The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial
Phase: NA
Conditions: Class III Malocclusion
Sponsor: Cairo University

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The assessment of maxillary stability in Bimaxillary orthognathic patients treated by 
mandible-first approach versus maxilla-first approach; Randomized controlled clinical 
trial. 
 
 
 
 
 
Department of Oral and Maxillofacial Surgery, Faculty of Oral & Dental Medicine, Cairo University
 
In partial fulfillment of the requirements for the Doctorate degree
 
 
 
 
 
 
 
 
 
Submitted by:
 
Mohamed Hamdy Mahmoud Ismail
 
B.D.S 2010
 
M.D.S 2016
 
Faculty of Oral & Dental Medicine
 
Cairo University
 
23\11\2017 
 
 
 
 
 
 
 
 

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Title: 
The assessment of maxillary stability in Bimaxillary orthognathic patients treated by mandible-first approach versus maxilla-first approach; 
randomized controlled clinical trial. 
Trial registration: 
The study is to be registered on ClinicalTrials.gov 
Organization:  CairoU 
User Name:     MHamdy 
Registration no:  
Protocol version: 
SPIRIT 
Funding: 
Self-funding 
Roles and responsibilities: 
1. Ass. Prof. Dr. Niven Askar (NA) 
 Assistant Professor of Oral and Maxillofacial Surgery - Cairo University 
 The senior supervisor  
 Assessment of the procedures  
2. Dr. Tarek El-Faramawi (TF) 
 Lecturer Oral and Maxillofacial Surgery - Cairo University 
 Assistant supervisor 
 Sequencing generation  
 Surgical procedures  
3. Dr. Mohamed Hamdy (MH)  (Principle  Investigator) 
 
Assistant Lecturer of Oral and Maxillofacial Surgery - MSA University 
 
Researcher 
 
Data collection  
 
Assisting in the surgical procedures 
 
Follow up with the patients 
  
Introduction: 
The rehabilitation of function, esthetics and stability are the objectives of any orthognathic surgery. The long term stability of the surgical 
procedures which has been the research target in the recent years is affected by the direction of the surgical movement.(Venkategowda et al., 
2017) 
Bimaxillary orthognathic surgery is important to manage a wide range of abnormalities related to the jaws. The regular method of performing 
Bimaxillary surgery has always been to start repositioning the maxilla first, stabilize it, and then reposition the mandible. However, the 
revolution in methods of rigid internal fixation has allowed the change in this traditional sequencing whereby the mandible is repositioned and 
stabilized first, followed by maxilla repositioning.(Perez and Ellis, 2011) 

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Many surgeons believe that in Bimaxillary surgery one jaw has to be repositioned and stabilized first before repositioning of the second jaw. 
Back in the days of internal wire fixation, the maxilla was the only jaw that could be adequately stabilized. Therefore the maxilla was 
repositioned and stabilized first as an initial and regular step in bimaxillary cases. The factor that has allowed surgical repositioning of the 
mandible first is the existence of stable internal fixation devices (plates and/or screws). As a result, if the mandible is to be repositioned first, it is 
essential to perform stable rigid internal fixation.(Perez and Ellis, 2011) 
There are some essential requirements to perform the mandible first surgery. The most important one is the need to achieve stable internal 
fixation of the mandible after the osteotomy. The factor that allowed repositioning of the mandible as an initial surgical step is the availability 
and existence of stable internal rigid fixation.(Béziat et al., 2009) 
(Park et al., 2015) reported that in patients of skeletal class III who underwent bimaxillary orthognathic surgery with surgery first approach had a 
relapse rate of 57.9%. While patients treated by the conventional three stage method had a 26.3% relapse rate 
The main advantage of performing the mandible first is eliminating the greater error in malocclusion and condylar position that occur after 
performing the maxilla first. Thus by following the mandible first sequence the surgeon can achieve a stable occlusion with minimum 
errors.(Perez and Ellis, 2011) 
Objective of the study: 
To find out if the mandible-first approach provides a stable maxilla than the traditional maxilla first approach  
 
Trial design: 
Double-blinded randomized controlled clinical trial 
 
Materials and Methods: 
Study setting: 
Outpatient clinics of the Department of Oral &Maxillofacial surgery, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt 
Eligibility criteria: 
Inclusion Criteria for participants: 
1. Patients with skeletal class III malocclusion  requiring bimaxillary orthognathic surgery 
2. Patients free from any systemic disease 
3. Patients who approved to be included in the trial and signed the informed consent 
4. Patients with no signs or symptoms of temporomandibular disorders.  
 
 Exclusion criteria for participants: (Ritto et al., 2014) (Liebregts et al., 2017) (Jun-Young Paeng 2012) 
1. Patients with cleft lip and palate “can have an unfavorable effect on facial growth (LARRY M. WOLFORD, 2002)” 
2.   Patients receiving chemotherapy or radiotherapy “due to the risk of low bone quality and healing (JW, 2003) “ 
3.   Patients who refused to be included in the trial 
 
Interventions: 
a) Diagnosis 
All patients are diagnosed and selected according to inclusion and exclusion criteria 
Comprehensive clinical examination and understanding of patient’s chief complains and needs. 
Standard preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion) 
Primary alginate* upper and lower impressions are made for the selected patients to make dental models 
Bite registration is obtained by modeling wax**.  
Cone beam computed Topography (CBCT) *** with 3D photogrammetry imaging of the patient wearing their wax bite.  
 

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b) Surgical planning 
Group I diagnostic data are used for computer-aided planning & designing the computer aided surgical waver (figure A) to check the final 
position of the maxilla first then the mandible and condyle in the planned position using specialized software† 
Group II diagnostic data are used for computer-aided planning & designing the computer aided surgical waver to check the final position of the 
mandible first and the condyles then the maxilla in the planned position using specialized software 
 
Figure A shows the surgical waver (Vale F and Maló L, 2016)  
c) Intra-operative procedures: 
Local anesthesia is injected intraorally along the incision line. 
Scrubbing and draping of the patient are carried out in a standard fashion. 
A vestibular intraoral incision for maxilla & Sagittal split incision for mandible are carried out. Dissection and reflection to reach the bone  
Maxillary & mandibular osteotomies are carried out.  
Complete mobilization of maxillary and mandibular segments 
Reposition and fixation of the maxillary & mandibular segments using the surgical waver 
The incisions are closed with continuous mattress absorbable sutures¥. 
d) Postoperative 
Patients will start antibiotics 4 hours after the last intraoperative dose (Amoxicillin / Clavulanic acid 625 mg every 8 hours) for 5 days 
Patients will start analgesics (NSAIDs every 6 hours) for 3 days 
Mouthwash (Chlorhexidine 0.12%) will be prescribed for 2 more weeks. 
e)  Strategies to improve adherence to intervention 
Postoperative orthodontic treatment is necessary after the operation to obtain the final stable occlusion 
f) Concomitant care 
None needed 
g) Follow up & Evaluation 
 Post-operative treatment is started immediately postoperative (4 hours) 
 The patients are scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months 
 At 1 week and 6 months postoperatively CBCT using same parameters is ordered to calculate the difference between the immediate post-
operative and the late post-operative results. (Ritto et al., 2014) (Liebregts et al., 2017) (Jun-Young Paeng 2012, J. Valladares-Neto et al., 
2013) 
 Patients are referred back to the orthodontist to receive his postsurgical orthodontics 
 The technique is evaluated by applying hard tissue parameters to compare the immediate post-operative (P0) with the late postoperative 
result (P1) using 3D Cephalometry and image fusion 
 
 
 

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Outcomes: 
Type of outcome 
Outcome 
Measuring tool: 
Unit: 
Primary outcome:  
Maxilla stability 
Cone 
beam 
computed 
tomography (cbct) (Ann et 
al., 2016) 
mm 
Secondary outcome: 
Patient satisfaction 
Questionnaire(Rustemeyer 
et al., 2010) 
numerical 
 
Participant timeline: 
 
 
Study Period 
Enrollment 
Allocation 
Post-allocation 
Close-out 
Time Point 
-t1 
0 
t1 
t2 
t3 
t4 
t5 
Enrolment: 
 
 
 
 
 
 
 
Eligibility Screen 
9\2017-
9\2018 
 
 
 
 
 
 
Informed Consent 
1 week after 
eligibility of 
candidate 
 
 
 
 
 
 
Pt. preparation 
 
 
After consent 
signature 
 
 
 
 
 
Interventions: 
 
 
 
 
 
 
 
Planning and surgical 
guide fabrication  
 
 
1 week after 
patient 
preparation 
 
 
 
 
Surgical procedure   
 
 
 
1-3 months 
after start 
of planning 
 
 
 
Postoperative 
CBCT 
scans 
 
 
 
 
1-3 weeks 
after 
surgery 
 
 
Assessments  
 
 
 
 
 
 
 
Superimposition, data 
collection 
and 
statistical analysis 
 
 
 
 
 
6 
months 
after surgery 
 
Editing and closing  
 
 
 
 
 
 
6 
months 
after surgery 
 
 
Sample size:  
The aim of this study is to assess the stability of mandible-first and the traditional maxilla-first approach.  Based on the previous paper by 
(Esteves, 2014) and (Venkategowda, 2017), If there is truly no difference between the immediate post-operative and late post-operative, then 12 
patients in each group are required to be 80% sure that the limits of a two-sided 95% confidence interval will exclude a difference in means of 
more than 1.5. 
Statistical methods:  
Data management and Statistical analysis will be done using Statistical Package for Social Sciences, Version 21.0 (SPSS, IBM) for Windows.  
Numerical data will be expressed as mean and standard deviation (SD).  Comparisons between 2 measurements will be done by paired t test.  
Comparisons between 2 groups will be done by independent t test or Mann Whitney test. P value<0.05 will be considered significant. All tests 
will be two tailed. SD = 1 
 

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Recruitment: 
Outpatient Clinics of department of Oral & Maxillofacial Surgery in Faculty of Oral and Dental Medicine are screened, screening will continue 
until the target population is achieved.   
 
Recruitment Strategy: 
The Outpatient Clinics of department of Oral & Maxillofacial Surgery in Faculty of Oral and Dental Medicine utilizes "Patient Lists" for 
identifying and recruitment of potential subjects to the research. Once identified in the database, patients potentially eligible for this study are 
contacted by MH who explains the study and ascertains the patient’s interest. If interested, the patient is seen in the clinical research clinics 
where more detailed evaluations and preparations are made. (Appendix A) 
 
 
 
Allocation:  
Sequence generation: 
Participants are randomly assigned by MH and TF to either control or interventional group with a 1:1 allocation. 
Allocation—concealment mechanism  
Participants are randomized by MH and TF. Allocation concealment is ensured, as the service will not release the randomization code until the 
patient has been recruited into the trial.  
Allocation—implementation 
All patients who give consent for participation and who fulfill the inclusion criteria are included and randomized. Randomization is done by TF. 
In return, TF will send an answer form to NA who is not involved in assessing outcome of the study. This form will include a randomization 
number. In every surgery closed envelopes with printed randomization numbers on it will be available. For every randomization number, the 
corresponding code for the surgical stent group of the randomization list will be found inside the envelopes. 
NA will open the envelope and will find the type of surgical approach to be conducted in this patient. 
MH is not allowed to receive information about the group allocation.  
The allocation sequence will be generated by computer sequence. Throughout the study, the randomization will be conducted by TF in Oral & 
Maxillofacial Surgery department in order to keep the data management and the statistician blind against the study condition as long as the data 
bank is open. 
The randomization list remains with TF for the whole duration of the study. Thus, randomization will be conducted without any influence by 
MH. 
Blinding: 
Assessments regarding clinical recovery will be conducted by TF blind to treatment allocation. Due to the nature of the intervention, MH cannot 
be blinded to allocation, but are strongly instructed not to disclose the allocation status of the participant at the follow up assessments. NA will 
feed data into the computer in separate datasheets so that MH and TF can analyze data without having access to information about the allocation. 
 
Data Collection methods:  
Primary Outcome: 
Maxillary Stability: 
Maxillary stability is assessed using cone beam computed tomography (CBCT) (Ann et al., 2016). In this study linear deviation between the 
immediate post-operative and the late post-operative positions will be calculated using mimics computer software. Where; the early and late 
post-operative CBCTs are superimposed by means of the reference markers 
Secondary Outcome: 
Patient Satisfaction: 
Patient satisfaction (Rustemeyer et al., 2010) is assessed through the questionnaire answered by the patient preoperatively at T0 and 6 months 
postoperatively.  
 
 

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Data collection, management and analysis: 
 
Data is collected by TF & MH 
Accuracy of the mandibular and maxillary approaches: 
 The angular and linear measurement differences (ΔT) between the immediate post-operative (P0) and the late postoperative result (P1) are 
calculated using the CBCT cuts. 
 9 hard tissue landmarks (CoLt, left condyle; CoRt, right condyle; UI, upper incisor; LI, lower incisor; Me, menton; MnMLt, first mandibular 
molar on left side; MnMRt, first mandibular molar on right side; MxMLt, first maxillary molar on left side; MxMRt, first maxillary molar on 
right side), and 3 hard tissue planes (Maxillary, Mandibular & occlusal) are analyzed systematically with respect to the 3D facial coordinates 
(MidFacial plane MFP, Frankfort horizontal FHP, and coronal plane CP) to obtain linear and angular measurements. (B. Li et al., 2013; Zinser et 
al., 2013) (Appendix B) 
 In order to assess inter-observer reliability, 2 maxillofacial surgeons performed the linear & angular analyses. In order to assess intra-observer 
reproducibility, each assessor made 2 sets of recordings. Both 
 Reliabilities are qualified using Pearson’s intra-class correlation coefficient test giving a value between +1 and −1 inclusive, where 1 is total 
positive correlation, 0 is no correlation, and −1 is total negative correlation. 
 
Data management  
Data Forms and Data Entry 
All data are entered electronically by TF and MH. Original study forms will be entered and kept on file at the participating site.  
Participant files are to be stored in numerical order and stored in a secure and accessible place and manner. Participant files are maintained in 
storage for a period of 1 year after completion of the study. 
 
Data Transmission and Editing  
The data entry screens resemble the paper forms approved by the Protocol Chair Assistant Professor. 
 
Security and Back-Up of Data  
All forms and videos related to study data are kept in locked cabinets by MH. Access to the study data is restricted. A complete back up of the 
primary database is performed twice a month. Back-ups of periodic data analysis files are kept.  
 
 
Harms 
The possible adverse effects of the procedure include 
1. inaccurate translation of surgical plan which is managed by elastics  
2. numbness to the lower lip which is temporary for a duration of 3-6 months and is managed by vitamins 
3. Pain which is temporary and managed by analgesics 
 
Auditing 
Auditing will be done in thesis defense session 
 
Ethics and dissemination: 
Research ethics approval 
This protocol and the template informed consent form is reviewed by the Ethics Committee of Scientific Research - faculty of oral and dental 
medicine – Cairo University 
Protocol amendments 
Any modifications to the protocol which may impact on the conduct of the study, potential benefit of the patient or may affect patient safety, 
including changes of study objectives, study design, sample sizes, study procedures, or significant administrative aspects will require a formal 
amendment to the protocol. Such amendment will be agreed upon by the Council of oral and maxillofacial surgery department 
Consent or assent 

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Introduction of the trial and discussion with the patient is carried out by MH. The purpose, the nature of this study and detailed surgical 
procedure with possible complications is also discussed. Patients are then being able to have an informed discussion with the NA. Written 
consent from patients willing to participate in the trial is obtained by MH. All, consent forms have been translated into Arabic (Appendix C) 
 
Confidentiality  
All study-related information is stored securely by MH. All participant information is stored in locked file cabinets in areas with limited access. 
All patients’ records are digitized and stored securely on MH personal computer. 
Declaration of interests 
The study is self-funded and there is no conflict of interest to declare 
Access of data 
MH, TF, and NA are given access to the data sets. All data sets are password protected. To ensure confidentiality, data dispersed to project team 
members are blinded of any identifying participant information. 
 
 
Ancillary and post-trial care  
All patients are followed up until complete healing and satisfactory reconstruction results occur by MH 
 
Dissemination policy  
Study results are published as partial fulfillment of the requirements for PHD degree in Oral and maxillofacial surgery by MH. 
Topics suggested for presentation or publication are circulated to the authors. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendices 
Appendix A: Diagnostic chart 
Mandible-first Project 
Diagnostic chart 
Patient No. …….. 
Name: ______________________________________________________ 
Age: ________                                         Date of birth: 
Sex: _______________ 
Weight: _______________                     Height: ____________ 
Occupation: _________________ 
Address: _________________________________________________ 
Contact No.: _____________________________________ 
 
 
 
Chief Complain: 
 
 
 
 
 
Type of dentofacial deformity 
 
Class III 
 
 
 
other; mention _____________________ 
__________________________________ 
 
 
Medical history 
…………………………………………………………………………………………………………………
….. 
…………………………………………………………………………………………………………………
….. 

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TMJ examination 
History of signs and symptoms 
 
 
 
Clinical examination of TMJ 
 
 
 
 
Protrusive 
 
 The joint area 
 Muscles of mastication 
1. Masseter 
2. Temporalis 
3. Medial pterygoid 
4. Temporalis tendon 
5. Functional manipulation of lateral pterygoid 
 
 
 
 
 
 
 
Appendix B: Assessor chart 
 
Assessor 1 
Assessor 2 
Distance from Frankfort horizontal plane 
(mm) 
Me 
MnMLt/MnMRt 
LI 
MxMLt/MxMRt 
UI 
CoLt/CoRt 
 
 

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Distance from coronal plane (mm) 
Me 
MnMLt/MnMRt 
LI 
MxMLt/MxMRt 
UI 
CoLt/CoRt 
Distance from midfacial plane (mm) 
Me 
MnMLt/MnMRt 
LI 
MxMLt/MxMRt 
UI 
CoLt/CoRt 
Plane angulation relative to Frankfort 
horizontal (°) 
Maxillary plane 
Mandibular plane 
Occlusal plane 
Plane angulation relative to midfacial plane 
(°) 
Maxillary plane 
Mandibular plane 
Occlusal plane 
Plane angulation relative to coronal plane(°) 
Maxillary plane 
Mandibular plane 
Occlusal plane 
 
 
 
 
 
 
 
 

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Appendix C: 
 
Consent 
 
 
Patient name:  
Age:  
Address:  
 
 
I have approved to be enrolled in this research project and the researcher has explained all the 
surgical procedure and its expected outcomes and common complications that could happen and their 
management 
 
 
.  
Patient signature                                        Researcher signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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