Nghiên cứu ghép xương cho khe hở cung hàm trên bệnh nhân khe hở môi và vòm miệng (TT ANH)

1
INTRODUCTION
Cleft lip and palate are common birth defects in Vietnam and the
world. Globally, the proportion of newborns suffering from this type of
disability ranges from 1/750 - 1/1000, particularly on the geographical
area and socio-economic conditions in that region. In Vietnam, this ratio
is about 1/1000 - 2/1000.
Children with cleft lip and palate suffer from abnormal changes,
locally or generally, anotomy or functions, psychologicalyl or
physiologically. Among them, the anatomical changes directly affect the
tooth formation and eruption in the cleft area, leading to missing or
displaced teeth, crowded teeth. As a result, the patient will experience
changes in the occlusion, chewing function, and as a result, the child will
get choke while eating or drinking, suffer from respiratory diseases,
hearing and pronunciation disorders, These things greatly affect the
psychology of children, they become guilty, inferiority and alienation
from the community.
Treatment of cleft lip and palate patients requires the coordination of
specialized doctors, including: plastic surgeon, anesthesiologist,
orthodontist, pediatrician , ENT specialists, linguistics and psychologist,
with a combination of therapies and techniques for a long time. In which,
plastic surgery for closing the gap is the first and most basic treatment
Along with surgery for the cleft lip and palate, the bone grafting for the
alveolar cleft is also a necessary treatment. Alveolar bone graft helps to
close the cleft of the jawbone, restores anatomical morphology of the dental
arch, makes the anterior border of maxillary uninterrupted, closes the fistula
(if exsist). Thereby stimulating tooth eruption in the cleft area, creating a full
bone volume for orthodontic treatment and restoring the missing teeth on the
cleft, making the nostrils in the cleft side more aesthetic.
For alveolar cleft graft, most surgeons have used autologous grafts
harvested from the skull, the tibia, the mandible, the iliac crest. In

addition, with the development of biotmaterial, clinicians also usedt
autologous bone graft in combination with growth factors and achieved
promising results. In Vietnam, a number of studies on autologous bone
grafting into the alveolar cleft have been published, however, no studies
have evaluated the effectiveness of combining autologous bone with
growth factors. Therefore, we conduct this research with 2 goals:
1.
To describe the alveolar cleft with clinical and radiographic
features in patients with cleft lip and palate .
2.
To evaluate the bone resorption when using iliac bone, with
platelet-rich plasma and bone substitutes.


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LITERATURE REVIEW
1.1. ANATOMY OF THE LIP AN PALATE
1.1.1. Lip: The structures that surround the oral aperture. In the central
region their superior border corresponds to the inferior margin of the base
of the nose. Laterally, their limits follow the alar sulci and the upper and
lower lips join at the oral commissures. The inferior limit of the lips in
the central region is the mentolabial sulcus
1.1.2. Palate: The palate divides the nasal cavity and the oral cavity,
with the hard palate positioned anteriorly and the soft palate posteriorly.
The soft palate is distinguished from the hard palate at the front of the
mouth in that it does not contain bone
1.1.3. Maxillary alveolar bone anatomy:
The maxillary alveolar bone is part of the lower edge of the
maxillary bone and forms the upper dental arch. Its front limit is the
upper lip. The oral mucosa covers its outer and inner surface , in the

middle there is dental arch. Alveolar bone connects to the ligament
around the tooth, and root.
The dental arch is a part of the maxillary that has a curved shape
without interruption. The dental arch is covered by a attached and mobile
gingival epithelium, which supports the temporary and permanent teeth.
There are also permanent tooth germs in the bone structure. When the
cleft palate appears, there is disruption of the bone structure and covering
gingival epithelium. The change in anatomical morphology leads to a
change in the arrangement of teeth in the dental arch or an abnormal
position, or number of permanent tooth germs in the cleft area.
1.2. CLASSIFICATION OF CLEFT LIP AND PALATE.
Pfeiffer (Germany) has created diagram about the classification of
cleft lips and palate. In 1971, Kernahan introduced a Y-diagram to
describe his classification
In 1976, Millard modified the Kamahan diagram and considered it
as a new classification, named “Striped Y”.
1.3. CÁC ANATOMIC ABNORMALIES IN CLEFT LIP AND
PALATE PATIENTS
Anatomic abnormalies in lip and nose
Anatomic abnormalies in palate
Changes in muscle system
The pre-maxillary at both sides aren‟t connected to the poseterior
area of the maxillary.
Anatomic abnormalies exsisted in the dental arch
The cartilage on the affected side still does not achieve the
necessary proportion.


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Erupting disorders still exist, along with malocclusion.

1.4. HEALING MECHANISM OF THE GRAFT
Bone resorption and bone regeneration are two main and
simultaneous activities . Early resorption is primarily caused by immune
cells, which provide conditions for healing, and produce factors that
cause bone resorption. The bone regeneration is mainly stimulated by
undifferentiated osteocytic cells and mesenchymal cells from
neovascular vessels.
1.5. PLATELET-RICH PLASMA (PRP)
PRP is extracted from autogolous blood, with a high-concentration
of platelet. It contains many important growth factors, such as PDGF,
TGF-B1, TGF-B2, EGF which take important roles in healing and bone
regeneration.
1.6. GRAFTING MATERIAL
There are 4 types of grafting materials:
- Autologous bone.
- Allograft.
- Xenograft.
- Alloplastic grafts.
1.6.1. Autologous (or autogenous) bone: involves utilizing bone
obtained from the same individual receiving the graft. Bone can be
harvested from non-essential bones, such as from the iliac crest, or more
commonly in oral and maxillofacial surgery, from the mandibular
symphysis (chin area) or anterior mandibular ramus (the coronoid
process); this is particularly true for block grafts, in which a small block
of bone is placed whole in the area being grafted. When a block graft
will be performed, autogenous bone is the most preferred because there
is less risk of the graft rejection because the graft originated from the
patient's own body.[4] As indicated in the chart above, such a graft
would be osteoinductive and osteogenic, as well as osteoconductive. A
negative aspect of autologous grafts is that an additional surgical site is

required, in effect adding another potential location for post-operative
pain and complications.
1.6.2. Allograft: Allograft bone, like autogenous bone, is derived from
humans; the difference is that allograft is harvested from an individual
other than the one receiving the graft. Allograft bone can be taken
from cadavers that have donated their bone so that it can be used for
living people who are in need of it; it is typically sourced from a bone
bank. Bone banks also supply allograft bone sourced from living human
bone donors (usually hospital inpatients) who are undergoing elective


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total hip arthroplasty (total hip replacement surgery). During total hip
replacement, the orthopaedic surgeon removes the patient's femoral
head, as a necessary part of the process of inserting the artificial hip
prosthesis. The femoral head is a roughly spherical area of bone, located
at the proximal end of the femur, with a diameter of 45 mm to 56 mm in
adult humans. The patient's femoral head is most frequently discarded
to hospital waste at the end of the surgical procedure. However, if a
patient satisfies a number of stringent regulatory, medical and social
history criteria, and provides informed consent, their femoral head may
be deposited in the hospital's bone bank.
1.6.3. Alloplastic grafts: An alloplastic graft is composed of material
that is not taken from an animal or human source. Alloplastic grafts can
be derived from natural sources (such as an elements or minerals),
synthetic (man-made) substances, or a combination of the two. One
reason many dentists prefer alloplastic grafts is that they do not require
tissue to be harvested from another source. Alloplastic grafts can be
made of hydroxyapatite (HA), calcium carbonate, and tricalcium
phosphate. Hydroxyapatite is the most frequently used due to its

strength, durability, and ability to integrate well with bone. In fact, a
large percentage of human bone is composed of a form of
hydroxyapatite. Calcium carbonate is becoming less popular because it
tends to resorb more quickly and make the bone susceptible to breakage
1.6.4. Xenograft: Tissue or organs from an individual of one species
transplanted into or grafted onto an organism of another species, genus,
or family. They binds well to the bone in the receiving area, but its slow
resorptions rate can have negative effects on the newly formed bone,
thus affecting clinical outcomes.
Due to the prevalence of other types of bone grafting, less common
bone species is used, and because of the risk of causing immune
reactions, this material is quite limited.
1.7. BONE RESORPTION AFTER ALVEOLAR GRAFTING
World literature describes the failure rate of iliac bone graft in
patients with cleft palate and some data related to bone resorption
process after grafting. Kinderland was the first author to come up with
the idea of assessing bone resorption level, he created a scale of 4 levels
as follows:
- Grade I: Bone resorption from 0 -25%
- Grade II: Bone resorption from 25 - 50%
- Grade III: Bone resorption from 50 - 75%
- Grade IV: Bone resorption from 75 - 100%


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Bone resorption at levels I and II is considered a successful bone
graft surgery. Bone resorption at levels III and IV is considered a failed
surgery. Success rates for bone grafting in medicine are also diverse. In
cases of bone grafting before canine eruption, the success rate is about
72% to 90%, while in bone grafting after canines eruption, the rate is

about 67% to 85%. Kinderland and his colleagues performed bone
grafting for 38 patients at the time the canine teeth had erupted and the
success rate was 73%. The success rate in the Newland study was
nearly 90% with 72 patients. Filho also achieved a 72% success rate in
his study of 50 patients who had surgery before the canine teeth had
erupted.
Factors such as: the time of surgery before or after the canine erupt,
the degree of tooth formation or the orthodontic treatment after bone
grafting ... should be carefully considered so that the bone graft results
are as expected.
1.8. TIME FOR ALVEOLAR GRAFTING
The optimal age for alveolar bone grafting after cleft lip and palate
repair is still controversial.The development of the vertical and
horizontal upper jaw bone is nearly completed by the age of 8, and then
the maxilla develops vertically by the addition of the alveolar bone.
Along with the reason that the age of the lateral incisors eruption is
usually at the age of 7 to 8 years old, by the time the children aged 9 to
11 years old canine erupt 1/4 to ½. At the age of 11 to 12, dentists and
plastic surgeons advocate for alveolar bone grafting later in the mixed
tooth period when children are 7 to 12 years old. However, alveolar
bone graft surgery is still conducted later than 12 years old with the
purpose of supporting orthodontic and prosthetic prosthesis.
1.9. HISTORY OF ALVEOLAR GRAFTING
Since 1908 Lexer has tried grafting alveolar bone in the alveolar
cleft, at the same time with cleft lip repair. But it was not until 1914 that
Drachter published the first report on the success of the alveolar bone
graft using the tibia bone in cleft and palate patients. By 1931, Veau
also performed the first alveolar cleft graft with lip repair in one phase.
But also from 1959, Ritter was the first to issue a warning about the
underdevelopment of the maxilla caused by alveolar bone graft.

Pruzansky (1964) frankly criticized the first alveolar bone grafting in
cleft lip and palate patients, based on his research that he suggested that
alveolar bone grafting should be done after cleft lip and palate repair,
and until mixed teeth.
Bjork and Skieller (1974) show that the vertical and horizontal
development of the maxilla is nearly accomplished by the age of 8,


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and most of the subsequent development of the maxilla follows
vertically by the growing of the alveolar bone. teeth, plastic surgeons
advocating for alveolar bone grafting are as follows: after the child has
been cleft lip and palate repaired, at the time of the child over 7 years
old, when they have mixed teeth.
Since then, there have been many reports in the world about the
success and effectiveness of alveolar bone grafting in cleft lip and
palate patients. Boyne and Sands (1976) in their report stated that
alveolar bone grafting should be performed at the early stage of mixed
teeth, when the child is aged 7-11 years old, after lip and arch shaping.
A report by Abyholm et al. (1982) showed that the alveolar bone graft
after lip and palate surgery in the early stage of mixed teeth of children,
when children aged 7-11 years, that is the age lateral incisors and
canines erupt, will stimulate the formation of root teeth and the growth
of these teeth.
In Vietnam from 2009 to 2012, three studies have been published
on this issue: Nguyen Manh Ha (2009) "Evaluating the effectiveness of
alveolar bone graft surgery using iliac bone in patients after cleft lip and
palate repain." Nguyen Huu Nam (2011), "Research using porous bone
graft from the tibia to treat alveolar bone defects in patients with
congenital cleft palate"; Vo Van Nhan (2012), "Studying implant

transplantation in patients who received jaw bone implants after surgery
to create full cleft lip and palate".
Along with the development of science and biotechnology,
researchers have successfully applied clinically when using growth
factors and biological materials in general bone graft and cleft palate
graft. in particular to increase bone mass gained after healing. It should
be noted in the studies of: Maria Nagata et al (2008), Giuseppe Intini
(2009), Altaf H (2013) and many other studies.
MATERIALS AND METHODS
2.1. SUBJECTS
The subjects of the study were all patients who had cleft lip and
palate repair, referred at the Odonto-Stomatology Hospital - Central
Hospital and Hanoi Medical University Hospital. , wishing to have
alveolar bone graft surgery.
Inclusion criteria:
 The patient, regardless of gender, 8 years of age or older. He or
she has had cleft lip and palate repair.


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 Patients who received orthodontic treatment 6 months prior to
surgery.
 Patients and their families agreed to participate in this study.
Exclusion criteria:
 We exclude patients who have had cleft lip and palate repair but
do not have alveolar cleft.
 Patients who are not receiving orthodontic treatment prior to the
surgery.
 Patients with compromised medical condition
 Patients whose medical records are not completed.

 Patients who do not agree to participate in the study.
2.2. METHODOLOGY
2.2.1. Study design
This study was designed as a controlled clinical trial. Study objectives:
To describe the clinical features of alveolar cleft and their relationship with
other aspects. To compare the outcome of bone grafting between 2 groups:
Group 1 using iliac bone graft with combination of bone substitutes and
platelet-rich plasma. Group 2 using iliac bone alone.
2.2.2. Sample size
The study included 2 groups, 20 patients were recruited in each
group, with the total of 40 patients.
The patients were recruited from September, 2013 to September,
2017.
2.2.3. Data collecting
According to the designed record, including: Patient interviews,
clinical and subclinical examination indicators (X-ray, CBCT).
CT-Conbeam film is used to evaluate the bony structure on both
sides of the cleft, including the width and height of the cleft palate, before
and after the bone graft surgery. As well as monitoring the eruption of
teeth which have not yet erupted into the bone graft area after surgery.
To measure the height of the cleft :
h1 + h2
To measure
width of the cleft :
H =the
--------------------2
w1 + w2
W = --------------------2

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2.2.4. Patient follow-up
The patient was clinically monitored postoperatively until discharge
(7 to l0 days). Clinical examination, X-ray for evaluation after 7 days, 3
months, 6 months and after one year post-operatively.
2.2.5. Evaluating scale
 Good: the grafting is good, no pus leakage, bone is not discharged,
patients with nasal fistula have been closed, the volume of bone graft is
still sufficient and restores the morphology of the maxillary, X-ray
showed that the bone graft was not discharged, the bone was good around
the gap.
 Bad: The grafting has pus leak, graft bone is eliminated, patients
still have nasopharyngeal fistula (eating, drinking food, water through
the nose), X-ray shows bone graft is partially or completely resorbed)
 The closure of the nasal fistula: the patient no longer has food or
drink through the nose while drinking or eating. Physical examination
showed that the fistula was closed.
 Canine eruption into the grafting area. By clinical examination and
X-ray. Calculated by the distance from the edge of incisor to the alveolar bone
 Bone resorption: It is assessed by measuring the height of the
alveolar bone in the grafted area, at a certain position, by CT - Cone beam.
At the time after 3 months of surgery
o Height measurement position: determined at the line between the
maxillary cleft (where the bone has been grafted), from the side of
adjacent teeth, with the height measured from the arch of the maxillary
bone by the base of the nose to the ridge of the jaw.
o Bone resorption level was calculated by comparing height (H)
measured before surgery (height to be compensated), and height
measured at 3 months after surgery.
o Comparison of bone resorption level between simple iliac crest

bone grafting method with iliac crest + PRP + bone substitutes.
2.2.6. Statistically analyses
 After collecting the data. We analyzed data using SPSS 16.0 :
 Statistical test is used to determine the difference between age
groups, gender, whether or not the nasal fistula is present, the parameters
measured before and after surgery ...
 Study variables are presented in the percentage and average value.
 Research results are presented in the form of a single table, double
tables and appropriate charts.
 Errors and errors prevention: Use medical record form. The
information is consistent and clear.


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2.2.7. Time and location of the trial
 The trial is studied in the Department of Maxillofacial Surgery, Hanoi
National Hospital of Odonto-Stomatology, from Sep, 2013 to Sep, 2017.
2.2.8. Ethical approval.
 The research proposal was approved by the Council for
Graduating study of the Faculty of Odonto-Stomatology - Hanoi Medical
University to ensure scientific research.
 The research protocol was approved by the Scientific Council of
Hanoi Central Odonto-Stomatology Hospital to conduct research at the
Hospital.
2.3. SURGERY PROTOCOL
2.3.1. Indications and contra-indications
Indications:
 All patients aged more than 8 years old, healthy enough for
general anesthesia, no systemic disease which may lead to complications
during surgery.

 Had cleft lip and palate repair. There is a gap or missing bone in
the alveolus.
 No infection or pathologic conditions in oral cavity.
 No pathologic conditions or anatomic abnomalies in the donor site.
Contra-indications:
 Compromised medical status that will not allow for general
anesthesia.
 Infection or pathologic condition at the alveolar cleft.
 Anatomic anomalies or pathologic condition at the donnor site.
2.3.2. Pre-operation preparation
 Oral hygience, tooth treatment.
 General examination the day before surgery.
2.3.3. Anesthesia : General anesthesia
2.3.4. Alveolar cleft grafting procedure :
 Step 1 : Local anesthesia.
 Step 2 : Mucosal incision, open the flap.
 Step 3 : Elevator the full flap.
 Step 4 : Suture the base flap to contain the graft.
 Step 5 : Grafting.
 Step 6 : Flap retention.
 Step 7 : Suturing


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2.3.5. Bone harvesting from iliac bone procedures :
 Make the incision in the center and through the full thickness of
the skin, , on the iliac crest.
 Dissect the muscle to expose the periosteum of the iliac crest.
 Make the meningeal incision, three-sided periosteal dissection:
internal, anterior, posterior aspect of the iliac crest.

 Cut the bone, across the iliac crest in three directions: inside,
before, after. Next, harvest the iliac crest from the inside.
 Use bone drill or small chisel to make pourous hole in the iliac
graft. Harvest the graft with both cortical and purous bone.
 Keep the graft in the cup with warm sterile saline.
 Suturing the muscle and put a drainage at the iliac site, suturing the
donor site.
2.3.6. Platelet-rich plasma extraction :
 Obtain WB by venipuncture in acid citrate dextrose (ACD) tubes
 Do not chill the blood at any time before or during platelet
separation.
 Centrifuge the blood using a „soft‟ spin.
 Transfer the supernatant plasma containing platelets into another
sterile tube (without anticoagulant).
 Centrifuge tube at a higher speed (a hard spin) to obtain a platelet
concentrate.
 The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma
(PPP). At the bottom of the tube, platelet pellets are formed.
 Remove PPP and suspend the platelet pellets in a minimum
quantity of plasma (2-4 mL) by gently shaking the tube.
2.3.7.
Preparation of combined graft with bone substitutes,
iliac bone and PRP.
 Make a bone graft, which is a bone mass, including the cortical and
porous bone. Bone mass is equal to the height of the cleft. The horizontal
width should be sufficient to compensate for the lack of bone in the gap.
 Mix platelet-rich plasma, with porous bone and bone substitutes.
 Carry out bone grafting techniques such as standard technical
procedures.
2.3.8. Post-operative care: Local and general care.

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RESULTS
3.1. PRE-OPERATIVE FEATURES
Table 3.1: Age
Group
Group 1
Group 2
Age group
n
%
n
%
12
40,0
10 33,3
8-12 y
18
60
20 66.7
Above 12 y
Total
30
100
30 100
(p>0,05, Chi-square test)

p
0,592

0,359

20

18
20

Total
n
%
22 36,7
38 63.3
60 100

12
10

10

8-12t

>12t
0

>12t

8-12t
Group 1

Group 2

Chart 3.1: Age distribution
Table 3.2: Gender
Group
Group 1
Group 2
Gender
n
%
n
%
Male
10
33,3
16
53,3
Female
20
66,7
14
46,7
Total
30
100
30
100
(p>0,05, Chi-square test)

Total
n

%
26
43,3
34
56,7
60
100

20
20

16

14
Male

10

Female

10

Female
0

Male
Group 1

Group 2

Chart 3.2: Gender distribution

p
0,118


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Table 3.3: Types of cleft
Group 1
Group 2
Types
n
%
n
%
Unilateral
25
83,3
23 76,7
Bilateral
5
16,7
7
23,3
Total
30
100
30 100
Total of clefts
35

37
(p>0,05, Chi-square test)
Group

Total
n
%
48 80,0
12 20,0
60 100

p
0,519

Group 1

30

25 23

Group 2

20
5

10

7

0

Unilaterl

Bilateral

Chart 3.3: Distribution of cleft types
Table 3.4: Distribution of cleft side
Group
Group 1
Group 2
Total
p
Side
n
%
n
%
n
%
Right
18
51,4
14 37,8 32 44,4
0,246
Left
17
48,6
23 62,2 40 55,6
Total
35
100

37 100 72 100
(p>0,05, Chi-square test)
Table 3.5: Existence of oro-nasal fistula
Group 1
Group 2
Total
p
Group
n
%
n
%
n
%
Oronasal fistula
Existed
24
80 25 83,3 49 81,6 0,536
No exsited
6
20
5 16,7 11 18,4
Total
30 100 30 100 60 100
(p>0,05, Chi-square test)


13

25

Group 2

5
no existed
existed

24

Group 1
0

6

10

20

30

Chart 3.4: Oro-nasal fistula distribution
Table 3.6: Development and eruption of canine
Group
Group 1
Group 2
Total
Canine

n
2

16
17
35*

%
n
%
5,7
3
8,1
45,7 18 48,6
48,6 16 43,3
100 37* 100

n
5
34
33
72

%
5 0,336
32
60
100

Non - existed
Existed - Unerupted
Existed - Erupted
Total

(p>0,05, Chi-square test)
Table 3.7: Development and eruption of canine by age
Age
8-12
>12
Total
Canine
n
%
n
%
n
%
No existed
Unerupted
Group Erupted
1
Total
No existed
Unerupted
Group Erupted
2
Total
(p>0,05, Chi-square test)

1 2,85
12 34,28
0
0

1
4
17

1
11
0

2
7
16

2,70
29,72
0

p

p

2,85 2* 5,7
11,42 16* 45,7 0,238
48,6 17* 48,6
35 100
5,40 3* 8,1
18,91 18* 48,6 0,296
27,02 16* 43,2
37 100

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Table 3.8. Pre-operative measurement of cleft
Mean of cleft width
Mean of cleft height
(Mm)
(Mm)
Group 1 1(n=35)
8,70± 2,68
11,31±1,71
Group 2(n=37)
9,93±2,87
11,31±1,81
P
0,064
0,988
(p>0,05, Chi-square test)
3.2. POST-OPERATIVE RESULTS
Table 3.9: Results at 7th day
Group
Group 1
Group 2
Total
p
Results
n
%
n
%
n
%

Good
28
93,3
25 83,3 53 88,3 0,228
Bad
2
6,7
5
16,7
7
11,7
35
100
37 100 72 100
Total
(p>0,05, Chi-square test)
Group

6,7%

17%

100%

50%

bad
93,3%

83,3%

good

0%
group 1

group 2

Chart 3.5: Post-operative results at 7th day
Table 3.10: Result of the graft after 3 months
Group

Mean of height
(mm)
9,88±1,76

Group 1
(n=35)
Group 2
8,59±2,21
(n=37)
p
0,008
(p<0,05, Mann – Whitney test).

Resorption rate
(%)
12,54±9,45
23,68±16,54
0,0001*

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Table 3.11: Canine eruption after 3 months
Group 1
Group 2
Total
Group
n
%
n
%
n
%

p

Canine
Erupted
1
8,3
3 27,3 4 17,4 0,438
Unerupted
11 91,7 8 72,7 19 82.6
Total
12* 100 11* 100 23 100
(p>0,05, Chi-square test)
Table 3.12: Ora-nasal fistula after 3 months post-operation
Group 1
Group 2

Total
p
Group
n
%
n
%
n
%
Oro-nasal fistula
Closed
5
100
4
100
9
100 0,468
Unclosed
0
00
0
00
0
00
5* 100 4* 100
9
100
Total
(p>0,05, Chi-square test)
Table 3.13: Post-operative result at 6 months

Mean
Resorption rate
Resorption rate
Group
Height
(Compared with
(Compared with 3
baseline)
months)
Group 1
9,07±2,57
20,17±19,04
9,80±18,46
(n=35)
Group 2 2
7,72±3,33
30,68±31,49
13,18±2,701
(n=37)
0,011*
0,001*
0,041*
p
(p<0,05, Mann – Whitney test).
Table 3.14: Canine eruption after 6 months
Group 1
Group 2
Total
p
Group n

%
n
%
n
%
Canine
Erupted
6
50
6 54,54 12 52,17 0,536
Unerupted
6
50
5 45,46 11 47,83
Total
12* 100 11* 100 23 100
(p>0,05, Chi-square test)


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Group
Group 1
(n=35)
Group 2
(n=37)
p

Table 3.15: Post-operative results after 1 year
Mean Height

Resorption rate
Resorption rate
(Compared with
(Compared with 3
baseline)
months)
7,60±2,15
32,67±17,84
15,35±10,95
6,52±3,39

41,86±29,61

21,22±29,71

0,039
0,043
0,042
(p<0,05, Mann – Whitney test)
Table 3.16: Canine eruption after 1 year.
Group
Group 1
Group 2
Total
p
Canine
n %
n
%
n %

Erupted
10 83,33 8 72,72 18 78,26 0,198
Unerupted
2 16,66 3 27,27 5 21,74
Total
12* 100 11* 100 23 100
(p>0,05, Chi-square test)
Table 3.17: Change in bone height at observation time (n=35)
Bone height
Median Min Max
X ±SD
Baseline
3 months
6 months

11,31±1,71
9,88±1,76
9,07±2,57

11,2
10,1
9,6

7,7
5,6
1,9

14,2
13,3
12,9

1 year

7,60±2,15

8,2

1,7

9,9

p03=0,0001
p06=0,0001
p36=0,001
p012=0,0001
p312=0,0001
p612=0,0001

(p<0,05, paired t-test)

mm

15
10

5

9,07 ±2,57
7,6 ±2,15

0
Baseline
Ban
đầu

33 months
tháng

months
66 tháng

Time

Chart 3.6: Bone height change in group 1

1 1year
năm


17

Bone height
Baseline
3 months
6 months
1 year

Table 3.18: Bone height change in group 2
media
min

max
X ±sd
n
11,31±1,8
11,0
7,5
16,8
1
8,59±2,21
8,5
3,5
14,4
7,72±3,33
8,1
2,4
15,0
6,52±3,39

7,1

0

13,0

p03=0,0001
p06=0,0001
p36=0,012
p012=0,0001
p312=0,0001
p612=0,0001

(p<0,05, paired t-test)
Table 3.18: Bone height change in group 2 (n=37)
Bone height
X ±SD Median Min Max
Baseline
3 months
6 months

11,31±1,81
8,59±2,21
7,72±3,33

11,0
8,5
8,1

7,5
3,5
2,4

16,8
14,4
15,0

1 year

6,52±3,39

7,1

0

13,0

p03=0,0001
p06=0,0001
p36=0,012
p012=0,0001
p312=0,0001
p612=0,0001

(p<0,05, paired t-test)

mm

15
10
5

8,59±2,2

6,52±3,39

0
Ban
đầu
Baseline

7,72±3,33

66months
tháng

tháng
33month
Time

Chart 3.7: Bone height change in group 2

11year
năm


18

30

28

25

25
20

None

15

Secondary

10
5

5
2

0
Group 1

Group 2

Chart 3.8: Comparison between 2 group for secondary surgery.
DISCUSSION
4.1. ALVEOLAR CLEFT AND RELATED FACTOR
4.1.1. Age and gender
Most authors concluded that the best age for alveolar cleft grafting
is 8-12 years old. The reason given here is the timing of the eruption of
the lateral incisors and the canine, to create a complete bone base for
these teeth to grow. Berkowitz in 2006 also asserted that at this time the
development of the mid-face completely ended, the impact of bone
grafting did not change the middle layer of the face.
Based on the above studies, this study was conducted on 60
patients, divided into two age groups:
 Patients aged 8-12 years: in this group beside being investigated,
it is also used to evaluate the results of canine eruption after bone
grafting.
 Group of patients over 12 years of age: was selected to graft the
alveolar bone in the cleft area for three reasons: regeneration of the arch;
orthodontic support, preparation of implant bone foundation.

Of the 60 patients above, there were 26 male (43.4%) and 34
female (56.7%). We believe that gender differences do not affect the
evaluation results of the study.


19
4.1.2. Types of cleft
60 patients divided into 2 groups:
 Group 1: There are 25 cases with unilateral cleft, 5 cases with bilateral
cleft (16.7% of group 1), creating research group 1 with 35 clefts
 Group 2: There are 23 cases with unilateral cleft, 7 cases with bilateral
cleft (23.3% of group 2), creating research group 2 with 37 clefts.
4.1.3. Oronasal fistula
They are common complication after palate surgery in patients
with cleft lip and palat. In our study, there was not much difference in
the rate of oranasal fistula between the two study groups.
After 3 months of surgery, all fistula were closed, make up 100%
(Table 3.5), without any difference between the two study groups.
4.1.4. Canine development and eruption
In Table 3.7 of this study, the calculation for both research groups
was: cleft without canine accounted for 8.1%, there were enrupted and
erupted canine: 48.6% erupted and unerupted accounted for 43%. , 3%.
To compare eruption rate between the two groups, in our study the
development and canine eruption were classified before surgery and
monitored teething after surgery.
After 3 months: group 1 has 8.3%, while group 2 has 27.3% of
teeth come out - into the bone graft area.
After 6 months: the rate of canine eruption is 50% in group 1 and
54.54% in group 2.
After one year: the rate of canine eruption is 83.33% and group 2 is

72.72%.
Group 1 is a group of bone grafting combined with iliac bone +
PRP + bone substitutes with eruption in higher proportion. This can be
explained by the results of bone regeneration in group 1 with full bone
mass compared to group 2 that meet the necessary conditions of the
eruption process. The studies at the time, different methods but have
shown results: bone grafting is a prerequisite to create conditions for
canines erupting into the cleft. However, graft material also affects bone
regeneration results and eruption time.
4.1.5. Grafting materials
Joseph Deatherage in his research in 2010 presented grading
materials as well as their properties.


20
Properties
Osteogenesis
Osteoinduction
Osteoconduction

Material

Autologous bone
Allograft: Demineralized bone, Freeze-dried bone
Bio-Oss, Calcium phosphates, Calcium sulfate,
Collagen, Glass ionomers, Hydroxyapatite, NiTi.
Origins
Vật liệu
Alloplast
Human bone, freezed-dried bone

Ceramic
calcium sulfate, calcium phosphates, bioactive
silicate hydroxyapatite.
Growth factor
platelet-rich plasma, BMP, bioactive protein.
Bio-cells
Mesenchymal cells, autologous bone
In this study we chose the autologous bone graft material and the
iliac crest and guided material. These two materials are combined with
biological materials that have growth factors, platelet-rich plasma. With
our clinical experience, we conducted this study when combining the
iliac crest and bone substitutes for bone grafting in group 2 (before
grafting the outer shell bone mass) we combined with the ratio: The
amount of artificial bone must be less than or equal to the weight of the
porous bone itself.
4.1.6. Grafting techniques
We want to share our experiences in technique procedures:
 We found that the weakest point of the flap was the base where the
graft would be held in the position adjacent to the nasal cavity. The mucosa
in this locationis very thin, easy to be torn when elevating the flap.
 The retention incision should start from the tooth cervical,
through the mobile and attached mucosa, at the deepest point of the
buccal mucosa.
 The graft should include both cortical bone and porous bone.
Most surgeons would put the porous bone to fill the defect, then fix the
graft would the cortical at the anterior of the cleft.
4.2. BONE RESORPTION AFTER INTERVENTION WITH
AUTOLOGOUS BONE AND PRP, BONE SUBSTITUTES.
4.2.1. Pre-operative cleft morphology.
Inclusion criteria of both groups: patients participating in the study

must receive orthodontic treatment at least 6 months before the


21
scheduled time of cleft palate surgery. . This is aimed for similarities of
alveolar cleft between two groups.
Measurement before surgery: group 1 has height: 11.31 ± 1.71 and
width: 8.70 ± 2.68, while group 2 has results with height: 11.31 ± 1.81
and width: 9.93 ± 2.87 (p> 0.05). This data shows that the height and
width in group 2 are not significantly higher than in group 1 (no
difference), this might be because the age group> 12 years of group 2 is
higher. group 1 (66.7% compared to 60%). This difference will allow us
to investigate bone resorption rate after surgery with reliable results.
4.2.2. Results after intervention with autologous bone and PRP, bone
substitutes.
A. Results after 1 week:
In this study, after 7 days of intervention, the rate of good results in
group 1 (93.3%) is higher than that in group 2 (83.3%), but this
difference is not statistically significant (p > 0.05) maybe the sample
size is not big enough. Although the surgery results in the first 7 days
are related to many factors, especially the skills of the surgeon. But this
study was conducted in a surgical department, the same group of
surgeons, with a result of up to 10% difference showed the effectiveness
of the presence of PRP in the graft material.
B. Bone resorption
According to Mooren in the second week, many inflammatory cells
begin to appear, as well as moderate signs of bone resorption in the
bone graft itself. Accompanying it is the presence of osteoclasts. By the
6th week after bone grafting: there was no sign of inflammation in the
graft area. Few signs of bone grafts have been identified. The bone mass

at this time is greatly reduced compared to the first week after bone
transplant. At 12 weeks post-graft: there is no sign of inflammation in
the graft area. Only a few signs of the graft bone are seen, but the
boundary between the new bone and the new bone cannot be
determined. The slices through the graft do not see empty spaces. The
bone resorption from week 6 to week 12 is much less than the period
from week 2 to week 6.
At 3 months after surgery in group 1, the bone height was measured
9.88 ± 1.76 compared to the baseline height 11.31 ± 1.71 with the rate
of bone resorption recorded as 12.54 ± 9.45%. In the second group, the
bone height was measured at 8.59 ± 2.21so with the baseline height of


22
11.31 ± 1.81 with the bone resorption recorded as 23.68 ± 16.54%. Thus,
group 2 is a group that only uses iliac bone grafting. The bone
reesorption is twice than that of group 1 using iliac bone graft material
+ PRP + bone substitutes.
At 6 months after surgery in group 1, the bone height measured
9.07 ± 2.57 compared with 3 months after surgery, the bone resorption
rate was recorded as 9.80 ± 18.46% . In the second group, the bone
height was 7.72 ± 3.33 compared with 3 months after surgery, the rate
of bone resorption was recorded as 13.18 ± 2.70%. This result shows
that the bone resorption was greatly reduced during this period. The
difference in bone resorption level between the two groups is not
significant. We think that this healing period only has the impact of
artificial grafting materials, but they have also been regenerated in most
of the graft, so the effect of osteoconduction and bone resorption is also
significantly decreased.
And at the time of 1 year after surgery in group 1, the bone height

was measured 7.60 ± 2.15 compared to 6 months after surgery, the bone
resorption rate was recorded as 15.35 ± 10.95. %. In the second group,
the bone height was measured at 6.52 ± 3.39 compared to 6 months
after surgery. The bone resorption rate was recorded at 21.22 ± 29.71%.
This period is stable with no regeneration activity in the grafting area,
but the research results show that bone resorption is still happening, to a
significant extentsion, but there is still a difference in bone resorption.
between the two research groups. This difference is due to the
composite material (artificial) due to its slow-digesting properties. After
1 year of grafting, the bone resorption rate, compared to the bone height
in test group accounted for 32.67 ± 17.84% and group 2 was 41.86 ±
29.61. Thus, the average bone height achieved in group 1 is 68% (3/4 of
the needed height) to achieve a type II bone grading according to
Bergland's scale, while that of group 2 is only 58%.
Finally, the differences in postoperative failure rates between the
two study groups were significant. The test group only had 2 patients
having secondary surgery, accounting for 6.6%. While the control group
had 5 patients having a secondary surgery, accounting for 16.6%. This
is also clear evidence to show the effectiveness of PRP and bone
substitute in combination with autologous bone for alveolar cleft graft.


23
CONCLUSION
Through this study, we have the following conclusions:
1. Alveolar cleft morphology and related factors.
 Alveolar cleft is a discontinuity of the maxillary dental arch. Due
to the continuous loss of the lip muscle, the impact of the tongue on the
cleft area and the asymmetry of the muscles that adhere to the maxillary,
along with the development of the patient's body, the anatomical form

of the this defect is very various. Not only the gap is wide or narrow,
but also due to the healthy side often develops in the posteroanterior
direction and rotates outward (in the same direction). And the alveolar
on the cleft side develops towards the healthy side and posteriorly. This
causes the dental arches on both sides of the gap to be asymmetrical.
This anatomical deformation is highly dependent on the treatment
planning from whether or not there was cleft lip or palate repair
treatment, and whether or not orthodontic treatment was performed
before grafting.
 The discontinuity anatomical deformity of the dental arch effects
the teeth in the gap, resulting in abnormal changes in the formation and
eruption process, especially with the lateral incisors and canines.
 Patients with alveolar cleft often have complications after cleft
palate repair, such as oronasal fistula.
 The recommended age for alveolar bone grafting is 8 to 12 years
old. At this age the maxilla develops anteroposteriorly and so the bone
grafting will not effect this growth, moreover grafting bone helps the
maxilla continue to grow in vertical direction. It also helps the teeth on
the gap to erupt at the right time.
 The alveolar cleft grafing in patients after lip and palate repair is
a technique that contributes to the closure of the oronasal fistula with
high success.
 Alveolar cleft grafting help to reconstructmorphological structure
of maxilla in the both volume and quality. Not only does it create
conditions for the teeth in the gap to erupt at the right time, but also
create treatment steps for patients to continue orthodontic treatment,
restorations for implant, prosthodontic and orthognathic surgery.


24

2. Bone resorption after intervention with autologous bone and PRP,
bone substitutes
 Alveolar grafting with autologous bone and PRP, bone substitutes
is a safe procedure with little complications.
 PRP extraction procedure can be performed at the same time with
surgery. It is also simple and safe with complication-free.
 PRP with high concentration of platelet. The growth factors
released by platelet play important roles in anti-inflammation,
stimulation of angiogenesis, so that it promotes the healing process.
They are also stimulating the bone cell differentiation and bone
regeneration.
 The bone substitutes help to make a scaffold for bone growth
and to limit the bone resorption
 At the first 3 months, the intervention show a significant
reduction in bone resorption After 6 months, the bone at the graft site
has qualified for the next steps of treatment such as: orthodontics,
prosthodontic, implant, or orthognathic surgery.
SUGGESTION
1.In the future, research on stem cell in alveolar cleft grafting
should be conducted.
2.Research on the impact of alveolar cleft grafting on the
development of maxilla, as well as the total face should be carried out.
3.Only a small proportion of alveolar cleft patients has been treated
properly. National announcement should be made so that patients and
their family can have knowledge and proper treatment.