Dr. Bhavik Miyani, Resident Doctor in Department of Oral & Maxillofacial Surgery, NPDCH, Visnagar.

1. #10TH JOURNAL CLUB
PRESENTATION
Presented by,
Dr. Bhavik Miyani,
2nd Year PG,
Department of OMFS.
Guided by,
Dr. Anil Managutti,
Dr. Shailesh Menat,
Dr. Rushit Patel,
Dr. Jigar Patel

2. THE CLINICAL AND RADIOGRAPHICAL CHARACTERISTICS OF ZYGOMATIC COMPLEX
FRACTURES: A COMPARISON BETWEEN THE SURGICALLY AND NON-SURGICALLY
TREATED PATIENTS
Erik G. Salentijn , Jolanda Boverhoff , Martijn W. Heymans , Bart van den Bergh, Tymour Forouzanfar ,
Department of Oral and Maxillofacial Surgery/Oral Pathology (Head: Tymour Forouzanfar, MD, DDS, PhD), VU
University Medical Center,
Academic Centre for Dentistry Amsterdam (ACTA), P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands
Department of Epidemiology and Biostatistics, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The
Netherlands
2
Journal of Cranio-Maxillo-Facial Surgery 42 (2014) 492e497

3. 3
Keywords: Zygomatic Fracture, Trauma Treatment, Surgical, Non-surgical.
Background: In this retrospective study we evaluated the epidemiological data and the clinical and radiographical
differences between surgically and non-surgically treated patients with zygomatic complex fractures at their initial
assessment in our clinic over a period of 5 years.
Methods: Surgically and non-surgically treated patients were included in the study, if clinical and radiographical
confirmation of zygomatic complex fractures were present at initial assessment. The patient groups were divided into
surgically treated zygomatic complex fractures, and non-surgically treated fractures, with and without displacement.
The groups were compared according to age, gender, degree of fracture displacement and clinical signs.
Results: In total 283 patients were diagnosed with zygomatic complex fractures, with a mean age of 43 years (20
years) and a domination of male patients. The mean age was higher in the non-surgically treated group and contained
more female patients. Overall type C fractures and the majority of the type B fractures were treated surgically.
Conclusion: Extraoral steps, intraoral steps, and malar depression were significantly related to surgical treatment.
The group of non-surgically treated zygomatic complex fractures is a valuable group to investigate as this group also
consists of patients with displaced fractures (i.e. surgical indication) and thus, could provide us more insight in future
clinical decision methods. Therefore, we highly recommend more research of the non-surgically treated group.

4. INTRODUCTION
• Fractures of the zygomatic complex are commonly seen after facial trauma and are
frequently associated with additional traumatic injury.
• Early diagnosis of these fractures is essential for optimal treatment and is directly
dependent on appropriate initial evaluation, correct injury assessment and timely
initiation of the chosen therapy.
• Displacement of zygomatic complex fractures is in principle a surgical indication, unless
there is clinical contradictory, such as being medically unfit for surgery, patient refusal or
the absence of functional and/or aesthetic problems.
• However, a suspected and/or displaced zygomatic complex fracture could be easily
missed clinically at the initial assessment, due to the additional associated symptoms of
the trauma injury, such as facial swelling.
• Subsequently, computed tomography is routinely used to determine zygomatic complex
fractures and their potential displacement, but this radiographic examination is
‘supersensitive’: showing minor zygomatic complex fractures that are clinically not
relevant.
4

5. • An important aspect of a treatment protocol concerns the decision making, whether or not to treat
a patient surgically or non-surgically in case of a zygomatic complex fracture.
• This decision is based on clinical signs and radiographic analysis.
• The absence of knowledge of the similarities and differences of the clinical characteristics of
zygomatic complex fractures could hamper the development of any future clinical decision
making in treatment methods or even to distinguish patients benefiting from a surgical treatment.
• Literature of the preoperative assessment and in particular the clinical differences between
the surgically and non-surgically indicated treatment groups is lacking.
5

6. AIM OF THE STUDY
• The aim of the present study was to investigate the clinical characteristics of the surgically and
non-surgically treated patients with zygomatic complex fractures in our department.
• Thereby, we attempted to provide physicians a more complete view of the clinical presentation of
patients with fractures of the zygomatic complex.
6

7. MATERIAL AND METHODS
 STUDY DESIGN:
• A randomized, triple-blind, clinical trial was carried out with a split-mouth design.
• This study received human research ethics committee approval and was conducted
in accordance with the Consolidated Standards of Reporting Trials (CONSORT)
statement.
• Each patient signed a statement of informed consent prior to inclusion in the study.
• The trial is registered at clinical trials.gov number NCT01603498.
7

8. SAMPLE SIZE CALCULATION AND PILOT
STUDY
• Considering a 95% confidence level, the sample size was calculated based on each
dependent variable analyzed (pain, swelling, and trismus).
• The parameters used to perform the sample size calculation were obtained from a
pilot study involving four patients.
• The estimate for the comparison of repeated quantitative measurements was used
for pain, trismus, and swelling.
• A minimum of 16 patients was determined, to which 10% was added to compensate
for possible losses, resulting in a total of 18 participants.
• The patients who participated in the pilot study were not included in the main study.
8

9. 9

10. 10

11. 11

12. 12

13. 13

14. 14

15. 15

16. SAMPLE SELECTION, MASKING, AND
RANDOMIZATION
o Eighteen healthy subjects aged 18–25 years were selected to participate in the
study, which was carried out at the university oral surgery clinic.
The inclusion criteria were an orthodontic indication for bilateral extraction of
impacted mandibular third molars and similar surgical difficulty between sides
(Class II position B) based on the Pell and Gregory classifica-tion,17 assessed by
clinical and radio-graphic examinations.
The following were exclusion criteria:
• use of an anti-inflammatory agent or analgesic other than those being tested during
the study or within 15 days prior to the beginning of the study;
• hypersensitivity to the drugs or other substances employed in the study;
• pregnancy or lactation.
16

17. • To ensure that the patient, principal investigator, surgeon, and statistician were
unaware of which medication was administered at each surgery, the corticosteroid
capsules were of the same colour and size, were stored in similar bottles, and were
coded as drug 1 or drug 2 by a specialized compounding pharmacy (Pharmacy
Manipulation Amphora).
• The randomization procedure was performed by a researcher not directly involved
in the evaluation of the patients and surgeries, using sequentially numbered sealed
envelopes. Each envelope had the combination (obtained by means of a draw) of
the drug to be administered (drug 1 or drug 2) and the side of the surgery (right or
left). For each patient enrolled, the researcher opened the envelope, informed the
principal investigator and surgeon of the side to be operated on and gave the drug
to the patient 1 h prior to surgery. The second surgical procedure was performed on
the contralateral side, with the administration of the second drug 1 h prior to
surgery.
• Thus, the patient, surgeon, and principal investigator responsible for the
assessments of swelling and trismus were masked to the type of medication used
during each surgical procedure.
17

18. SURGICAL PROCEDURES AND
MEDICATIONS
• One hour prior to each procedure, the patients received a single oral dose of either
dexamethasone 8 mg or methylprednisolone 40 mg.
• Each patient underwent two surgical extractions (performed in the morning)
separated by a period of 3– 4 weeks and conducted by the same experienced
surgeon.
• Prior to surgery, the patients were submitted to extraoral antisepsis with an alcohol
solution of 10% povidone–iodine (PVP-I). Local anaesthesia was performed with
lidocaine 2% and epinephrine 1:100,000, employing a maximum volume of 5.4 ml. A
standardized technique was used for all surgeries.
• First, an incision was made on the alveolar ridge from distal to mesial on the
mandibular branch to reach the distolingual region of the second molar, followed by
an intrasulcular incision encircling the second molar to the region of the interdental
papilla between the second and first molar.
18

19. • The mucoperiosteal flap was raised and an ostectomy was performed. The tooth
was sectioned and removed with the aid of straight Seldin elevators, followed by
careful curettage, bone regularization, and cleaning of the surgical cavity with
copious irrigation using saline solution.
• The flap was sutured with four interrupted stitches using silk thread 4.0. The
duration of surgery was recorded in minutes, from the time of the initial incision to
the time of the final suture.
19

20. POSTOPERATIVE MANAGEMENT
• After all surgeries, patients received instructions regarding local haemostatic
measures, feeding, cleaning of the operated region, and the restriction of physical
exertion, and other routine postoperative recommendations.
• The patients were given instructions to take one tablet of paracetamol
(acetaminophen) 750 mg immediately following surgery and every 6 h thereafter, as
required, for a maximum of 3 days, for the control of pain.
20

21. CLINICAL PARAMETERS
• After each surgery, the patient was asked to indicate the intensity of pain on a 10- point
numerical rating scale. To facilitate the patient’s understanding, the scale dis-played different
colours and a face scale with images of different expressions.
• The following categorization was used: 0–2 points = mild pain; 3–7 points = moderate pain;
and 8–10 points = severe pain. Pain was assessed at 8-h intervals during the first 72 h of the
postoperative period.
• The patients were also instructed to record the number of rescue drugs consumed by the
seventh postoperative day. Swelling was evaluated with the aid of a tape measure.
• Three measurements were performed on the patient using five reference points: (A) corner
of the eye/angle of the mandible; (B) tragus/corner of the mouth; (C) tragus/pogonion. The
evaluations were carried out in the preoperative period (baseline) as well as at 24, 48, and
72 h and 7 days following surgery. The evolution of swelling was evaluated by subtracting
the total value obtained at each postoperative period (sum of the three measurements) by
the sum obtained at baseline.
21

22. • Limited mouth opening (trismus) was assessed by determining maximal unassisted
mouth opening, measured with a simple calliper between the left upper and lower
central incisors.
• This distance was determined in the preoperative period (baseline) as well as at 24,
48, and 72 h and 7 days postoperatively. Limited mouth opening was determined by
the difference between the preoperative period and each postoperative period.
• The measurements for the evaluation of swelling and trismus were performed by a
single trained, calibrated examiner.
22

23. STATISTICAL ANALYSIS
• Data analysis was performed using the Statistical Package for Social Sciences
(SPSS for Windows, version 17.0; SPSS Inc., Chicago, IL, USA) and included
descriptive statistics and association tests for comparisons between protocols
(dexamethasone and methylprednisolone).
• The Shapiro–Wilk test was used to evaluate the distribution of the data (normal or
non-normal), followed by the application of parametric or non-parametric tests,
when appropriate.
• The Wilcoxon test for paired samples was used to compare the duration of surgery
and number of analgesics consumed postoperatively in the two groups.
• Regarding pain, swelling, and trismus, the Wilcoxon test for paired samples was
used when the data were not normally distributed and the paired t-test was used
when the data were normally distributed.
23

24. RESULTS
• The present study was carried out between March and November 2011.
• Eighteen patients were initially selected. However, two did not participate in all
postoperative stages. Losses were due to the fact that one patient only underwent
one of the surgeries (treated with methylprednisolone) and moved to another city
and another patient (treated with dexamethasone) self-medicated with a non-
steroidal anti inflammatory drug in the postoperative period and abandoned follow-
up to undergo an additional surgery.
• Thus, 16 patients (3 men and 13 women; mean age 20.3 years, standard deviation
1.25 years) participated in all stages of the study.
• There were no cases of postoperative complications or adverse reactions to the
drugs used.
• No statistically significant differences between groups were found regarding the
duration of surgery or number of analgesic tablets consumed in the postoperative
period (Table 1).
24

25. 25

26. 26

27. • With both pre-emptive drugs, peak swelling occurred at 48 h postoperatively, with
facial contours returning to normal on the seventh day. Statistically significant
differences between protocols were found at all postoperative evaluation times.
Patients experienced less swelling following surgeries in which pre-emptive
dexamethasone was employed (Table 2).
27

28. • A reduction in mouth opening occurred in all postoperative periods, regardless of
the type of drug used. However, this reduction was more accentuated following
surgery in which pre-emptive methylprednisolone was employed. The difference
between protocols was statistically significant (P = 0.029) at the 48-h evaluation,
with a mean of 5.56 mm lesser mouth opening following the pre-emptive use of
methylprednisolone in comparison to dexamethasone (Table 3).
28

29. • No statistically significant differences were found between protocols with regard to
postoperative pain (P > 0.05). How-ever, at all the postoperative evaluation times
patients indicated lower pain scores following surgery with the pre-emptive use of
dexamethasone in comparison to methylprednisolone (Fig. 2).
29

30. DISCUSSION
• The literature offers a number of studies on the analgesic and anti-inflammatory
effects of different doses and routes of administration of either methylprednisolone
or dexamethasone.
• However, no comparative analyses were found regarding the efficacy of
corticosteroids with different potencies and degrees of duration of anti-inflammatory
action in the control of postoperative complications following the extraction of third
molars.
• To the best of our knowledge, the present prospective investigation is the first to
compare two types of corticosteroid – one with long-lasting action (dexamethasone)
and one with medium-length action (methylprednisolone) – administered orally in a
single preoperative dose.
• Thus, the comparison of the results of this investigation with findings reported in the
literature is limited by the considerable methodological variations found among
studies.

31. • Pell and Gregory classification has been questioned as an appropriate method for
determining the complexity of third molar extractions, one well-controlled clinical trial
found that the radiographic position of impacted teeth could be a good indicator of
surgical difficulty.
• In the present study, the patients were operated on by the same surgical team and
had their teeth in the same radiographic position. Further-more, to eliminate
variations in the inflammatory response resulting from individual differences, the
split-mouth design was employed, in which each patient served as his/her own
control.
31

32. • The duration of surgery and number of rescue analgesics consumed by the patients
were evaluated for the control of possible confounding factors that could influence
responses regarding the three variables studied (swelling, trismus, and pain). As no
statistically significant differences were found between protocols.
32

33. • Facial swelling occurs in response to the considerable trauma to the tissues in the
third molar region.
• Onset is gradual, with peak swelling 48 h after surgery. However, some authors
have reported that swelling can increase on the third day following surgery.
• Thus, swelling was also evaluated after 72 h in the pre-sent study. Dexamethasone
proved more effective in controlling swelling than methylprednisolone at all
postoperative evaluation times.
• This finding may be explained by the fact that dexamethasone has a longer duration
of action and greater potency in comparison to methylprednisolone.
33

34. • Trismus is also a common complication following third molar extraction and can
have a negative impact on quality of life by hampering eating and speaking.
• Lesser limited mouth opening in the post-operative period was observed with the
use of dexamethasone. However, the difference between drugs was only significant
on the second day of evaluation. This finding may be explained by the biological
half-life of the drugs, as dexamethasone is considered a long-acting steroid (36–54
h) and methylprednisolone has intermediate action (18–36 h)
34

35. CONCLUSION
• The results of the present study indicate that the preoperative administration of 8
mg of dexamethasone achieves better control of swelling and limited mouth opening
than methylprednisolone at a dose of 40 mg, with no differences between drugs
regarding pain control.
35

36. THANK YOU
42