PEDIATRIC/CRANIOFACIAL

Cleft Maxillary Distraction versus Orthognathic

Surgery: Clinical Morbidities and
Surgical Relapse
Lim Kwong Cheung, B.D.S.,
F.C.D.S.H.K.(O.M.S.), Ph.D.
Hannah Daile P. Chua,
D.D.M., M.A., M.D.S.
Margareta Bendeus Hägg,
D.D.S., Cert. Comp. Orth.,
F.C.D.S.H.K.(Orthod.)
Hong Kong SAR, China
Background: This is the first randomized controlled study aiming to compare
the postoperative clinical morbidities in cleft lip and palate patients treated with
distraction osteogenesis versus conventional orthognathic surgery.
Methods: Twenty-nine cleft lip and palate patients with moderate maxillary
hypoplasia requiring a maxillary Le Fort I advancement of 4 to 10 mm were
randomized into two groups for either internal maxillary distractors or imme-
diate fragment transposition using miniplates and screw fixation. Clinical mor-
bidities were recorded using standardized questionnaires. Skeletal and dental
relapses were assessed using lateral cephalometric landmarks.
Results: In the distraction group, two of 15 patients developed infection around
the distractors and one patient had an occlusal relapse. Among the 14 patients
who received conventional orthognathic surgery, the complications included
intraoperative hemorrhage (n ⫽ 1), plate exposure leading to sinusitis (n ⫽ 1),
and occlusal relapse (n ⫽ 1). In the skeletal relapses of the osteotomy group,
a statistically significant vertical relapse of the A point was noted during the
second to twelfth weeks when compared with the distraction group. A statistically
significant horizontal relapse of the A and P points during the eighth to twelfth
weeks was noted when the osteotomy group was compared with the distraction
group.
Conclusions: There were no major differences in the clinical morbidities be-
tween the osteotomy and distraction groups. Distraction provided better skeletal
stability, whereas there was a significant amount of skeletal relapse in the first
12 weeks after conventional cleft maxillary osteotomy. (Plast. Reconstr. Surg.
118: 996, 2006.)

D
istraction osteogenesis involves the regen-
eration of bone through gradual traction
between two surgically separated frag-
ments fixed to a mechanical device. This tech-
nique was pioneered by orthopedic surgeons in
the late 1880s and was first described by the
Italian practitioner Codivilla in 1905. In 1954,
the Russian orthopedic surgeon Dr. Gavriel Il-
izarov undertook the first scientific studies of the
distraction of long bones.1
Distraction osteogenesis was first applied to
the maxillofacial complex in 1972, when Snyder
et al. 2 used an external fixation device to
From the Disciplines of Oral and Maxillofacial Surgery and
Orthodontics, Faculty of Dentistry, The University of Hong
Kong.
Received for publication March 25, 2005; accepted April 22,
2005.
Copyright ©2006 by the American Society of Plastic Surgeons
DOI: 10.1097/01.prs.0000232358.31321.ea
lengthen a canine mandible. In 1976, Michieli
and Miotti3 reproduced Snyder’s work using an
intraoral device. These studies prompted a de-
tailed histological analysis of the ossification pro-
cess following mandibular distraction in a canine
model.4 This laboratory work paved the way for
the first human mandibular distraction in 1989.
After the advent of mandibular distraction, lab-
oratory studies were conducted to investigate the
efficacy of distraction osteogenesis in other re-
gions of the craniofacial skeleton.
Cohen et al.5 devised a miniature distraction
system for the midface in 1995. This device per-
mitted maxillary and midfacial advancement in
young children with cleft lip and palate or
craniofacial syndromes. They reported that this
device produced no complications. Distraction
to correct severe midfacial hypoplasia in chil-
dren allows early intervention with a potentially
less invasive technique.6 Polley and Figueroa7
applied rigid external distractors to 18 cleft lip

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Volume 118, Number 4 • Cleft Distraction versus Orthognathic Surgery
and palate patients. Swennen et al.8 reported on
the performance of similar maxillary distraction
in cleft lip and palate patients using anterior
traction with a Delaire facial mask.
Secondary cleft lip and palate deformities
have traditionally been corrected using orthog-
nathic surgery, by advancing the hypoplastic
maxilla to the normal position in relation to the
skull and the occlusion. However, it is technically
more difficult to perform immediate transposi-
tion of the cleft maxilla than the noncleft max-
illa, and there is also a greater chance of subse-
quent skeletal and occlusal relapse.9 Additional
possible problems with cleft maxillary osteoto-
mies include prolonged healing, postoperative
infection, and vascular ischemia leading to loss
of teeth, bone, and soft tissues.10 Welch11 con-
cluded that Le Fort I advancement in cleft lip
and palate patients was extremely unstable be-
cause of scarring. The surgery, method of fixa-
tion, neuromuscular adaptation, and orthodon-
tics can also contribute to the likelihood of
relapse.
To the best of our knowledge, this is the first
randomized controlled study of distraction in
cleft lip and palate cases. We hypothesized that
distraction osteogenesis would result in fewer
surgical relapses than conventional orthognathic
surgery, because the gradual traction by distrac-
tion may overcome the tension of the cleft pal-
atal scar. We also hypothesized that the postsur-
gical morbidities of distraction would be higher
than in conventional orthognathic surgery be-
cause of the prolonged retention of the distrac-
tors. This study, therefore, aims to compare the
postoperative clinical morbidities in two groups
of cleft lip and palate patients, one treated with
distraction osteogenesis and the other with con-
ventional orthognathic surgery.
PATIENTS AND METHODS
Eligible subjects were cleft lip and palate
patients presenting with moderate maxillary hy-
poplasia and needing Le Fort I osteotomy. Pa-
tients were aged 16 years or older with mature
skeletal growth (i.e., complete bone fusion of
the radial epiphysis confirmed by radiography).
The maxillary alveolar clefts should have been
grafted and undergone presurgical arch align-
ment using orthodontics under the supervision
of the last author (M.B.H.) at the University
Cleft Lip and Palate Center of the University of
Hong Kong. All patients underwent a standard
surgical assessment, dental model surgery, and
prediction tracing. Patients who required max-
illary advancement ranging from 4 to 10 mm
(based on the model surgery) were included in
the study. Syndromic patients and patients who
presented with systemic diseases were excluded.
Patients who required maxillary advancement of
more than 10 mm were treated by distraction
osteogenesis, and those who needed advance-
ment of less than 4 mm were treated using con-
ventional orthognathic surgery. These latter two
groups were excluded from the study. Patients
who satisfied the inclusion criteria were ran-
domly assigned to one of two groups, treatment
either by distraction with internal distractors or
by conventional osteotomy. A senior investiga-
tor (L.K.C.) with extensive experience in both
distraction and orthognathic surgery performed
the assessment and was in charge of patient
randomization, which was done using a table of
random numbers.12
The study was approved by the faculty ethics
committee, and all patients involved in the study
provided written consent. The operations were
performed between June of 2002 and July of 2004
in the faculty’s Discipline of Oral and Maxillofacial
Surgery department.
Surgical Technique
A standardized Le Fort I osteotomy with or
without segmentalization was performed on the
cleft maxilla with the patient under general anes-
thesia. The conventional Le Fort I osteotomy was
fully mobilized to the preplanned position in line
with the model surgery and guided by a surgical
splint. The mobilized maxilla was fixed with two
titanium miniplates on each side at the zygomatic
buttress and the pyriform region (Fig. 1). Inter-
maxillary fixation was removed immediately. On
the other hand, the Le Fort I osteotomy for dis-
traction was only mobilized to a limited extent,
without achieving the final surgical position. The
distractors were oriented according to a custom-
made vector guidance splint. This vector guidance
splint was constructed beforehand based on the
simulated model surgery demonstrating transpo-
sition of the maxillary model from the original to
the planned position. An occlusal splint, with a
wire embedded in the molar area, indicated the
vector required for the maxillary transposition.
The occlusal splint was fixed between the mandi-
ble and the mobilized maxilla. The direction of
the embedded wire indicated the required orien-
tation of the internal maxillary distractor. Fixation
of the zygoma and the molar alveolus was achieved
with an intraoral bone-borne maxillary distractor
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 Plastic and Reconstructive Surgery • September 15, 2006

Fig. 1. Conventional cleft Le Fort I osteotomy with miniplate fixation. (Above, left) A standard lateral osteotomy cut was made at the
Le Fort I level. (Above, right) The maxilla was mobilized by downfracturing. (Below, left) Fixation was achieved using two titanium
miniplates and screws on the pyriform rims and zygomatic buttresses. (Below, right) Elastic traction was applied to control the
occlusion in the early postoperative period.

(Synthes, West Chester, Pa.) on each side (Fig. 2).
After a latency of 3 days, activation was com-
menced at 1 mm per day in two rhythms until a
class I incisal relationship was achieved. One tita-
nium microscrew was inserted at the mesial root
apex of the upper first molar, and one was inserted
at the incisal A point in both groups. These mi-
croscrews were used as radiographic markers for
the evaluation of the maxillary skeletal relapse.
Light orthodontic traction was used to control the
occlusion in the early postoperative period in both
groups.
Simultaneous mandibular operations were
performed if indicated (Tables 1 and 2). All the
mandibular osteotomies were stabilized with tita-
nium miniplate fixation. Standardized question-
naires were used to record the clinical morbidities
either during the operation or postoperatively.
The patients were reviewed at regular postopera-
tive intervals of 2 and 8 weeks and 3, 6, and 12
months.
Lateral Cephalometric Assessment
Standardized lateral cephalographs were
taken of all patients both shortly before the op-
eration and postoperatively at 2 and 8 weeks and
at 3, 6, and 12 months. These radiographs were
used to analyze skeletal relapse. The method of
analysis was a modification advocated by Cheung
et al.13 (Fig. 3). A line was drawn from the sella (S)
to the nasion (N), and a horizontal reference
plane was taken at 7 degrees from SN. Several
landmarks were identified, including the sella, na-
sion, microscrewed A point (A), and posterior
maxillary point (P). A vertical line perpendicular
to the horizontal reference line dropped from the
S point was used.
Measurements that indicated the changes and
stability in the position of the maxilla were the
horizontal and vertical movement of A point (A)
and the horizontal and vertical movement of the
microscrew at the first molar region (P).
All tracings were superimposed using the sella,
nasion, and cranial base structures, utilizing a
method of anatomic best fit.19 The lateral cepha-
lographs were taken using the same machine
(Philips Orthoralix SD, Monza, Italy) and traced
manually. The movements of the landmarks were
measured using an electronic digital caliper (Digit
Cal, Tesa, Switzerland) down to two decimal
points. Each reading was taken three times and the
mean was documented. All measurement data
were processed on personal computers and ana-
lyzed using Statistical Package for Social Science
software (SPSS 11.5; SPSS Inc., Cary, N.C.). The
relapses in the horizontal and vertical directions in

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Fig. 2. Cleft distraction with internal maxillary distractors. (Above, left) In adaptation of an intraoral borne maxillary distractor, the
planned osteotomy cut was marked out to allow clearance of the distractors. (Above, right) Lateral osteotomy at the Le Fort I level was
completed anteriorly through the pyriform rim and posteriorly to reach the pterygomaxillary junction. (Below, left) The intraoral
borne distractor was reattached and fixed on each side of the maxilla with miniscrews. (Below, right) An activation screwdriver was
used to confirm the feasibility of activating the distractors.

the different time periods were compared using ability of the differences. Dahlberg’s formula14
the Student t test at a statistical significance level was used to determine the random error:
of 5 percent.

Reliability Test
Twenty lateral cephalographs were ran-
domly selected from 20 patients. Landmark
identification and tracings were performed
manually. The microscrewed A-point (A) and
the posterior maxillary point (P) were mea-
sured using an electronic digital caliper (Digit
Cal) in relation to the horizontal and vertical
reference lines. Reading was taken and docu-
mented. The same process was repeated by the
same author 1 week later. Reliability and error
analysis tests from the two sets of measurement
were performed. Reliability was confirmed by
paired t test with a 5 percent level of signifi-
cance (SPSS). The random error is of relevance
because it determines the metric differences
between the two measurements and the accept-
RE ⫽
2n 冑 兺 d2
with RE ⫽ random error, n ⫽ sample size, and d
⫽ difference between the two instruments
The reliability analysis using paired t tests
showed no significant difference between two trac-
ings carried out on separate occasions (Table 3).
The random error confirmed a small differ-
ence, but it was within the clinically acceptable
limit (Table 4).
RESULTS
Fifteen of the 29 patients who participated in
the study underwent distraction with internal max-
illary distractors, while the other 14 had conven-
tional osteotomies. Distraction osteogenesis and
conventional orthognathic surgery patients are
shown in Figures 4 through 7. For the distraction

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 Plastic and Reconstructive Surgery • September 15, 2006

Table 1. Patient Profile of the Maxillary Distraction Group and Associated Clinical Morbidities* (n ⴝ 15)
Maxillary Follow-Up
Type of Advancement Period Clinical
Case No. Sex Cleft Surgery Performed (mm) (months) Morbidities
1 F UCLP Le Fort I DOG 8 24 Occlusal relapse
2 F UCLP Le Fort I DOG 7 24 –
3 F UCLP Le Fort I DOG ⫹ genioplasty 4 24 –
4 F UCLP Le Fort I DOG ⫹ AMS 7 22 –
5 F UCLP Le Fort I DOG ⫹ AMS 7 21 –
6 M BCLP Le Fort I DOG 8 19 Mucosal infection
7 M UCLP Le Fort I DOG ⫹ AMS 10 7 –
8 F UCLP Le Fort I DOG 10 7 –
9 M BCLP Le Fort I DOG ⫹ AMS 7 7 –
10 F CP Le Fort I DOG ⫹ AMS 6 7 Mucosal infection
11 F UCLP Le Fort I DOG ⫹ BSSO 5 13 –
12 M UCLP Le Fort I DOG ⫹ AMS 4 12 –
13 F CP Le Fort I DOG ⫹ AMS 5 6 –
14 M UCLP Le Fort I DOG ⫹ AMS ⫹ BVSO 6 6 –
15 M BCLP Le Fort I DOG 6 4 –
UCLP, unilateral cleft lip and palate; BCLP, bilateral cleft lip and palate; CP, cleft palate; DOG, distraction osteogenesis; AMS, anterior
mandibular subapical osteotomy; BSSO, bilateral sagittal split osteotomy; BVSO, bilateral vertical subsigmoid osteotomy.
*Maxillary advancement was measured based on the planned model surgery. The mean advancement was 6.7 mm (SD, 1.89 mm).

group, the mean advancement of the maxilla was
6.7 mm (SD, 1.89) (Figs. 4 and 5). For the osteot-
omy group, the maxilla was advanced a mean dis-
tance of 5.3 mm (SD, 1.60) (Figs. 6 and 7). There
was no statistically significant difference in the
surgical movement between the two groups (p ⫽
0.0543). The surgical movements, surgical tech-
nique, and cleft lip and palate deformities of the
patients shown in Figures 4 through 7 are tabu-
lated in Tables 1 and 2.
Serial superimposition of the lateral cepha-
lographs taken at each time period revealed
that the surgically advanced maxilla relapsed
(backward movement) in the osteotomy group
but advanced (forward movement) in the dis-
traction group (Tables 5 and 6). The surgical
movement and relapse at each time period
were compared. The statistically significant re-
sults between the two groups (p ⬍ 0.05) are
highlighted in Tables 5 and 6 and are further
elaborated below.
The mean vertical relapse (upward move-
ment) of the conventional osteotomy group at A
point was 6 percent in the second to eighth week
and 33 percent in the eighth to twelfth week,
whereas in the distraction group there was further

Table 2. Patient Profile of the Maxillary Osteotomy Group and Associated Clinical Morbidities* (n ⴝ 14)
Maxillary Follow-Up
Case Type of Advancement Period Clinical
No. Sex Cleft Surgery Performed (mm) (months) Morbidities
1 M UCLP Le Fort I ⫹ AMS 4 25 –
2 M BCLP Le Fort I ⫹ AMS 4 24 –
3 F UCLP Le Fort I ⫹ AMS 4 24 –
4 M UCLP Le Fort I ⫹ AMS 5 18 –
5 M UCLP Le Fort I ⫹ AMS 5 17 –
6 M BCLP Le Fort I ⫹ AMS 5 13 –
7 F UCLP Le Fort I ⫹ AMS 8 17 Occlusal relapse
8 M UCLP Le Fort I ⫹ AMS 4 16 Sinusitis, infection due to plates
and screws
9 F UCLP Le Fort I ⫹ AMS left SSO ⫹ 8.5 12 –
right VSO
10 M BCLP Le Fort I ⫹ AMS 4.5 10 Transection of right descending
palatine vessel
11 M BCLP Le Fort I ⫹ AMS 6.5 7 –
12 M CP Le Fort I ⫹ AMS 4 18 –
13 F UCLP Le Fort I ⫹ BVSO 6.5 5 –
14 F BCLP Le Fort I ⫹ AMS ⫹ BVSO 5 2 –
UCLP, unilateral cleft lip and palate; BCLP, bilateral cleft lip and palate; CP, cleft palate; AMS, anterior mandibular subapical osteotomy; SSO,
sagittal split osteotomy; (B)VSO, (bilateral) vertical subsigmoid osteotomy.
*Maxillary advancement was measured based on the planned model surgery. The mean advancement was 5.3 mm (SD, 1.60 mm).

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Table 4. Error Analysis of Lateral Cephalometric

Analysis Using Dahlberg’s Formula (n ⴝ 20)
Maxillary Landmark d2 Random Error
A point to x 32.75 0.90 mm
P point to x 15.25 0.26 mm
A point to y 2.75 0.62 mm
P point to y 19.75 0.70 mm
x, horizontal reference line; y, vertical reference line; d, difference
between the two measurements.

class III edge-to-edge malocclusion 3 months post-

Fig. 3. Reference lines and landmarks used for the cephalomet-
ric analysis of stability evaluation: S, sella; N, nasion; A, subspinale
A point; P, microscrew above the mesial root of the upper first
molar.
downward movement of 15 percent and 10 per-
cent, respectively, during the same periods (p ⫽
0.032; p ⫽ 0.024). In the horizontal movement of
the conventional osteotomy group at A point and
P point, relapse (backward movement) of 21 per-
cent and 13 percent was noted during the eighth
to twelfth weeks after osteotomy. In contrast, fur-
ther forward movement of 25 percent and 15 per-
cent was recorded in the distraction group (p ⫽
0.017; p ⫽ 0.039). Student’s t test showed a statis-
tically significant difference (p ⬍ 0.05) between
the two groups at these periods.
In the osteotomy group (Table 2), one patient
experienced rupture of the right descending pal-
atine vessel during the operation. The vessel was
subsequently ligated to control the bleeding. Post-
operatively, the patient was monitored closely and
the healing was uneventful. One patient devel-
oped early clinical relapse of dental occlusion to
operatively. The occlusion was later compensated
for by orthodontics. Another patient had expo-
sure of one miniplate at the buccal sulcus region;
his condition was complicated by maxillary sinus-
itis (Fig. 8). He received antrostomy, and the
plates and screws were removed from the affected
site during the same operation; the complications
subsequently resolved.
In the distraction group (Table 1), two pa-
tients developed mucosal infection around the
distractors during the activation period. The in-
fection was controlled with intravenous antibiotics
administered for a week. One patient developed
early clinical relapse of dental occlusion to class III
malocclusion (overjet of ⫺4 mm) 2 months after
distraction surgery. This malocclusion was cor-
rected by repeating the Le Fort I osteotomy and
affixing the titanium miniplates and screws at the
distractor removal stage. However, at 8 weeks after
this second operation, the occlusion relapsed
again to class III malocclusion (overjet of ⫺2.5
mm). Compensation by orthodontics was at-
tempted, but the occlusal result was still consid-
ered unsatisfactory (overjet of ⫺1 mm, open bite
of 1.5 mm).
The possible causes of the complications and
relapse were further analyzed to explore the re-
lation to maxillary segmentalization. Nine of 29
cases required maxillary segmentalization. In the
distraction group, all the complications were in
the nonsegmentalized cases; the situation was sim-
ilar in the osteotomy group, with the exception of
the case of clinical occlusal relapse. The vertical
and horizontal relapse encountered in the con-
ventional osteotomy group was further analyzed to

Table 3. Reliability of Lateral Cephalometric Analysis Using Two-Tailed Paired t Test (nⴝ20)
Maxillary Landmark First Tracing Second Tracing Difference SD SEM p
A point to x 66.75 66.48 0.27 1.28 0.29 0.35
P point to x 50.22 50.30 ⫺0.75 0.37 0.20 0.38
A point to y 55.90 55.82 0.08 0.89 0.08 0.71
P point to y 56.32 56.25 0.07 1.01 0.23 0.74
x, horizontal reference line; y, vertical reference line.

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Fig. 4. Clinical changes in a patient undergoing distraction with an internal distractor.

(Aboveandcenter,left)Preoperativefrontalandlateralviews.(Aboveandcenter,right)Post-
operative frontal and lateral views. (Below, left) Preoperative lateral cephalograph. (Below,
right) Lateral cephalograph showing the distractor during the consolidation period.

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Fig. 5. Same patient as shown in Figure 4. (Left, above and below) Preoperative frontal and lateral occlusal views. (Right, above and
below) Postoperative frontal and lateral occlusal views.
determine the relationship to segmentalization as
a predisposing factor. Paired t test showed no sta-
tistical difference in the relapse rate between seg-
mentalized and nonsegmentalized Le Fort I os-
teotomy.
DISCUSSION
Surgeons face a challenge in correcting de-
formities in cleft lip and palate patients with severe
maxillary hypoplasia. The treatment planning and
operations are more complex in cleft patients
than in noncleft patients, because the required
amount of maxillary advancement is generally
quite large. Hence, orthognathic surgery is more
difficult to perform in cleft lip and palate cases,
and this naturally contributes to surgical relapse.
Most surgeons accept that advancement of more
than 10 mm is beyond the present limit of cleft
orthognathic surgery and can only be achieved by
distraction osteogenesis. On the other hand, sur-
gical advancement of less than 4 mm can be
achieved relatively easily with cleft orthognathic
surgery. The choice between orthognathic surgery
and distraction depends largely on the degree of
advancement of the maxilla required. This study
aimed to provide evidence-based data to clarify the
advantages and disadvantages of each treatment
method.
Different techniques of maxillary distrac-
tion osteogenesis have been developed, based
on the types of devices used. Distraction was
initially applied to the maxillofacial region us-
ing extraoral devices. Transcutaneous pins and
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Fig. 6. Clinical changes in a patient receiving conventional osteotomy. (Above and

center, left) Preoperative frontal and lateral views. (Above and center, right) Postoper-
ative frontal and lateral views. (Below, left) Preoperative lateral cephalograph. (Below,
right) Postoperative lateral cephalograph.

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Fig. 7. Same patient as shown in Figure 6. (Left, above and below) Preoperative frontal and lateral occlusal views. (Right, above and
below) Postoperative frontal and lateral occlusal views.

traction markings may leave lifetime residual
scarring.15 As with intraoral devices, both inser-
tion and removal require an operation and re-
tention of the device over a 3-month period.
This in turn lengthens the distraction treat-
ment. The activation arm of the device tends to
protrude into the oral cavity. This can produce
significant discomfort for patients. Mainte-
nance of oral hygiene and food intake also
cause patients some inconvenience.

Table 5. Mean Surgical Movement and Relapse of Cleft Maxillary Advancement by Distraction Based on Serial
Cephalometric Analyses (n ⴝ 15)
Horizontal Vertical Horizontal Vertical
Movement of Movement of Movement of Movement of
Postoperative Period A Point A Point P Point P Point
2–8 weeks (n ⫽ 15) ⫹0.7 mm, 10% ⫹1.0 mm,* 15% ⫹0.4 mm, 6% ⫹0.3 mm, 4%
8–12 weeks (n ⫽ 15) ⫹1.7 mm,* 25% ⫹0.7 mm,* 10% ⫹1.0 mm,* 15% ⫹0.7 mm, 10%
3–6 months (n ⫽ 15) ⫹0.7 mm, 10% ⫹1.3 mm, 19% ⫹0.5 mm, 7% ⫹0.5 mm, 7%
6–12 months (n ⫽ 12) ⫹0.6 mm, 9% ⫹0.3 mm, 4% ⫹0.5 mm, 7% ⫹0.3 mm, 4%
*p ⬍ 0.05 by Student t test of the same period between the conventional osteotomy and distraction groups (Table 5 versus Table 6). ⫹, further
maxillary forward movement.

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 Plastic and Reconstructive Surgery • September 15, 2006

Table 6. Surgical Movement and Relapse of Cleft Maxillary Advancement by Conventional Osteotomy Based
on Serial Cephalometric Analyses (n ⴝ 14)
Horizontal Vertical Horizontal Vertical
Movement of Movement of Movement of Movement of
Postoperative Period A Point A Point P Point P Point
2–8 weeks (n ⫽ 14) ⫺0.8 mm, 15% ⫺0.3 mm,* 6% ⫺0.6 mm, 12% ⫺0.1 mm, 2%
8–12 weeks (n ⫽ 13) ⫺1.1 mm,* 21% ⫺1.7 mm,* 33% ⫺0.7 mm,* 13% ⫺1.4 mm, 27%
3–6 months (n ⫽ 12) ⫺0.8 mm, 15% ⫺0.2 mm, 4% ⫺0.4 mm, 8% ⫺0.2 mm, 4%
6–12 months (n ⫽ 12) ⫺0.8 mm, 15% ⫺0.5 mm, 10% ⫺0.1 mm, 2% ⫺0.5 mm, 10%
*p ⬍ 0.05 by Student t test of the same period between the conventional osteotomy and distraction groups (Table 5 versus Table 6). ⫺, backward
maxillary movement (relapse).

There are differences in the indications be-
tween distraction and orthognathic surgery.16
The major difference is that the maxilla is slowly
advanced into the preoperatively planned oc-
clusion. This can overcome the soft-tissue ten-
sion and can correct large advancements be-
yond the normal capabilities of orthognathic
surgery. On the other hand, orthognathic sur-
gery can produce more precise control for cor-
rection of the occlusion than distraction can.
Although distraction is expanding its role in
maxillary transverse widening with the use of
palatal distraction, it cannot yet achieve three or
four pieces of segmentalization as seen with or-
thognathic surgery. Retrusion or impaction of
the maxilla is also only possible at present with
orthognathic surgery.
There have been few reports on the poten-
tial complications of distraction osteogenesis. A
similar range of morbidities and complications
associated with conventional orthognathic pro-
cedures may occur with distraction osteogene-
sis. In this study, two of the patients treated with
distraction developed mucosal infection around
the distractor rod. Since the rod penetrates the
mucosa in the mucobuccal fold, it is a portal of
entry for microorganisms that predispose the
patient to infection. Masticatory movement is a
compounding factor. Therefore, good hygiene
is very important for patients treated with dis-
traction via an intraoral approach. Intravenous
antibiotics are indicated to treat the infection,
and early removal of the distractors may be nec-
essary if the infection becomes persistent or re-
current. In a study performed by Kessler et al.,17
four patients also developed mucosal infection
at various times during the distraction process;
the infections were satisfactorily controlled by
antibiotics.
In this study, two patients (one from the
distraction group and the other from the os-
teotomy group) developed dental malocclusion

Fig. 8. Complication in a patient who underwent conventional osteotomy. (Left) One miniplate in the left buccal
sulcus region was exposed. (Right) Water’s view shows opacity of the left maxillary sinus, confirming the diagnosis
of maxillary sinusitis.

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relapse 3 months postoperatively. The patient
from the osteotomy group developed a class III
edge-to-edge malocclusion, and compensation
for the occlusion was achievable with orthodon-
tics. The other patient, who had distraction sur-
gery, also developed a class III malocclusion at
the first month of consolidation. Elastics were
used, but there was no change in occlusion. The
patient had to undergo a conventional Le Fort
I osteotomy at the distractor removal stage to
restore a class I occlusion. However, relapse into
class III malocclusion redeveloped 2 months
later. Orthodontic treatment was attempted to
correct the malocclusion, but the occlusion re-
mained as class III. It was noted that this patient
had a very severe palatal scar from a previous
palatal cleft repair. This seems to be the main
factor that contributed to the repeated relapse,
and both distraction with internal distractors
and conventional osteotomy were performed
but failed to correct the malocclusion. The com-
plications encountered in both techniques are
limited by a small sample size. A larger sample
size would be needed to confirm the true extent
of the morbidities.
In the study conducted by Heliovaara et al.,18
the skeletal stability of 40 consecutive patients
with unilateral cleft lip and palate following Le
Fort I osteotomy was evaluated. The mean max-
illary advancement was 3.9 mm (range, 0 to 8.9
mm), and the mean vertical lengthening was 4.5
mm (range, – 0.6 to 10.5 mm). The mean hor-
izontal and vertical relapses during the first post-
operative year were 20.5 percent and 22.2 per-
cent, respectively. The authors believed that
there was a significant correlation between
amount of maxillary advancement and relapse
in both the horizontal and vertical planes. In
this study, the A point relapsed vertically 6 per-
cent and 33 percent in the conventional osteot-
omy group during the second to eighth weeks
and the eighth to twelfth weeks postoperatively,
respectively. The degree of relapse obtained in
this study was similar to that recorded by Hous-
ton et al.,19 who also evaluated the surgical and
postsurgical cephalometric changes in maxillary
position after transpalatal osteotomy at the Le
Fort I level in 30 cleft lip and palate patients.
The mean horizontal and vertical changes in
their study were 9 mm and 3 mm, respectively
(relapses of 7 percent horizontally and 23 per-
cent vertically). Posnick and Dagyd20 and
Hirano and Suzuki21 found that after maxillary
advancement by conventional orthognathic sur-
gery, relapse of the maxilla ranged from 20 to 30
percent at follow-up, despite the insertion of
bone grafts and fixation of miniplates. Due to
the relapse problems encountered, Posnick and
Taylor22 advocated overcorrection of the maxilla
to overcome the skeletal relapse.
Distraction involves gradual advancement of
the Le Fort I maxillary segment. Compared with
conventional Le Fort I osteotomy, it allows
greater protraction distances. This technique
allows the soft-tissue musculature that limits the
advancement obtained intraoperatively to ac-
commodate gradually. In contrast to other stud-
ies of patients with cleft lip and palate, this study,
for the first time using evidence-based data, has
shown that there was actual further advance-
ment of 25 percent and 15 percent at the A point
and P point, respectively, in the horizontal plane
during the eighth to twelfth week postopera-
tively. As with vertical movement of A point,
further downward movement of 15 percent dur-
ing the second to eighth weeks and 10 percent
during the eighth to twelfth weeks was noted.
This downward movement of the maxilla could
be attributed to the use of elastic traction to
control the occlusion during the consolidation
period of distraction, when the regenerated cal-
lus remains malleable. Although similar elastic
traction was also applied to the conventional
osteotomy group in an attempt to stabilize the
occlusion, relapse of the osteotomy further
backward was noted and was particularly signif-
icant in the first 3 postoperative months.
CONCLUSIONS
Advancement of the cleft maxilla to a mod-
erate extent can be achieved with either con-
ventional osteotomy or distraction osteogenesis.
This study demonstrates that similar intraoper-
ative and postoperative complications may de-
velop in cleft lip and palate patients treated with
distraction by internal maxillary distractors or
by conventional osteotomy. With either tech-
nique, clinical occlusal relapse can develop in
the transposed maxilla during the early postop-
erative period. Skeletal relapse tends to occur in
the osteotomy group, whereas the distracted
maxilla advanced further during the early post-
operative period. These preliminary results
show that distraction of the cleft maxilla pro-
vided better skeletal stability for maintaining its
advanced position than conventional cleft or-
thognathic surgery. However, a longer follow-up
1007
 Plastic and Reconstructive Surgery • September 15, 2006
is needed to evaluate the true extent of the
stability of cleft maxillary osteotomy by distrac-
tion osteogenesis.
Prof. Lim K. Cheung
Oral and Maxillofacial Surgery
2/F Prince Philip Dental Hospital
34 Hospital Road
Hong Kong SAR, China
lkcheung@hku.hk
ACKNOWLEDGMENT
This clinical study was supported by the Competitive
Earnmarked Research Grant from the Hong Kong Re-
search Grant Council (reference code HKU 7577/05M).
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