J Oral Maxillofac Surg

59:1492-1496, 2001

Maxillary Distraction Osteogenesis for

Cleft Lip and Palate Children Using an
External, Adjustable, Rigid Distraction
Device: A Report of 2 Cases
Kiyoshi Harada, DDS, PhD,* Yoshiyuki Baba, DDS, PhD,†
Kimie Ohyama, DDS, PhD,‡ and Shoji Enomoto, DDS, PhD§

Distraction osteogenesis is a useful method for in vivo
bone regeneration. In this method, osteotomized
bone segments are distracted gradually at a regular
interval of 1 mm/d after surgery, and callus is
stretched with a distraction device to generate new
bone formation. The concept of this technique was
first described by Codivilla in 1905,1 and its biologic
principle for regenerating hard and soft tissue was
further developed as “a law of tension-stress effect”
by Ilizarov.2,3 Recently, various devices and tech-
niques for distraction osteogenesis have been re-
ported in the field of oral and maxillofacial surgery.4-8
An external, adjustable, rigid distraction device
(Rigid External Distraction [RED] System; KLS-Martin
L.P., Tuttlingen, Germany) is now being used for
maxillary distraction osteogenesis. This system was
first designed and reported by Polley and Figueroa.9,10
At our hospital, 2 cleft lip and palate children with
severe maxillary hypoplasia underwent maxillary dis-
traction osteogenesis using this system. Postoperative
changes in the maxilla were examined up to 1 year
after surgery with computed tomography (CT), three-
dimensional CT (3D-CT), and lateral cephalograms.
This report describes the results of these examina-
tions and discusses the advantages and disadvantages
of the distraction system.
Report of Cases
Patient 1 was a 9-year-old boy with a right cleft lip and
palate and patient 2 was an 11-year-old girl with a left cleft
lip and alveolus. In both cases, there was significant maxil-
lary hypoplasia and a preoperative overjet of ⫺10 mm.
Neither preoperative orthodontic therapy nor preoperative
secondary bone grafting into the alveolar cleft had been
performed.
The patients underwent a high Le Fort I osteotomy.
General anesthesia was performed using orotracheal intu-
bation because the halo had to be fixed to the head before
emergence. The maxilla was completely mobilized, and
titanium miniscrews were inserted above and below the
osteotomy in the lateral vertical maxillary buttress and near
the anterior nasal spine as bone markers. After wound
closure, the halo was fixed with 2 titanium scalp screws per
side (Fig 1).

Received from the Graduate School, Tokyo Medical and Dental

University, Tokyo, Japan.
*Assistant Professor, Branch of Oral Surgery, Department of Oral
Restitution, Division of Oral Health Sciences.
†Assistant Professor, Branch of Maxillofacial Orthognathics, De-
partment of Maxillofacial Reconstruction and Function, Division of
Maxillofacial/Neck Reconstruction.
‡Associate Professor, Branch of Maxillofacial Orthognathics, De-
partment of Maxillofacial Reconstruction and Function, Division of
Maxillofacial/Neck Reconstruction.
§Professor, Branch of Oral Surgery, Department of Oral Restitu-
tion, Division of Oral Health Sciences.
Address correspondence and reprint requests to Dr Harada:
Branch of Oral Surgery, Department of Oral Restitution, Division of
Oral Health Sciences, Graduate School, Tokyo Medical and Dental
University 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan;
e-mail: harada.osur@tmd.ac.jp
© 2001 American Association of Oral and Maxillofacial Surgeons
0278-2391/01/5912-0020$35.00/0 FIGURE 1. The device applied to a cleft patient undergoing maxillary
doi:10.1053/joms.2001.28292 distraction (patient 1).

1492
HARADA ET AL
FIGURE 2. Preoperative (A) and 1-year postoperative (B) lateral facial photographs of a cleft patient (patient 1). The preoperative deficiencies in
the midface are improved.
Maxillary distraction was begun on the second (patient 1)
and fourth (patient 2) postoperative days, respectively. It
was performed at a rate of 0.5 mm every morning and
evening, for a total of 1 mm/d. The duration of maxillary
distraction was 31 days in case 1 and 18 days in case 2. After
completion of the distraction, the device was left in place
during consolidation. The consolidation periods for patients
1 and 2 were 24 days and 19 days, respectively. At the end
of the consolidation period, a topical anesthetic was ap-
plied, and the scalp screws and halo were removed. After
removal of the device, a removable orthodontic face mask
and elastic traction were used as a retainer.
CT, 3D-CT, and lateral cephalograms were obtained pre-
operatively, immediately after removal of the device (about
2 months after surgery), and at 6 months and 1 year after
surgery. The amount of new bone formation in the dis-
tracted zone was examined on the CT and 3D-CT scans. On
the lateral cephalograms, changes in the position of anterior
nasal spine (ANS) and U1 were measured on the coordinate
axes passing through nasion (N). The movements of the
examined points were represented as linear measurements
in millimeters on the X and Y axes. Anterior and superior
movements of the examined points were indicated by a
positive value, and the posterior and inferior changes were
indicated by a negative value.
No complications occurred during the follow-up period
in either case. The wounds left by the scalp screws healed
7 to 10 days after removal of the device.
FIGURE 3. Preoperative (A) and 1-year postoperative (B) intraoral photographs (lateral view) of a cleft patient (patient 2). The preoperative anterior
crossbite is corrected.
1493
Preoperative and postoperative lateral facial views of pa-
tient 1 are shown in Figure 2. The preoperative skeletal and
soft tissue deficiencies in the midface were improved. Pre-
operative and postoperative intraoral views of patient 2 are
shown in Figure 3. The preoperative anterior crossbite was
also corrected.
Immediately after removal of the device (about 2 months
after surgery), a faint bone-like radiopacity was observed in
the distracted pterygomaxillary junction on the CT scan
(horizontal section). The distracted zone was filled with a
bone-like radiopacity by 6 months after surgery, and no
remarkable difference was observed between the radiopac-
ities at 6 months and 1 year after the operation (Fig 4). The
step caused by distraction in the anterior wall of the max-
illary sinus was noted on the 3D-CT scan immediately after
removal of the device. However, the step progressively
smoothed during the year after the operation (Fig 5).
There was a marked increase of the X-axis value for ANS
because of maxillary advancement in both cases (Fig 6).
However, this value progressively decreased from the time
of removal of the device up to 6 months postoperatively in
both cases, dropping to 83% and 85%, respectively, of the
original increase obtained by the distraction (Fig 6). From 6
months to 1 year after surgery, the X-axis value of the ANS
was stable. A decrease in the Y-axis value for the position of
ANS because of maxillary distraction was also observed in
both patient, and this value remained fairly stable after
removal of the device (Fig 6). There was also a marked
1494
increase of the X-axis value and a decrease of the Y-axis
value for U1 after maxillary distraction in both patients (Fig
7). These values remained stable after removal of the de-
vice. However, in patient 1, the change in U1 caused by
maxillary distraction tended to be slightly larger than that in
the ANS.
Discussion
There are few reports describing the postoperative
changes of the maxilla after maxillary distraction us-
ing the RED device.9-11 In the postoperative CT and
3D-CT images of the 2 patients in this report, the
distracted pterygomaxillary junction was filled with
a newly formed bone-like radiopacity by 6 months
after surgery, and the step caused by maxillary dis-
traction in the anterior wall of the maxillary sinus
progressively smoothed during the year after the op-
MAXILLARY DISTRACTION FOR CLP CHILDREN
FIGURE 4. Preoperative (A), approximately
2 months postoperative (immediately after
removal of the device) (B), 6 months postop-
erative (C), and 1 year postoperative (D) CT
images (horizontal sections) of a cleft patient
(patient 1). Immediately after removal of the
device (about 2 months after surgery), a faint
bone-like radiopacity is observed in the dis-
tracted pterygomaxillary junction (arrow-
heads in B). This distracted zone is filled with
a bone-like radiopacity by 6 months after
surgery (arrowheads in C and D).
eration. However, ossification was observed as early
as 2 months after surgery. In the lateral cephalometric
analysis, the ANS was stable superoinferiorly after
removal of the device. However, a posterior change
in ANS was observed from the time of removal of the
device up to 6 months postoperatively.
Although the device and technique were different,
Molina et al5 observed no relapse after maxillary dis-
traction in cleft lip-palate and prognathic patients
during the mixed dentition stage. Cedars et al12 ob-
served excellent stability of the advancement at the
occlusal level and some relapse at the level of orbitale
after midface advancement using their distraction
technique. In this report, the period of the posterior
change in the ANS corresponded to the period of new
bone formation in the pterygomaxillary junction after
distraction. Although one cannot conclude that this
HARADA ET AL 1495

FIGURE 5. Preoperative (A), approximately 2 months postoperative (immediately after removal of the device) (B), 6 months postoperative (C), and
1 year postoperative (D) 3D-CT images of a cleft patient (patient 2). Immediately after removal of the device (about 2 months after surgery), the step
caused by distraction in the anterior wall of the maxillary sinus is apparent (arrow in B). This step progressively smoothes until 1 year after surgery
(arrows in C and D).

posterior change was skeletal relapse, it is known that
skeletal change after removal of the device can occur
until sufficient new bone has been formed in the
distracted bone gap (ie, 6 months postoperatively). In
both patients in this report, a posterior vertical open
bite was observed immediately after maxillary distrac-
tion, and this open bite resolved by 6 months after
distraction. The resolution of the posterior vertical
open bite may be caused by counterclockwise rota-
tion of the maxilla, and the counterclockwise rotation
of the maxilla may cause the posterior change of ANS.
Another possibility is that when maxillary advance-

FIGURE 6. Preoperative to 1 year postoperative change in the

anterior nasal spine (ANS). Upper, Change in X-axis value. Lower,
Change in Y-axis value. Preop, preoperative; 2M, approximately 2
months postoperative (immediately after removal of the device); 6M, 6
months postoperative; 1Y, 1 year postoperative; case I, patient 1;
case II, patient 2.
FIGURE 7. Preoperative to 1 year postoperative change of Upper-1
(U1). Upper, Change in X-axis value. Lower, Change in Y-axis value.
Preop, preoperative; 2M, approximately 2 months postoperative (im-
mediately after removal of the device); 6M, 6-months postoperative;
1Y, 1 year postoperative; case I, patient 1; case II, patient 2.
1496
ment is performed, ANS may undergo resorption un-
der the pressure of the lip and base of the nose,
especially in patients with scarring as a result of cleft
lip surgery. This ANS resorption may cause a seeming
posterior change of ANS. If the posterior change of
ANS was caused by skeletal relapse, the stability of the
maxillary position after distraction might have been
affected by the scarring caused by the cleft lip and
palate surgery.
In this report, the dental (U1) change after the
removal of the device was stable. No remarkable
counterclockwise rotation of the palatal plane was
observed during distraction (data not shown). How-
ever, in patient 1, the anterior change in U1 caused by
the distraction tended to be larger (approximately 3
mm) than that in the ANS. This suggests that the
traction force may cause dental changes during the
distraction period, because the technique delivers
the force through the maxillary teeth. In patient 1, the
upper first molars had not erupted at the time of
maxillary distraction, and the upper second decidu-
ous molars were used for anchorage. Because the root
support of the deciduous molar in the transitional
dentition stage is less than that of the permanent
molar, we believe that the traction force likely caused
the dental change in patient 1. In addition, when
using this system, insufficient dental support may lead
to inadequate retention and decreased stability in the
maxillary position after distraction. Therefore, suffi-
cient dental support in the maxilla is a necessary
condition in maxillary distraction osteogenesis using
this system. It is important to check the stage of
dental development and the availability of teeth with
sufficient root anchorage at the time of distraction
when using this system.
The RED system has the following advantages: 1)
maxillary distraction can be performed regardless of
whether or not secondary bone grafting in the alveo-
lar cleft has been done; 2) compared with the con-
ventional Le Fort I osteotomy, the operative morbidity
is decreased and the operation takes less time; 3) no
foreign bodies (eg, metallic plates, screws, or wires)
are left in the wound; 4) it is easy to change the
distraction vectors, and different distraction rates can
be applied on the right and left side segments of the
maxilla; and 5) large advancements of the maxilla can
be obtained, and the concave facial profile secondary
to maxillary hypoplasia can be improved.
On the other hand, this system has the following
disadvantages: 1) the external device is conspicuous
so some patients dislike going to school or out in
public until it has been removed; and 2) the traction
force delivered through the teeth can cause dental
change, especially in patients with poor root support
or multiple missing teeth. Generally, when perform-
ing maxillary advancement surgery for growing chil-
MAXILLARY DISTRACTION FOR CLP CHILDREN
dren, it is difficult to decide on the advancement
distance of the maxilla because growth prediction in
childhood is very difficult. When growing patients
undergo maxillary distraction, an additional proce-
dure may be required at the completion of growth.
Up to now, maxillary hypoplasia in cleft lip and
palate patients has been treated with anterior elastic
traction and lateral expansion of the maxilla during
the growing stage, and/or orthognathic surgery (max-
illary advancement by Le Fort I osteotomy) after the
growing stage. However, large, stable advancements
of the maxilla are not obtained with these treatments.
The technique of maxillary distraction osteogenesis
using the RED system may be an alternative to solve
this problem. Although treatment with this system is
useful and effective for maxillary hypoplasia in cleft
lip and palate patients, further investigation on more
patients and longer term follow-up are needed to ex-
amine for relapse, velopharyngeal function, speech,
and maxillofacial growth after maxillary distraction.
Acknowledgment
We indebted to Dr John W. Polley and Dr Alvaro A. Figueroa for
instructing us in the technique of the RED System and to Professor
Takayuki Kuroda for his helpful discussion.
References
1. Codivilla A: On the means of lengthening in the lower limbs,
muscles and tissues which are shortened through deformity.
Am J Orthop Surg 2:353, 1905
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of tissues: Part 1. The influence of stability of fixation and
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4. Niederhagen B, Braumann B, Berge S, et al: Tooth-borne dis-
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5. Molina F, Ortiz Monasterio F, de la Paz Aguilar M, et al: Maxil-
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