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ORIGINAL ARTICLE
evant to third molar removal5–12. The contemporary evaluate the differences among the six study groups. To
view is that post-operative sequelae after third molar improve the power of study and enhance its internal
surgery influence the patients’ QOL in the immediate validity, a sample size of 12 patients per group was
post-operative period5,8,10. However, only few studies planned for the present clinical trial. This number was
have reported on the effect of the different therapeutic estimated to fit a statistical model for analysing the dif-
agents that can be used perioperatively on patients’ ferences among all study groups, the active and con-
QOL after third molar surgery13,14. trols, together.
Perioperative use of corticosteroids is a pharmaco- Inclusion criteria included partial bony impacted
logical approach often used for reduction of oedema, mandibular third molars with Class II or III and position
trismus and pain after removal of impacted lower third A, B or C, according to Pell and Gregory classification
molars15–17. Corticosteroids act by inhibiting, through a on a radiograph23. All patients were 18 years of age or
variety of proposed mechanisms, the body’s inflam- older, free of pericoronitis and infection at the time of
matory response to injury, with a reduction of fluid surgery.
transudation and therefore oedema15. The use of corti- Exclusion criteria included history of compromised
costeroids has gained wide acceptance in the oral and medical status, history of allergy or hypersensitivity to
maxillofacial surgery community. However, the most the drugs used in this trial, chronic use of any medica-
variable aspect in the use of corticosteroids in oral tion, pregnant or lactating females and patients refused
surgery is the appropriate route of administration. Dif- being involved in the study or those who could not
ferent administration routes have been used for these attend the follow-up visits or those who used non-trial
drugs in oral surgery and every route has its merits and drugs during the observation period.
drawbacks. Numerous reports are now available sup- All relevant demographic information along with
porting the use of systemic corticosteroids18–21 while measurements of mouth opening, cheek flexibility and
others have recently concerned with the local admin- body weight and height were recorded in a case form
istration of corticosteroids in the setting of third molar for each patient. Cheek flexibility was defined as the
surgery13,22. The difference between various routes distance (mm) between the maxillary dental midline
remains to be determined. and the cheek retractor during retraction24. Radio-
The aim of this randomised prospective study was to graphic examination included digital panoramic radio-
compare the effect of dexamethasone in five different graphs taken for all patients prior to operation to
routes of administration on swelling, pain, trismus and identify the radiographic features related to the
QOL measures for patients in the early post-operative impacted third molar using an original apparatus
period after surgical extraction of impacted lower third (Dimax3 Ceph, Planmeca OY, Finland). All patients
molars. were informed that they would be enrolled in the study
and a brief overview regarding the steps of surgery,
medications and the required follow-up was given to
Patients and methods
them. Each patient provided an informed consent to
participate in the study.
Study design and sample
A randomised non-blind prospective study was con-
Surgical procedure
ducted at the Department of Oral and Maxillofacial
Surgery, College of Dentistry, University of Mosul, and A standardised surgical procedure was performed on all
included patients who required surgical removal of a patients by the same right-handed operator in the same
single impacted mandibular third molar under local operating room and under similar conditions. A stand-
anaesthesia. Patients were randomly divided into six ard inferior alveolar and long buccal nerve block was
groups: five treatment groups, in which dexametha- given using 1.8 mL cartridges of 2% lidocaine hydro-
sone 4 mg was given by five different routes, and one chloride with epinephrine 1:100 000. Surgical access
control group. Randomisation was achieved using a routinely achieved buccally through a triangular full
random numbers table. Neither the patients nor the thickness flap. Bone removal around the tooth was
surgeons were blinded to the use of corticosteroids. The then performed with a round bur on a straight hand
study was approved by the local academic committee piece under continuous irrigation with a diluted chlo-
according to relevant guidelines. rhexidine solution. After extraction, the socket was
In order to obtain a study power of 80% at a level of inspected, copiously irrigated, excess follicular tissue
significance equal to 0.05 using a 2-tailed test, a sample removed if present, and the flap was returned to its
size of 10.26 units per group was found necessary to original position, sutured back by two interrupted
stitches using a 3-0 silk suture one of them placed just tragus-canthus of mouth and gonion-lateral canthus.
distal to the lower second molar and the other one The arithmetic mean of these measurements was taken
placed distally. A small gauze pack was then applied on as the final estimate of swelling. The preoperative
the surgical site, and the usual post-extraction instruc- values (in millimetres) were taken as the baseline for
tions were given. Duration of surgery in minutes (from that side.
initial incision to the last suture) was recorded. Trismus was measured as the difference in inter-
incisal distance (in millimetres) at maximum mouth
opening. Again, preoperative measures were consid-
Post-operative medications
ered as baseline.
Patients were randomly divided into six groups, with To measure the effect of surgery on QOL, a modified
12 patients in each. The five treatment groups received questionnaire was used to evaluate quality of life after
4 mg dexamethasone (Dexa-Allvoran®, TAD Pharma third molar extraction. The clinical validity of this
GmbH, Legmo, Germany) as submucosal, intramuscu- questionnaire was demonstrated in a previous study by
lar and intravenous injection; and as oral tablets and its ability to discriminate between different groups of
endoalveolar application of dexamethasone powder patients and its good correlation with the objectively
(Dekort®, Deva Holding A, Turkey), respectively. All measured variables14. The questionnaire involved dif-
injections were given immediately after surgery. Sub- ferent items addressing social isolation, working isola-
mucosal dexamethasone was injected into the buccal tion, eating ability and diet variations, speaking ability,
vestibule near the surgical site, while intramuscular sleep impairment and physical appearance. After
injection was given in the deltoid muscle, and the giving a simple overview about these items, each
intravenous dexamethasone was injected through the patient received the questionnaire to be filled on day 4
veins of forearm. Oral tablets were taken as four doses after surgery and returned at the time of suture
of 1 mg every 6 h in the first post-operative day. removal by day 7. They were instructed to answer the
Endoalveolar dexamethasone was applied incremen- questions and rate on a 4-point scale (never to very
tally into the extraction socket using a small plastic much) their experience of third molar surgery. The
spoon with a long handle, followed by careful packing total score range is (0 - 42). The questionnaire also
to avoid spreading of the powder before suturing the included questions about the duration of effect on each
wound edges onto it. In the sixth group (control), element of QOL to be recorded by patients on day 7.
patients received no corticosteroid treatment.
In addition, all patients in the study routinely
received amoxicillin (oral 500 mg every 8 h) for 5 days Statistical analysis
following surgery and tramadol tablets (oral 50 mg on Data were processed using the Statistical Package for
need) as a rescue analgesic. A chlorhexidine mouth Social Sciences, version 12 (SPSS, Chicago, IL). A
rinse was prescribed twice daily to be started the day descriptive analysis of each variable under study was
after surgery and for 5 days. made. Demographic and clinical characteristics of
the patients were analysed by analysis of variance
Assessment and follow-up (ANOVA) or Pearson chi-square (c2) test, as appropri-
ate. ANOVA was also used to compare QOL scores
Each patient was seen and assessed at the first, third and duration of effect among different groups. Post
and seventh post-operative days by an independent hoc analyses were performed by Duncan’s test.
examiner who was already familiarised to evaluate P-values < 0.05 were considered significant.
different study parameters. Facial pain, swelling and
trismus were measured. Post-operative pain was
Results
evaluated using a visual analogue scale (VAS), 10 cm in
length, ranging from 0 = ‘no pain’ to 10 = ‘the worst
Demographic data
possible pain’. Patients were also instructed to report
the number of rescue analgesic tablets required on the A total of 72 patients were included in the study
day of surgery (6 h post-operatively) and on each sub- and completed the questionnaire and measurements.
sequent day of follow-up for the first post-operative There were no missing data, and the patients included
week. in this study attended all the study visits. The mean age
Facial swelling in the operation side was evaluated of patients in total (32 males and 40 females) was 25.6
by assessing three facial measurements using flexible (⫾ 5.9) with a range of (18–48). Data about demo-
length measuring tape25: Tragus-midline (pogonion), graphic and clinical characteristics of patients and
Age (years) 23.5 (4.2) 30 (9) 23.7 (4.6) 25.4 (3.6) 25 (2.7) 24 (3.3) 25.5 (5.8) 0.041†
Gender
Male 4 8 4 4 8 3 32 0.137‡
Female 8 4 7 8 4 9 40
Smoking
Yes 1 3 1 0 2 2 9 0.532‡
No 11 9 11 12 10 10 63
BMI (kg/m2) 24 (2.2) 28.7 (3.7) 23.5 (3) 24.7 (2.7) 24.6 (3) 23.3 (6) 24.8 (4) 0.054†
Difficulty score 6.4 (0.9) 6.7 (0.7) 7 (1.1) 6.1 (0.6) 6.3 (0.5) 6.3 (0.6) 6.4 (0.8) 0.351†
IID (mm) 46.1 (5.7) 44.6 (4.8) 45.6 (4.6) 44.4 (3.7) 47.3 (7.9) 43.7 (7.6) 45.3 (5.8) 0.724†
Cheek flexibility (mm) 47.4 (5) 48.7 (4.7) 52.5 (4.4) 45 (5) 48.8 (6.5) 45 (2.8) 48 (53) 0.125†
Duration (minutes) 36.5 (8.5) 42.5 (13) 31 (9.6) 31 (4.5) 29.5 (5) 34.6 (4.3) 35.7 (9.3) 0.064†
14
13.5
Control
Swelling (mm)
IM 13
SM
12.5
Oral
IV 12
EA
11.5
11
Pre Day 1 Day 3 Day 7
50
45
Inter-incisal distance (mm)
Pain (VAS)
SM 4
Oral 3 Effect on QOL
IV
2
EA All dexamethasone groups showed highly significant
1
differences regarding the effect on QOL in all subscale
0 scores (P < 0.01) as compared with the control group
Day 1 Day 3 Day 7
(Table 3). The difference was also significant for the total
Figure 4 Profile mean of pain measurements at follow-up check points of duration of effect on QOL among the groups. However,
study groups. IM, intramuscular; SM, submucosal; IV, intravenous; EA, the effect was comparable among the treatment groups
endoalveolar, VAS, visual analog scale. in all parameters. Intravenous group showed the lowest
scores followed by submucosal group.
When the duration of effect on QOL was compared,
Trismus, on the other hand, was significantly worsened patients in the control group revealed impairment in
at the same interval in all groups. Pain (on VAS) also their life activities, represented by the total QOL score,
reached its peak on day 1 and faded away by day 7 for an average of 2.8 days (range 2–4) after surgery. On
(Fig. 4). The latter effect was reflected on the number of the other hand, the average duration of impaired QOL
rescue analgesic taken at each interval, which showed in the treatment groups was 1.2 days (range 0–2) post-
significantly higher counts on day 1 after surgery operatively (Table 4). The duration was significantly
except in the control group where patients reported shorter in the treatment groups as compared to controls
more analgesic consumption during the second and for all subscales except for ‘sleep’ score. In total, the
third post-operative days (Table 2). shortest impairment reported by patients was in the
intravenous group followed by oral and submucosal
Profile of measurements among groups groups in an ascending order.
Swelling (Cm) ‡
Day 1 5.2 (0.8) 1.2 (1.1)* 1.5 (0.6)* 2.2 (0.8)* 0.9 (0.3)* 2.3 (0.9)* <0.01
Day 3 3.5 (0.9) 0.7 (0.6)* 1.2 (0.5)* 1.7 (0.4)* 0.2 (0.1)* 0.5 (0.2)* <0.01
Day 7 0.7 (0.4) 0.1 (0.2)* 0.1 (0.1)* 0.5 (0.3) 0* 0.1 (0.01)* <0.01
Pain (VAS)
Day 1 7.0 (2) 3.2 (3)* 2.9 (2.7)* 3.0 (2.6)* 1.3 (1)* 1.4 (1.1)* 0.002
Day 3 4.5 (2.1) 1.1 (2)* 1.4 (2.3)* 1.7 (1.6)* 0.2 (0.2)* 0.5 (0.9)* 0.002
Day 7 1.6 (2.5) 0.2 (0.6)* 0.2 (0.6)* 0.2 (0.3)* 0* 0* 0.02
Trismus (mm) ‡
Day 1 22.9 (8.8) 14 (9)* 11.5 (9)* 13 (7)* 13 (9)* 14.4 (8)* 0.016
Day 3 17.8 (11) 10 (8.4)* 8.6 (8.4)* 8 (3.6)* 8.2 (5)* 7.8 (3.5)* 0.005
Day 7 11.3 (9) 4.8 (4.2)* 5.2 (7)* 4 (3)* 4.5 (3)* 3.3 (3)* 0.021
No. of tablets 3.75 (3) 2.2 (2.1)* 1.6 (1.4)* 2.7 (2) 1.2 (0.8)* 0.75 (0.6)* <0.01
Social 1 (0) 0.25 (0.1)* 0.5 (0.3)* 0.4 (0.2)* 0.3 (0.1)* 0.5 (0.1)* <0.001
Eating 9.5 (2.7) 7.1 (3.4)* 4.8 (2.2)* 5.1 (3)* 4.7 (2.2)* 5.3 (2.3)* <0.001
Speech 3.5 (2.5) 1.7 (2)* 1.1 (1.7)* 0.5 (0.8)* 0.9 (1.2)* 0.6 (0.9)* <0.001
Sleep 2.7 (1.7) 0.8 (1.2)* 0.8 (1.3)* 0.8 (0.8)* 0.75 (1.5)* 0.75 (0.7)* 0.002
Appearance 2.3 (0.9) 0.8 (1.1)* 1 (0.7)* 0.5 (0.6)* 0.3 (0.4)* 0.7 (0.6)* <0.001
Total 19 (2) 9.5 (2.5)* 8.4 (3.1)* 9.2 (3.2)* 7.8 (4.2)* 9.4 (3)* <0.001
Table 4 Comparison of duration (in days) of effect on QOL among study groups
Social 3 (0.7) 0.5 (0.9)* 0.8 (0.9)* 0.8 (0.9)* 0.8 (1.2)* 1.3 (1.2)* <0.001
Eating 3.5 (0.5) 2.5 (1)* 2 (1.2)* 2.4 (1)* 2.3 (1.2)* 2.4 (1)* 0.028
Speech 2.3 (1.7) 1.3 (1.5) 0.4 (0.5)* 0.5 (0.8)* 1 (1.2)* 0.6 (0.9)* 0.003
Sleep 1.7 (1.2) 0.75 (1) 0.7 (0.7)* 0.9 (0.9) 0.6 (1.1)* 1.25 (1.4) 0.146
Appearance 3.5 (0.9) 1.3 (1.4)* 2 (1.4) 1 (1.5)* 0.6 (1.1)* 1.3 (1.4) <0.001
Total 2.8 (1.5) 1.27 (1) 1.18 (0.7)* 1.1 (0.7)* 1.06 (1.2)* 1.37 (1.1) 0.004
Using some carriers to apply the drug may solve this Methods used for measuring trismus and pain are also
procedural problem and should be considered in future universally accepted which enables making a logical
studies. comparison among different studies.
Swelling was evaluated by measuring linear facial
distances: a non-invasive, simple, cost-effective and
Post-operative sequelae in the control cases
time-saving method, which provides numeric data for
determination of soft-tissue changes. In addition, this The profile changes in swelling, pain and trismus in the
method was reported in many previous studies21,25,26. control group were classical to those reported in the
dexamethasone groups showed a significant reduc- absorption and without further surgical manipulation
tion in swelling, pain and trismus during the first of tissues. This timing also allows the surgeon to
post-operative week when compared to controls. accurately assess the need for steroid injection
Moreover, local application of dexamethasone according to post-operatively recorded surgical diffi-
showed more swelling reduction, though not signifi- culty and duration of intervention.
cant, than the oral route, but exhibited less effect than
intravenous and intramuscular routes. Regarding
pain, both types of local application also showed References
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