10 1093@ejo@cjy070
10 1093@ejo@cjy070
10 1093@ejo@cjy070
doi:10.1093/ejo/cjy070
Advance Access publication 13 October 2018
Correspondence to: Farhan Bazargani, Postgraduate Dental Education Center, Department of Orthodontics, P.O. Box 1126,
SE-701 11 Örebro, Sweden and School of Medical Scienses, Faculty of Medicine and Health, Örebro University, Örebro
SE-701 82, Sweden. E-mail: [email protected]
Summary
Background: Closed and open surgical techniques are two different main approaches to surgical
exposure of palatally displaced canines (PDCs). Because there is insufficient evidence to support
one technique over the other, there is a need for randomized controlled trials.
Objectives: To compare surgery time, complications and patients’ perceptions between closed
and open surgical techniques in PDCs.
Trial design: The trial was a multicentre, randomized, controlled trial with two parallel groups
randomly allocated in a 1:1 ratio.
Material and methods: Study participants were 119 consecutive patients from 3 orthodontic
centres, with PDCs planned for surgical exposure, randomly allocated according to a computer-
generated randomization list, using concealed allocation. Full-thickness mucoperiosteal flap was
raised, and bone covering the canine was removed in both interventions. In closed exposure, an
attachment with a chain was bonded to the canine and the flap was sutured back with the chain
penetrating the mucosa. In open exposure, a window of tissue around the tooth was removed
and glass ionomer cement placed on the canine crown, to prevent gingival overgrowth during
spontaneous eruption. Patient perceptions were assessed with two questionnaires, for the evening
on the day of operation and 7 days post-surgery.
Blinding: It was not possible to blind either patients or care providers to the interventions. The
outcome assessors were blinded and were unaware of patients’ intervention group.
Results: Seventy-five girls and 44 boys, mean age 13.4 years (SD 1.46) participated in the study
and got either of the interventions (closed exposure, n = 60; open exposure, n = 59). Surgery time
did not differ significantly between the interventions. Complications though were more severe in
bilateral cases and the patients experienced more pain and impairment in the open group.
© The Author(s) 2018. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved.
626
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M. Björksved et al. 627
Conclusion: There were no statistically significant differences regarding surgery time between the
groups. Postoperative complications were similar between the groups in unilateral PDCs, but more
common in the open group in bilateral cases. More patients in the open group experienced pain
and impairment compared to the closed group.
Trial registration: Trial registration: ClinicalTrials.gov, ID: NCT02186548 and Researchweb.org, ID: 127201.
• Chlorhexidine preparation 0.12% mouth rinse (Paroex®) two 90% with an alpha of 5%, 48 participants per group were required.
times a day post-surgery for 7 to 10 days. If the child has difficul- A presumed dropout rate of 15% (21) resulted in inclusion of 111
ties rinsing, the operation field may be cleaned with Oraclean participants, and another 9 were included to give a total of 120 par-
mouth swabs dipped in the chlorhexidine preparation. ticipants (40/centre).
considered statistically significant, and the statistical analyses were Support of nitrous oxide was common at anaesthesia/sedation in
done using SPSS version 22 (IBM Corp., Armonk, NY, USA). both intervention groups (Table 2). Registration of surgery time for
one patient in the open exposure group was missing; consequently,
analysis of mean surgery times was based on 60 patients in the
Results closed group and 58 patients in the open group. There was a slightly
longer surgery time, although non-significant, in the closed exposure
Sample characteristics
group than in the open group (Table 2). Mean surgery time for the
Figure 1 shows the CONSORT flow chart. All 119 patients, 75 girls,
bilateral cases were 12.7 min (closed group) and 14.6 min (open
and 44 boys, with a mean age of 13.4 years (SD 1.46) completed this
group) longer than those in the unilateral cases. No statistically sig-
part of the trial, in which they were followed 4 weeks post-surgery.
nificant differences were found in the exposure characteristics or sur-
There were 54 studied canines on the right side and 65 on the left
gery time between the two interventions (Table 2).
side (Table 1). Age, gender, and tooth position distributions were
The numbers of surgical complications within 4 weeks post-
similar with no significant differences between the two intervention
surgery were similar in the two intervention groups, although the
groups (Table 1).
n % n %
Tooth
13 27 45.0 27 45.8
23 33 55.0 32 54.2
Uni- and bilateral cases
∗The canine in the more severe position, according to the sector position inclusion criteria, was chosen as study tooth in bilateral PDC cases.
The number of bilateral cases according to centre was 7 in closed and 4 in open exposure in Centre I, 6 in closed and 7 in open exposure in Centre II and 2 in
closed and 4 in open exposure in Centre III.
n % n %
Surgery time 35.4 16.4 31.8∗ 15.8 3.6 (-2.26 – 9.48) 0.226
Unilateral cases 32.2 14.9 28.0 12.9 4.2 (-1.69 – 10.14) 0.159
Bilateral cases 44.9 17.6 42.6 18.5 2.3 (-11.23 – 15.77) 0.733
∗ 58 subjects Student´s t-test was used for statistical analysis of continuous data (surgery time).
when only unilateral PDCs were analysed, with one swelling case in There were no significant differences between the intervention
the closed and two swelling cases in the open exposure group. When groups in other VAS scale questions or in the binary (yes/no) out-
the bilateral cases were included, there were more ‘severe’ complica- comes of consumption of analgesics post-surgery for the evening on
tions in the open exposure group, consisting of two swelling cases, the day of operation. The most frequently mentioned discomfort fac-
one bleeding case and two infection cases (P = 0.023; Table 3). tors at operation were injection, drilling and sewing (valid n = 25
and 23 for closed and open exposure groups, respectively).
Patients’ perceptions The outcomes from patient perceptions in the 7 days post-surgery
Both questionnaires were returned by 116 participants, giving a questionnaire (Supplementary Appendix 2) showed significantly
response rate of 97.5%. The outcomes from the questionnaire that more pain (P = 0.010) in the open exposure group (Table 4). Pain
referred to patient perceptions in the evening on the day of opera- 7 days post-surgery significantly correlated to postoperative pain in
tion (Supplementary Appendix 1) showed significantly higher pain the evening on the day of operation (Spearman’s rho = 0.410).
scores at injection of local anaesthetics in the closed group, while The pain and discomfort measures were also explored by cen-
post-surgery pain showed significantly higher pain scores in the open tre, and although there were clear variations and differences between
group in (Table 4). centers for pain at injection, discomfort at injection and discomfort at
M. Björksved et al.
Severe complications
Infection 2 3.4 2 1 5 1 5.3
Bleeding 1 1.7 1 1 5
Swelling/ discomfort 1 1.7 4 6.8 2 1 5 4 21
Total severe complications 1 1.7 0 7 11.9 5 1 1 1 5
Minor complications
Gingival overgrowth/ loss n.a. 4 6.8 n.a. 1 5 n.a. 1 5 n.a. 2 10.5
of glass ionomer
Suture loss/ discomfort 3 5.0 1 1.7 1 5 3 15
Hanging chain* 9 15.0 4 n.a. 2 10 n.a. 7 35 n.a. n.a.
Total minor complications 12 20.0 4 5 8.5 0 2 2 7 1 3 2
No complications 47 78.3 11 47 79.7 10 17 85 17 85 13 65 18 90 17 85 12 63.2
Table 4. Patient perception outcomes in the evening on the day of operation and 7 days post-surgery, measured in VAS scales. Masticatory and Nonmasticatory difficulties measured in cat-
egorical scales.
Mann WhitneyU
Median IQR Min-Max Median IQR Min-Max Median difference* 95% CI P
Pain injection 28.0 9.0 – 60.0 0–100 15.0 3.5 – 46.5 0–98 8.0 0.0 – 18.0 0.044
Discomfort Injection 21.0 6.0 – 56.0 0–100 13.0 3.5 – 52.5 0–98 4.0 -2.0 – 13.0 0.179
Pain operation 2.0 0.0 – 9.0 0–84 2.0 0.0 – 10.5 0–80 0.0 0.0 – 2.0 0.470
Discomfort operation 7.0 2.0 – 22.0 0–79 8.0 1.0 – 34.5 0–83 0.0 -5.0 – 3.0 0.861
Pain post-surgery 28.0 6.0 – 53.0 0–97 43.0 27.5 – 65.5 2–94 -15.0 -26.0 - -5.0 0.004
Discomfort post-surgery 19.0 5.0 – 48.0 0–97 30.0 11.5 – 47.5 0–98 -3.0 -13.0 – 5.0 0.439
Pain 7 days post-surgery 3.0 0.0 – 15.0 0–73 11.5 2.0 – 27.8 0–95 -4.0 -10.0 – 0.0 0.010
Discomfort 7 days post-surgery 8.0 1.0 – 21.0 0–84 18.0 2.0 – 30.5 0–91 -3.0 -10.0 – 0.0 0.150
Masticatory difficulties (scale range 4–16) 7.0 5.0 – 8.0 4–14 7.0 6.0 – 9.0 4–14 -1.0 -2.0 – 0.0 0.050
Nonmasticatory difficulties (scale range 5–20) 5.0 5.0 – 6.0 5–10 6.0 5.0 – 7.0 5–13 0.0 -1.0 – 0.0 0.003
n % n % Chi square P
Analgesic in the evening on the day of 47 78.3 52 88.1 0.078
operation
Analgesic 7 days post-surgery 36 61.0 40 71.4 0.238
Home from school 21 36.2 28 50.0 0.137
Home from activities 17 28.8 20 35.7 0.428
Wakened at night 6 10.3 16 28.6 0.014
Mann Whitney U test were used for statistical analysis of ordinal data and Chi Square test for categorical data. IQR stands for interquartile range.
*Median differences were computed according to Hodges Lehmann (see ref. 20).
European Journal of Orthodontics, 2018, Vol. 40, No. 6
operation (data not shown), the pattern of higher pain scores (post- There were no significant differences between the exposure
surgery and after 7 days) for the open surgery group was consistent. groups in questions about whether they were well taken care of
Significantly more patients had been wakened at night at operation (P = 0.242) and whether they would again choose to
(P = 0.014) in the open exposure group (Table 4). Ten patients who undergo the operation (P = 0.196).
were wakened at night, all in the open exposure group, were also
bilateral cases (data not shown). Other patients’ perceptions of dis-
Discussion
comfort 7 days post-surgery, intake of analgesics, or staying home
from school or activities showed no significant differences between The main findings in the present trial were that patients experienced
the intervention groups (Table 4). The mean time for staying home significantly more post-surgery pain and impairment in the open
from school (among those who did) was 1.5 days (SD 0.68) in the group than in the closed group.
closed group and 1.9 days (SD 1.40) in the open group. Looking at each primary outcome separately, it was found that
The masticatory difficulty index (Cronbach’s α = 0.83), aimed to surgery time did not differ significantly between the two interven-
assess patient perceptions of functional jaw impairment, was not sig- tions with just a bit more than half an hour as the mean surgery
Figure 2. Chewing difficulties reported for different kinds of food, in the questionnaire for 7 days post-surgery. The number of respondents varied between 47
and 59 per group, in the different food items.
634 European Journal of Orthodontics, 2018, Vol. 40, No. 6
Complications were recorded within 4 weeks post-surgery, and for assessment of patients’ perceptions for 7 days post-surgery, and
the numbers of total complications in unilateral PDCs were quite called the patients daily to encourage them to complete the question-
similar in the two intervention groups. The complications in the naire (12). The latter study, though, compared closed and open expos-
closed group, though, may be considered milder than those in the ure technique in both canines and central incisors in mixed positions
open group when bilateral cases were concerned. The registered and incomplete specification of type of teeth per position (12). They
severe complications, such as infection (antibiotics administered), found that pain 3 to 5 days post-surgery and analgesic consumption
bleeding, and swelling, were more numerous in the bilateral cases were significantly higher in the open than in the closed exposure group,
in the open exposure group. However, the majority of these severe which is partly supported by the pain outcomes in the present trial,
complications came from one centre (Table 3). Keeping in mind that while analgesic consumption did not differ between exposure groups.
all operators were experienced surgeons and were calibrated before In any event, it is likely that the differences between studies, accord-
the start of the trial, this difference could be due to chance. It is also ing to whether free analgesic was provided post-surgery, have affected
reasonable to assume that bilateral cases may be more complicated the results. In the present trial, there was no free analgesic provided,
than unilateral cases and consequently more prone to complications, unlike in the studies by Gharabei et al. and Parkin et al. (9, 11), but not
Complications were similar between the exposure groups in patients with palatally impacted maxillary canines. American Journal of
unilateral cases and more common in the open exposure group in Orthodontics and Dentofacial Orthopedics, 119, 216–225.
bilateral cases. 8. Bazargani, F., Magnuson, A., Dolati, A. and Lennartsson, B. (2013)
Palatally displaced maxillary canines: factors influencing duration and
More patients in the open group experienced pain and impair-
cost of treatment. European Journal of Orthodontics, 35, 310–316.
ment compared to the closed group.
9. Gharaibeh, T.M. and Al-Nimri, K.S. (2008) Postoperative pain after sur-
gical exposure of palatally impacted canines: closed-eruption versus open-
eruption, a prospective randomized study. Oral Surgery, Oral Medicine,
Supplementary material
Oral Pathology, Oral Radiology, and Endodontics, 106, 339–342.
Supplementary material is available at European Journal of 10. Pearson, M.H., Robinson, S.N., Reed, R., Birnie, D.J. and Zaki, G.A.
Orthodontics online. (1997) Management of palatally impacted canines: the findings of a col-
laborative study. European Journal of Orthodontics, 19, 511–515.
11. Parkin, N.A., Deery, C., Smith, A.M., Tinsley, D., Sandler, J. and Benson,
Funding P.E. (2012) No difference in surgical outcomes between open and closed