European Journal of Orthodontics, 2018, 626–635

doi:10.1093/ejo/cjy070
Advance Access publication 13 October 2018

Randomized Controlled Trial (RCT)

Closed vs open surgical exposure of palatally

displaced canines: surgery time, postoperative
complications, and patients’ perceptions: a

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multicentre, randomized, controlled trial
Margitha Björksved1,2, Kristina Arnrup3,4, Rune Lindsten5, Anders Magnusson5,
Anna Lena Sundell6, Annika Gustafsson7 and Farhan Bazargani2,8
1
Department of Orthodontics, Public Dental Health Service, Eskilstuna, Sweden, 2Department of Orthodontics,
Postgraduate Dental Education Center, Örebro, Sweden, 3Dental Research Department, Public Dental Service,
Region Örebro County, Örebro, Sweden, 4School of Health Sciences, Örebro University, Örebro, Sweden, 5Department
of Orthodontics, The Institute for Postgraduate Dental Education, Jönköping, Sweden, 6Department of Paediatric
Dentistry, The Institute for Postgraduate Dental Education, Jönköping, Sweden, 7Department of Paediatric Dentistry,
Postgraduate Dental Education Center, Örebro, Sweden and 8School of Medical Sciences, Faculty of Medicine and
Health, Örebro University, Örebro, Sweden

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: farhan.bazargani@regionorebrolan.se

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.
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.
Introduction
Palatally displaced canines (PDCs) are a frequent dental anomaly,
present in 2%–3% of the European young population (1, 2). If
interceptive treatment with extraction of deciduous canines in PDC
cases is unsuccessful, surgical exposure with subsequent orthodontic
appliance treatment should be considered. Two surgery techniques
for exposing palatal canines are routinely used: the closed technique
and the open technique.
Closed technique involves surgical uncovering of the canine
with a full-thickness mucoperiosteal flap dissected off the bone.
The bone covering the canine is removed and an attachment with a
chain is bonded to the exposed tooth. The palatal flap is repositioned
and sutured back with the chain penetrating through the mucosa.
Orthodontic force is applied and the canine is moved beneath the
palatal mucosa (3). Open technique involves surgical uncovering of
the canine, with removal of a window of mucoperiosteal tissue from
around the tooth and placement of a pack to cover the exposed area
(4). The continuing treatment approaches vary after removal of tis-
sue, depending on whether an attachment is bonded to the exposed
tooth at surgery or after removal of pack or if spontaneous eruption
is allowed post-surgery.
According to an unpublished survey, conducted by one of the
authors of the present trial, among Swedish orthodontists in 2012,
80% used the closed technique, 9% used the open technique, and
11% used both exposure techniques. This may be compared to a
similar survey, performed in the UK, where 55% included closed
technique in their treatments, while 45% never did closed exposures
(5). Recently, higher rates of open exposure technique have been
reported also in Sweden (6). Treatment options seem to be left to
the personal choice of the surgeons and orthodontists, even though
the management of PDCs is a multidisciplinary and time-consuming
treatment (7) affecting patients and their families in different ways in
daily life and contributing to relatively high societal costs (8).
There is no consensus in the literature regarding the surgical
techniques, and studies show diverseness in different outcomes.
Surgery time seems to favour open technique (9, 10), while results of
post-surgery complications differ (10, 11) and post-surgery pain dur-
ation seems to favour closed technique (9, 12). There is insufficient
evidence today to support one technique over the other; therefore,
the subject warrants randomized controlled trials (13, 14).
The purposes of this RCT were to compare closed and open sur-
gical techniques in PDC cases for surgery time, complications, and
patients’ perceptions, such as experience of pain, discomfort, anal-
gesic consumption, and impact on daily activities.
Material and methods
The trial design was a multicentre randomized controlled trial,
with two parallel groups and allocation according to a 1:1 ratio.
The regional ethical review board in Uppsala, Sweden, approved the
study protocol, informed consent and questionnaires (protocol nr.
2013/091).
627
Participants, eligibility criteria, and setting
The trial was conducted at the Departments of Orthodontics in
Eskilstuna (centre I), Örebro (centre II) and Jönköping (centre III),
Sweden (country) and the study participants were included consecu-
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tively from the three orthodontic centres between January 2014 and
February 2017.
The inclusion criteria were uni- or bilateral PDCs planned for
surgical exposure and orthodontic alignment, canine cusp tip pos-
ition (documented by panoramic radiographs) from long axis of
lateral incisor up to sector IV (15, 16), dental development stage
maxillary DS2M1 and DS3M2 according to Bjoerk (17), and age not
more than 16 years at surgical exposure.
The exclusion criteria were disease affecting the somatic or craniofa-
cial growth, disease not compatible with anaesthesia or surgery, known
neuropsychiatric diagnosis, vertical position of the PDCs above the full-
length root of the adjacent lateral or central incisor, aplasia of the adja-
cent lateral incisor, or active ongoing orthodontic treatment. PDCs in
sector V were not included in the trial due to the impactions severity,
which often is subjected to treatment with the closed technique.
Clinical interventions
Closed technique
- The canine was surgically uncovered with a full-thickness muco-
periosteal flap dissected off the bone.
- The bone covering the canine was removed with a punch or bur;
NaCl irrigation.
- Attachment with a chain was bonded to the exposed tooth. Swab
gauze 1.5 × 1.5 cm and tranexamic acid (Cyklokapron 5%)
could be used to get a dry operation field.
- The palatal flap was repositioned and sutured back with the
chain extending through an incision in the palatal flap.
Open technique
- The canine was surgically uncovered with a full-thickness muco-
periosteal flap dissected off the bone.
- The bone covering the canine was removed with a punch or bur;
NaCl irrigation.
- Polyacrylic acid and then conventional, light cured glass iono-
mer cement were applied on the surface of the crown of the
impacted canine, to the level of intact mucosa (18). Swab gauze
1.5 × 1.5 cm and tranexamic acid (Cyklokapron 5%) could be
used to get a dry operation field.
- The palatal flap was repositioned and sutured back, and a win-
dow of mucoperiosteal tissue overlying the tooth was removed
with a punch or a scalpel.
All patients were given verbal and written information with
recommendations of:
• Analgesic (paracetamol as first choice) 1 h before operation and
thereafter every 6 to 8 h for 2 days post-surgery, according to the
dosage recommendation.
628
• Chlorhexidine preparation 0.12% mouth rinse (Paroex®) two
times a day post-surgery for 7 to 10 days. If the child has difficul-
ties rinsing, the operation field may be cleaned with Oraclean
mouth swabs dipped in the chlorhexidine preparation.
Primary outcome measures
The outcome measures were collected from dental records and
questionnaires. Surgery time was measured in minutes, from start
of incision to the last suture. Surgical complications were all com-
plications (swelling, bleeding, infection, etc.) that were registered
from operation until 4 weeks post-surgery. Complications of bleed-
ing and swelling from the operation area were events that were
considered to need a dental care visit, initiated by parents calling
the dental clinic for supervision, while infection was defined as
need of antibiotics. Patient perceptions, such as experience of pain,
discomfort, analgesic consumption, impact on daily activities and
functional jaw impairment were analysed from two questionnaires,
one the evening on the day of operation and one 7 days post-
surgery. The questionnaires have been found to be reliable and to
have sufficient internal consistency in previous studies (19, 20). The
responses in the questionnaires contained visual analogue scales,
binary (yes/no) and four-point scales, and rows where the patients
were able to write answers in their own words (see Supplementary
Appendices). The questions with horizontal 100 mm VAS had the
end phrases not at all and worst imaginable, and a standard metric
ruler was used in measurement of the VAS scale value, assessed
to the nearest millimetre. The questions using a four-point scale,
questions 3 and 4 in the 7 days post-surgery questionnaire, con-
sisted of the alternatives not at all, slightly difficult, very difficult
and extremely difficult (Supplementary Appendix 2). Question 3 in
the 7 days post-surgery questionnaire addressed daily activities and
functional jaw impairment (‘If you have pain or discomfort in your
teeth and jaws, how much does it affect you?’). The items in ques-
tion 3 were grouped as masticatory or non-masticatory difficulties.
The items 3 (take a big bite), 4 (chew hard food), 5 (chew soft
food), and 9 (chew against resistance) were grouped as an index
of masticatory difficulties, and items 1 (leisure time), 2 (speech), 6
(schoolwork), 7 (drinking), and 8 (laughing) were grouped as an
index of nonmasticatory difficulties (20).
Secondary outcome measures
The canine sector and angle position were assessed in panoramic
radiographs. The canines included in the study had a sector position
with canine cusp tip from the long axis of the lateral incisor up to
sector IV (15, 16). The long axis of the incisor was defined as the line
through the radiological centre of the incisal edge and apex; sector
III was the area from the long axis of the lateral incisor to the line
bisecting the approximal area between the lateral and central incisor.
Sector IV was the area from the line bisecting the approximal area
between the lateral and the central incisor to the long axis of the cen-
tral incisor. Canine angle position was defined as the angle between
the long axis of the canine and the midline, where the midline was
defined as the line from the spina nasalis anterior through the alveo-
lar process at the intermaxillary suture.
Sample size
Sample size calculation was based on the total treatment time as
the primary outcome for the overall trial. The difference in mean
total treatment time between the surgical methods in a previous ret-
rospective study (10) was 4 months (SD 6). To reach a power of
European Journal of Orthodontics, 2018, Vol. 40, No. 6
90% with an alpha of 5%, 48 participants per group were required.
A presumed dropout rate of 15% (21) resulted in inclusion of 111
participants, and another 9 were included to give a total of 120 par-
ticipants (40/centre).
Randomization, allocation, and procedures
The clinicians gave the potential study participants and their parents
verbal and written information about the trial at the appointment
where they received information about treatment. The potential
study participants and their parents were allowed at least one week
to decide whether they wanted to participate in the trial, and the
written consent was submitted to the orthodontic centre in ques-
tion. After informed consent was obtained, the study participants
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were randomly allocated in blocks of different sizes, according to a
computer-generated randomization list, using concealed allocation.
A statistician, who was not involved in the trial, provided the rand-
omization list, and stratification was made for each centre. Allocation
concealment was held by one individual per centre, who was not
involved in the trial, and who was contacted by the treating clinician
at the time for allocation. Study surgeons in two of the centres were
two specialists in paediatric dentistry (one per centre), and a clinician
with special training in surgery in the third centre. All study surgeons
had many years of surgical experience and were calibrated prior to
the study, operating minimum of 10 patients each with either tech-
nique. The surgical exposure protocols were discussed and agreed to
among the surgeons before start of the study. Also, all patients had
CBCT scans taken for diagnosis of possible pathology, prior to inclu-
sion in the study. The CBCT scans were available for surgeons at the
time of surgery to facilitate the localization of the PDCs in all cases.
If the maxillary deciduous canine was present, and the PDC cusp
tip had a sector III position at examination, the deciduous canine
was removed and the PDC sector position was controlled 6 months
later. If the PDC cusp tip in these cases still had a sector position
according to the inclusion criteria 6 months later, the patients were
asked about participation in the trial at this time. In the bilateral
cases, the canine in the more severe position according to the inclu-
sion criteria was chosen as the study tooth.
The surgery personnel handed out two questionnaires, together
with written post-surgery information, to all patients after the opera-
tion. The questionnaires aimed to assess the participant’s experience
of pain or discomfort, their analgesic consumption, and the impact
on daily activities and functional jaw impairment in the evening of
the operation day and 7 days post-surgery. The participants were
asked to submit the questionnaires at the first post-surgery follow-up
in the orthodontic centre.
Blinding
It was not possible to blind either study participants or care provid-
ers to the interventions, for obvious reasons. However, prior to data
analysis, the outcome assessors were blinded and were unaware of
patients’ intervention group.
Statistical methods
Student’s t-test was used for analysis of continuous data. Chi-square
test, Fischer’s exact test, and Mann–Whitney U test were used for cate-
gorical data. Median differences were computed according to Hodges
Lehmann (22). Cronbach’s alpha was used to analyse internal con-
sistency for the masticatory and non-masticatory indexes. Spearman’s
rank correlation coefficients were calculated to examine correlations
between different outcomes in the two questionnaires. A P < 0.05 was
M. Björksved et al.
considered statistically significant, and the statistical analyses were
done using SPSS version 22 (IBM Corp., Armonk, NY, USA).
Results
Sample characteristics
Figure 1 shows the CONSORT flow chart. All 119 patients, 75 girls,
and 44 boys, with a mean age of 13.4 years (SD 1.46) completed this
part of the trial, in which they were followed 4 weeks post-surgery.
There were 54 studied canines on the right side and 65 on the left
side (Table 1). Age, gender, and tooth position distributions were
similar with no significant differences between the two intervention
groups (Table 1).
Exposure characteristics, surgery time, and surgical
complications
About half of the patients had an intake of analgesics pre-surgery
and about 20%–25% had anticoagulant agent at surgery (Table 2).
Figure 1. CONSORT flow chart
629
Support of nitrous oxide was common at anaesthesia/sedation in
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
closed group and 58 patients in the open group. There was a slightly
longer surgery time, although non-significant, in the closed exposure
group than in the open group (Table 2). Mean surgery time for the
bilateral cases were 12.7 min (closed group) and 14.6 min (open
group) longer than those in the unilateral cases. No statistically sig-
nificant differences were found in the exposure characteristics or sur-
gery time between the two interventions (Table 2).
The numbers of surgical complications within 4 weeks post-
surgery were similar in the two intervention groups, although the
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types of complications differed (Table 3). The complications were
divided into minor and severe complications. ‘Minor’ complications
consisted of loss of or discomfort from suture, hanging chain and
gingival overgrowth (which included loss of glass-ionomer cement),
and ‘severe’ complications consisted of swelling, bleeding or infec-
tion. Severe complications were similar between intervention groups
630 European Journal of Orthodontics, 2018, Vol. 40, No. 6

Table 1. Sample characteristics

Closed exposure (n = 60) Open exposure (n = 59)

n Mean age SD n Mean age SD

Total 60 13.5 1.6 59 13.3 1.3

Boys 20 14.0 1.4 24 13.5 1.0
Girls 40 13.3 1.6 35 13.2 1.5

n % n %

Tooth
13 27 45.0 27 45.8
23 33 55.0 32 54.2
Uni- and bilateral cases

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Unilateral 45 75.0 44 74.6
Bilateral∗ 15 25.0 15 25.4
Canine sector position
Sector III 31 51.7 36 61.0
Sector IV 29 48.3 23 39.0

Mean (°) SD Mean (°) SD

Canine angle to midline 32.4 7.53 32.4 8.20

∗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.

Table 2. Exposure characteristics and surgery time

Closed exposure Open exposure

(n = 60) (n = 59)

n % n %

Analgesic pre-surgery 33 55.0 27 45.8

Anticoagulant agent 12 20.0 15 25.4
at surgery
Anesthesia/ Sedation
Local anesthetics (LA) 20 33.3 18 30.5
LA combined with Nitrous oxide 34 56.7 33 55.9
LA combined with Midazolam 5 8.3 7 11.9
General anesthesia 1 1.7 1 1.7

Mean SD Mean SD Mean diff (95% CI) P

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
the closed and two swelling cases in the open exposure group. When
the bilateral cases were included, there were more ‘severe’ complica-
tions in the open exposure group, consisting of two swelling cases,
one bleeding case and two infection cases (P = 0.023; Table 3).
Patients’ perceptions
Both questionnaires were returned by 116 participants, giving a
response rate of 97.5%. The outcomes from the questionnaire that
referred to patient perceptions in the evening on the day of opera-
tion (Supplementary Appendix 1) showed significantly higher pain
scores at injection of local anaesthetics in the closed group, while
post-surgery pain showed significantly higher pain scores in the open
group in (Table 4).
There were no significant differences between the intervention
groups in other VAS scale questions or in the binary (yes/no) out-
comes of consumption of analgesics post-surgery for the evening on
the day of operation. The most frequently mentioned discomfort fac-
tors at operation were injection, drilling and sewing (valid n = 25
and 23 for closed and open exposure groups, respectively).
The outcomes from patient perceptions in the 7 days post-surgery
questionnaire (Supplementary Appendix 2) showed significantly
more pain (P = 0.010) in the open exposure group (Table 4). Pain
7 days post-surgery significantly correlated to postoperative pain in
the evening on the day of operation (Spearman’s rho = 0.410).
The pain and discomfort measures were also explored by cen-
tre, and although there were clear variations and differences between
centers for pain at injection, discomfort at injection and discomfort at
 M. Björksved et al.

Table 3. Surgical complications within 4 weeks post-surgery

Intervention groups in total Centre I Centre II Centre III

Closed Open Closed Open Closed Open

Closed exposure Open exposure exposure exposure exposure exposure exposure exposure
(n = 60) (n = 59) (n = 20) (n = 20) (n = 20) (n = 20) (n = 20) (n = 19)

n % Bilateral cases n % Bilateral cases n % n % n % n % n % n %

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

n.a. = Not applicable

* Hanging chain cases were closed exposure cases where no orthodontic force was applied at operation. Instead the chain was temporarily bonded to an adjacent tooth. In the “hanging chain” cases the chains were
rebonded to an adjacent tooth until orthodontic force was applied 1 – 2 weeks later.
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 632

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.

Closed exposure Open exposure

(n=58–59) (n=53–57)

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

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M. Björksved et al.
operation (data not shown), the pattern of higher pain scores (post-
surgery and after 7 days) for the open surgery group was consistent.
Significantly more patients had been wakened at night
(P = 0.014) in the open exposure group (Table 4). Ten patients who
were wakened at night, all in the open exposure group, were also
bilateral cases (data not shown). Other patients’ perceptions of dis-
comfort 7 days post-surgery, intake of analgesics, or staying home
from school or activities showed no significant differences between
the intervention groups (Table 4). The mean time for staying home
from school (among those who did) was 1.5 days (SD 0.68) in the
closed group and 1.9 days (SD 1.40) in the open group.
The masticatory difficulty index (Cronbach’s α = 0.83), aimed to
assess patient perceptions of functional jaw impairment, was not sig-
nificantly different between the intervention groups (P > 0.050). The
non-masticatory difficulty index (α = 0.82), though, aimed to assess
patient perceptions of impact on daily activities, was significantly
different between the intervention groups (P = 0.003), Table 4. Item
10 (yawning) and item 11 (kissing) in question 3 in the 7 days post-
surgery questionnaire (Supplementary Appendix 2) were excluded in
the analysis due to few responses.
Patients’ perceptions of functional jaw impairment in terms of
the degree of difficulty when eating different kinds of food (question
4 in the 7 days post-surgery questionnaire, Supplementary Appendix
2) are shown in Figure 2. Although the number of responses varied
(between 47 and 59 in the closed group and between 49 and 54 in
the open group), it was clear that eating meat, peanuts, apples, and
soft cookies was more difficult in the open group than in the closed
group (Figure 2).
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.
633
There were no significant differences between the exposure
groups in questions about whether they were well taken care of
at operation (P = 0.242) and whether they would again choose to
undergo the operation (P = 0.196).
Discussion
The main findings in the present trial were that patients experienced
significantly more post-surgery pain and impairment in the open
group than in the closed group.
Looking at each primary outcome separately, it was found that
surgery time did not differ significantly between the two interven-
tions with just a bit more than half an hour as the mean surgery
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time, which is in concordance with an RCT performed by Parkin
et al. (11), while Gharabei et al. reported a significantly shorter
mean surgery time for the open as compared to close surgery tech-
nique (30.9 vs. 37.7 min) from a quasi-randomized trial (9). The
differences between the studies could be ascribed partly to the
small sample sizes and partly to the risk of selection bias, due to
the nature of allocation in quasi-randomized trials. In the present
trial, as in the studies conducted by Gharabei et al. (9) and Parkin
et al. (11), whole mucoperiosteal flaps were raised in both groups
and surgery times were measured from start of incision until the
last suture. Both Gharabei et al. and Parkin et al. sutured a pack
in the exposed operation area and removed it 10 and 7 days post-
surgery, respectively, in the open exposure, while the present trial
used glass ionomer cement (18) on the canine crown, to prevent
gingival overgrowth during spontaneous eruption.
634
Complications were recorded within 4 weeks post-surgery, and
the numbers of total complications in unilateral PDCs were quite
similar in the two intervention groups. The complications in the
closed group, though, may be considered milder than those in the
open group when bilateral cases were concerned. The registered
severe complications, such as infection (antibiotics administered),
bleeding, and swelling, were more numerous in the bilateral cases
in the open exposure group. However, the majority of these severe
complications came from one centre (Table 3). Keeping in mind that
all operators were experienced surgeons and were calibrated before
the start of the trial, this difference could be due to chance. It is also
reasonable to assume that bilateral cases may be more complicated
than unilateral cases and consequently more prone to complications,
and—as it may seem—especially in open exposures.
If only complications which are comparable to that reported in
other studies are taken into account, the complications (infection
requiring antibiotics or gingival overgrowth) in the present trial
would be 0% in the closed group and 10.2% (6 of 59) in the open
group. Summarizing the complications described by Parkin et al.,
there were 8.6% (3 of 35) in the closed group, one bond failure,
one infection (antibiotics administered) and one re-exposure due to
replacement of attachment (11). In the open group, they found that
12.9% (4 of 31) required re-exposure: three cases with gingival over-
growth and one case with slow movement. In the present trial, the
time frame for complications was narrowed in order to cover the
early complications related to the surgery. Such narrow time frame
does not appear in the study conducted by Parkin et al. (11), where
one can assume, though, that it is a matter of complications within
total (surgical and orthodontic) treatment time. Consequently, the
frequency of complications may increase in the present trial when
complications during ongoing orthodontic treatments are included.
In the present trial both ‘minor’ and ‘severe’ complications are
described, while the study by Parkin et al. (11) did not categorize
complications. Moreover, the time frame also differs between the
studies; therefore, comparison may be misleading.
In the present trial, two questionnaires aimed to assess the
patient’s experience of pain, discomfort, analgesic consumption,
impact on daily activities and functional jaw impairment, for
the evening on the day of operation and for 7 days post-surgery.
Significant differences between the two interventions were found
for pain at injection, pain in the evening on the day of operation,
pain 7 days post-surgery, and wakening at night. The difference in
pain at injection between the groups was unexpected, as injection
ought to be similar in the intervention groups. Due to the level and
distribution of the outcome measure data, no multivariate analyses
were performed, but factors that may affect pain, such as pre-surgery
analgesics, kind of anaesthesia/sedation, sex, age or bilateral cases
did not show any significant differences between groups.
The higher pain scores for the open exposure group in the evening
on the day of operation and pain 7 days post-surgery was contra-
dictory to the findings by Parkin et al. (11) and Gharabei et al. (9),
but consistent with the findings by Chaushu et al. (12). Parkin et al.
found no statistically significant differences between the intervention
groups when they used a 10 days post-surgery questionnaire to assess
patient´s perceptions at one time point, even though they found that 6
of the 9 patients who reported pain still present after several days were
in the open group and 3 of the 4 patients who reported no pain were in
the closed group (11). Gharabei et al. used a numerical pain scale from
1 to 10 when they assessed pain for 1–7 days post-surgery and found
no statistically significant differences between intervention groups (9).
Chaushu et al. provided a questionnaire, with VAS scales from 1 to 10
and five-point scales (not at all, very little, some, quite a lot, very much),
European Journal of Orthodontics, 2018, Vol. 40, No. 6
for assessment of patients’ perceptions for 7 days post-surgery, and
called the patients daily to encourage them to complete the question-
naire (12). The latter study, though, compared closed and open expos-
ure technique in both canines and central incisors in mixed positions
and incomplete specification of type of teeth per position (12). They
found that pain 3 to 5 days post-surgery and analgesic consumption
were significantly higher in the open than in the closed exposure group,
which is partly supported by the pain outcomes in the present trial,
while analgesic consumption did not differ between exposure groups.
In any event, it is likely that the differences between studies, accord-
ing to whether free analgesic was provided post-surgery, have affected
the results. In the present trial, there was no free analgesic provided,
unlike in the studies by Gharabei et al. and Parkin et al. (9, 11), but not
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specified in the study by Chaushu et al. (‘medication prescribed’) (12).
Distribution of free analgesic post-surgery provides easy access and
may encourage the patients to take more analgesics than if they had to
acquire analgesic themselves.
In the present trial, there were significantly more patients who
had been wakened at night post-surgery in the open group compared
to the closed group, which may have been due to pain. An observa-
tion among these patients was that 10 of the 16 patients who had
been wakened at night in the open group were bilateral cases, com-
pared to no bilateral cases in the closed group. The bilateral cases
were also well represented in the cases staying home from school
and activities. When Chaushu et al. studied oral function, they found
significantly more impairment in the open group, in ability to enjoy
food, swallow and open the mouth, and in food accumulation (12).
This was supported by the results in the present trial, where the
differences, although minor, in masticatory and non-masticatory
indexes and difficulties when eating several kinds of food indicate
more negative impact from the open surgery technique.
Interpretation
In a short-term perspective, taking the surgery procedure and early
complications into account, our results point in favour for the closed
surgery technique for the exposure of palatally displaced permanent
canines. We do not know, though, how the pain and impairment
levels would affect the patient’s choice of treatment. No patient, par-
ent or care provider would choose more severe complications before
minor ones, if there are no other benefits that overweigh the risks. In
the present study, 4 weeks post-surgery was chosen as a reasonable
time limit for surgical complications, but the trial is ongoing, and the
total number of surgical/orthodontic complications will be reported
in the future. A recent systematic review pointed out some benefits,
such as faster total treatment time and less risk of ankylosis in open
exposure technique (23). These are aspects to be further investigated.
Limitations
The sample size in this part of the trial was based on the sample size
calculation of total treatment time for the overall trial. Still, there
were findings of statistically significant differences between groups.
However, we do not know whether a larger sample size would have
affected the statistically non-significant findings differently.
Generalizability
The result of this RCT can be generalized only in a similar population
aged 9–16 years and in the case that the exclusion criteria are met.
Conclusions
There were no statistically significant differences regarding surgery
time between the groups.
M. Björksved et al.
Complications were similar between the exposure groups in
unilateral cases and more common in the open exposure group in
bilateral cases.
More patients in the open group experienced pain and impair-
ment compared to the closed group.
Supplementary material
Supplementary material is available at European Journal of
Orthodontics online.
Funding
This work was supported by the County Council of Sörmland [grant number
DLL–393721] and Uppsala – Örebro Regional Research Council [grant num-
ber RFR–387041].
Acknowledgements
We thank Dr Gunnar Karlsson for his fine, committed efforts during the years
of surgical interventions. We also thank statistician Anders Magnuson for his
invaluable contribution.
Conflict of interest
The authors declare that they have no conflict of interest.
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