFR 6.64 6.98 7.06
Speech HR 3.96 −1.51 −2.113; −0.899 6.17 −1.29 −1.789; −0.802 7.41 −1.26 −1.707; −0.803
VFR 5.46 7.47 8.66
Appearance HR 4.63 −2.91 −3.494; −2.322 5.39 −1.55 −3.86; 0.76 5.84 −2.77 −3.246; −2.298
VFR 7.54 8.06 8.61
Hygiene HR 5.93 −1.17 −1.791; −0.555 6.85 −0.75 −1.254; −0.248 7.56 −0.41 −0.897; 0.064
VFR 7.10 7.6 7.98
Durability HR 6.47 −0.17 −0.768; 0.433 7.38 0.00 −0.485; 0.477 8.12 1.82 1.052; 2.595
VFR 6.63 7.38 6.29
Gingival irritation HR 5.50 −1.56 −2.263; −0.861 6.81 −1.49 −2.011; −0.965 7.71 −1.28 −1.741; −0.822
VFR 7.06 8.30 8.99
Swallowing HR 4.48 −1.96 −2.581; −1.342 6.41 −1.34 −1.788; −0.886 7.61 −1.28 −1.685; −0.878
VFR 6.44 7.74 8.89
Self-confidence HR 5.18 −2.45 −3.024; −1.881 6.32 −2.07 −2.536; −1.597 6.93 −2.18 −2.559; −1.796
VFR 7.64 8.39 9.11
Comfort HR 5.28 −2.21 −2.661; −1.755 6.49 −1.92 −2.304; −1.542 7.18 −1.86 −2.200; −1.524
VFR 7.49 8.41 9.04

Two-sample t-tests were applied and those 95% CIs accompanied with significant differences are shown in italics.
*Values are given here in centimetres. CI = besar CI menentukan p value, di tabel 3 95%, p valuenya 5% atau 0.05, p> 0.05 -> tidak ada perbedaan bermakna
457

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458 European Journal of Orthodontics, 2017, Vol. 39, No. 4

Table 4.  Descriptive statistics of changes observed between the three assessment times in the Hawley group as well as P values of repeat-
ed-measures ANOVA tests and post hoc pairwise comparisons. ANOVA, analysis of variance.

Difference T2 − T1 Difference T3 − T1 Difference T3 − T2

Variable P-value* Mean SD P-value** Mean SD P-value** Mean SD P-value**

Biting <0.001 1.33 0.99 <0.001 2.20 1.07 <0.001 0.89 0.61 <0.001
Fitting <0.001 0.44 0.82 <0.001 0.70 1.29 <0.001 0.25 0.98 0.104 tidak bermakna
Speech <0.001 2.22 1.01 <0.001 3.42 1.12 <0.001 1.23 0.68 <0.001
Appearance <0.001 0.76 0.95 <0.001 1.21 1.01 <0.001 0.45 0.87 <0.01
Hygiene <0.001 0.92 0.88 <0.001 1.64 1.14 <0.001 0.71 0.85 <0.001
Durability <0.001 0.92 1.00 <0.001 1.65 1.14 <0.001 0.74 0.55 <0.001
Gingival irritation <0.001 1.31 1.25 <0.001 2.21 1.50 <0.001 0.90 0.80 <0.001
Swallowing <0.001 1.92 0.89 <0.001 3.12 1.01 <0.001 1.20 0.77 <0.001
Self-confidence <0.001 1.14 0.59 <0.001 1.75 0.73 <0.001 0.60 0.52 <0.001
Comfort <0.001 1.21 0.70 <0.001 1.90 0.82 <0.001 0.69 0.52 <0.001

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*P-values from repeated-measures ANOVA test. **P-values from post hoc pairwise comparison tests (Bonferroni tests), level of significance set at 0.05. Signifi-
cant P-values were italics.

Table 5.  Descriptive statistics of changes observed between the three assessment times in the VFR group as well as P-values of repeated-
measures ANOVA tests and post hoc pairwise comparisons. ANOVA, analysis of variance.

Difference T2 − T1 Difference T3 − T1 Difference T3 − T2

Variable P-value* Mean SD P-value** Mean SD P-value** Mean SD P-value**

Biting <0.001 0.69 0.65 <0.001 1.05 0.89 <0.001 0.35 0.68 <0.01
Fitting <0.01 0.34 0.93 <0.05 0.42 0.94 <0.01 0.08 0.78 0.499
Speech <0.001 2.00 0.98 <0.001 3.19 1.13 <0.001 1.19 0.50 <0.001
Appearance <0.001 0.52 0.60 <0.001 1.06 0.96 <0.001 0.54 0.58 <0.001
Hygiene <0.001 0.5 0.87 <0.001 0.88 1.13 <0.001 0.37 0.71 <0.01
Durability <0.01 0.75 0.87 <0.001 −0.34 2.43 0.355 −1.09 2.18 <0.001
Gingival irritation <0.001 1.23 0.97 <0.001 1.93 1.24 <0.001 0.69 0.59 <0.001
Swallowing <0.001 1.3 0.88 <0.001 2.44 1.15 <0.001 1.14 0.70 <0.001
Self-confidence <0.001 0.75 0.48 <0.001 1.47 0.92 <0.001 0.71 0.60 <0.001
Comfort <0.001 0.92 0.56 <0.001 1.54 0.78 <0.001 0.62 0.49 <0.001

*P-values from repeated-measures ANOVA test. **P-values from post hoc pairwise comparison tests (Bonferroni tests), level of significance set at 0.05. Signifi-
cant P-values were italics.

Harms
No harms or severe untoward effects were observed during the trial.
Discussion
Main findings in the context of the existing
evidence
This prospective randomized controlled trial was conducted to com-
pare the acceptability of HRs and VFRs in a sample of subjects have
finished their treatment with the fixed orthodontic appliance. The
assessment of patient satisfaction and acceptance following different
treatment protocols, in the form of questionnaires, is increasingly
being used in research and audits (21). The acceptability of both
retainers was evaluated using a 10-cm VAS with 10 items. Its validity
and reliability were proven in previous papers (18).
In such studies, patients’ withdrawals are highly expected, so
more patients were invited and included in the study to overcome
this sample attrition. The attrition rate of 8.5 per cent in the cur-
rent study may have biased the results slightly, but some authors
believe that this loss-to-follow-up rate had little effects on the results
and ‘bias’ should be considered ‘high’ when this rate exceeds the 10
per cent limit (22). We excluded patients that had lateral expansion
in the course of their treatment because it has been suggested that
VFRs are not as good as HRs in maintaining arch width changes
(6). At the same time, lower fixed lingual retainers, extending from
canine to canine, were bonded in all patients because some investi-
gations have shown that VFRs are better than HRs in maintaining
corrections of the maxillary and mandibular labial segments (7, 8).
It was expected that patients who used removable appliances during
their active orthodontic phase (as an adjunctive appliance or as a
first-phase treatment) might be adapted in some way to these appli-
ances; this is why these patients were not included in our sample.
Patients with hypodontia, with cleft lip and palate, or who under-
went orthognathic surgery were excluded because they might have
special consideration of retention protocols. The current study was
designed in a way to achieve optimum response rate since patients
were required to fill in the questionnaires within the office at their
post-treatment regular check-ups. This has been shown to improve
response rate than sending these questionnaires by mail (23).
Results from this study showed several statistically significant
differences in the levels of acceptance between the HR and the VFR
groups at the three assessment times. After 1 week, the significant
higher levels of speech ability and swallowing ability with the VFRs
could be a result of the minimal palatal coverage compared to that
of HRs. This might cause fewer disturbances to the tongue when
speaking and swallowing. The significant higher acceptance levels of
M. Saleh et al.
appearance in the VFR group can be explained by the clear material of
the VFR and the less visibility compared to the visible metallic labial
bow of the HR. The significant higher levels of perception of good
hygiene with the VFR group can be a result of the apparently higher
levels of visibility of food remnants beneath the appliances compared
to the HRs. The significant less levels of gingival irritation with the
VFRs can be attributed to the absence of retentive metal elements such
as Adams clasps and the labial bow. The significant higher levels of
self-confidence with the VFR may be related to its clear appearance
with less visibility and higher ability to talk when the retainer is in
situ. The significant higher levels of comfort with the VFR may be due
to the higher levels of appearance acceptance, oral hygiene perception,
swallowing ability, talking ability, and self-confidence with significant
less level of gingival irritation. The lighter weight of VFR may be an
additional reason although it was not measured in the current study.
At 6  months of retention, only two variables changed in com-
parison with the baseline data at 1 week of retention. No significant
difference was assessed at T3 regarding ‘oral hygiene perception’
between the HR group and the VFR group (P = 0.088). This may
be attributed to the continuous and persistent hygiene instructions
given to all patients after 1 week and till 3 months of appliance wear.
The significant higher perception of durability with the HRs at
the last assessment time could be explained by the increased inci-
dence of VFR breakages and fractures that were recorded between 3
and 6 months of retention. The higher frequency of VFR breakages
could be explained by their flexibility and their occlusal coverage of
teeth making them prone to fracture under occlusal forces.
A critical evaluation of the literature review reveals that the
current study can be compared with only three published studies:
Hichens et al. (14), Pratt et al. (15), and Sun et al. (24). The design of
the current study as well as the employed questionnaire was different
so only partial comparisons can be performed.
Based on the results from this study, there were no significant
changes in levels of the responses to all questions between 3 and
6  months after retainers’ fitting except for oral hygiene percep-
tion and appliance durability perception. This agrees partially with
the results of Hichens et al. (14) who found no significant changes
between 3 and 6 months after retainers’ fitting for all of their vari-
ables. However, their study did not assess oral hygiene perception,
and only appliance durability perception was included. The materi-
als used in the current study, time of retainers’ wear, and patients’
care and understanding may all play a role in explaining the differ-
ence between the current study and Hichens’ study.
Not surprisingly, our patients in the VFR group were more
pleased with the appearance of their retainers. The labial wire of
the HRs was visible, and a number of subjects expressed mild dis-
satisfaction. This agrees with the results of Hichens et al. (14). On
the other hand, Pratt et al. found no differences regarding aesthetic
aspects between the VFR and the HR group (15). One explanation
could be the difference in the study design. Our study and Hichens’
study were prospective studies, but the study of Pratt et  al. was a
retrospective study and was based on mailing their questionnaires to
the recruited patients who had finished their orthodontic treatment
6 months to 6 years before the time of questionnaires’ dispatch. In
addition, the follow-up period in the current study is only 6 months,
and this may be another source of difference.
Higher significant levels of self-confidence were assessed in this
study in subjects of VFR group. This is consistent with the findings
of Hichens et al. who found that using HRs caused more embarrass-
ment than using VFRs (14).
459
Patients in this study experienced a significant decrease in appli-
ance durability perception of their VFRs after 6 months of retainers’
wear. This disagrees with results of Hichens et al. (14) who found
that the number of broken HRs was significantly higher than that
of VFRs. In this study, a mild increase in the acrylic thickness at the
anterior segment of lower HRs was requested, and this may explain
the difference between the current findings and those of Hichens
et al. Another explanation may be related to the duration of daily
wear of the appliances since in the current study, patients were asked
to wear their appliances full time, but this was not applicable to the
patients evaluated in Hichens et al. study. On the other hand, there
was no statistically significant difference between the HR group and
VFR group in the survival time over a 1-year follow-up in the study
of Sun et al. (24). The difference between their findings and the cur-
rent findings can be attributed to the difference in study design and
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length of the follow-up period.
Limitations
Although there is no universal agreement concerning retention pro-
tocols for removable appliances, many authors have advised that
these appliances should be worn for at least 1 year after orthodontic
treatment (25–28). All retainers in this study were applied within
the same day of debonding. Patients were asked to wait until these
retainers were fabricated in the dental laboratory, which was a part
of the dental care centre. Filling a questionnaire after 2 hours of
waiting was expected to result in low response rate. Therefore, the
first assessment time that should have been ideally the same day of
appliance insertion was postponed till the next visit at 1 week fol-
lowing appliance insertion.
We planned to include only patients with an age over 18 years
because we thought that obtaining the participation approval
of minors’ parents would be difficult since many of these minors
used to visit the orthodontic care centre without their parents.
Complications that were encountered in this study can be summa-
rized as breakages of retainers (2.4 per cent in the HR group versus
6.6 per cent in the VFR group) and loss of retainers (4 per cent in the
HR group versus 6 per cent the VFR group).
It should be noted that the reliability and validity of any ques-
tionnaire are dependent to a large extent on the correct use of end
phrases (i.e. the end poles on each VAS) as well as the question per se
is consistent with the end phrases. Therefore, there was an apparent
limitation regarding some items used in the current questionnaire
such as ‘gingival irritation’ and ‘durability’, and future research work
should include items with statements that conform to the given end
phrases for each scale in a better way.
Generalizability
The generalizability of these results might be limited because this
research was undertaken in a single centre by one clinician experi-
enced in both appliances, and the protocol of retention in this centre
may not be similar to other protocols in other centres worldwide.
Patients who had been treated by removable appliances were not
included in this trial, and this is another source of our inability to
generalize the results on all patients under orthodontic treatment.
Conclusions
• The VFRs are significantly more acceptable than the HRs regard-
ing speech ability, appearance, gingival irritation, swallowing
460
ability, self-confidence, and comfort over a 6-month period after
their initial fitting.
• No significant differences were observed between the HRs and
VFRs regarding subjects’ perception of oral hygiene, biting, and
fitting of the appliance after a 6-month period following their
first use.
• Subjects in this study considered the HRs to be significantly more
durable than VFRs after a 6-month period following their first
wear.
Supplementary material
Supplementary data are available at European Journal of
Orthodontics online.
Conflict of interest
The authors do not have any conflict of interest to declare.
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Appendix 1
M. Saleh et al.