Hemifacial MicrosomiaNCT03869021
Computer Guided for Mandibular Distraction Osteogenesis
A study testing 3D printed surgical guide constructed and free hand surgery in people with Hemifacial Microsomia, run by Yasser Mohamed Nabil Ahmed Khirat El Hadidi at 1 site in Egypt.
Trial summary
Objectives: Distraction Osteogenesis is an integral part in management of mandibular defects associated with Hemifacial Microsomia (HFM) and post-ankylotic mandibular defects. The most difficult part in distraction osteogenesis is the prediction of distraction vector and risk of injury to vital structures as inferior… Read more about this study
- Who is it for?
- Ages 5 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemifacial Microsomia
- What is being tested?
- 3D printed surgical guide constructed and free hand surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2015to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients free from any disease affecting bone formation of both sexes was included in the study.
- Patients younger than 25 years old.
- Patients included in the study were hemifacial microsomia
- Distraction range was between 15-20 mm.
Who cannot join
- The presence of uncontrolled systemic disease.
- Previous radiotherapy on head and neck region.
- Chemotherapy within the past 12-month period.
- An active infection at the distraction site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technical Notes on Novel Technique and Step by Step Construction of Computer Guided for Mandibular Distraction Osteogenesis
Objectives: Distraction Osteogenesis is an integral part in management of mandibular defects associated with Hemifacial Microsomia (HFM) and post-ankylotic mandibular defects. The most difficult part in distraction osteogenesis is the prediction of distraction vector and risk of injury to vital structures as inferior alveolar. The current study aimed to present Three-Dimensionally Constructed Computer Guided Splints in Distraction Osteogenesis to get an ideal vector and minimal risk of vital structures injury.
Methods: The study presents computer-guided distraction osteogenesis surgery using prefabricated splints.
Read the detailed description
The current study was performed on a case control trial of patients complaining of hemifacial microsomia.. The research was reviewed by the ethical committee of the authors institute (approval number: 392, date: 30/12/2015). Written informed consent for the case to be published (incl. images, case history and data) was obtained from the patients for publication of this case report, including accompanying images In order to accurately analyse the patients' condition and formulate an optimal treatment plan, a pre-operative CBCT scan was performed using i-CAT CBCT scanner (Imaging Sciences International, Hatfield, PA, U.S.A).
Each patient was positioned in the machine and imaged at the same manner according to the recommendations of CBCT manufacturer. The Frankfurt plane was positioned parallel to the horizontal plane and the midsagittal plane was perpendicular to the horizontal plane.
The CBCT scan was required to fulfill the following criteria:
- Showing the full bony facial structures, extending from at least the inferior border of the mandible to the supraorbital ridge.
- CBCT scan should be free from any motion artifacts.
- Patient biting on cotton rolls in order to free the occlusion.
- A scan of optimum quality and resolution. (0.25 mm voxel size) IV. Virtual Treatment Planning
- The data from the CBCT scan were exported from the i-CAT Vision software in DICOM format, which was in turn imported into Mimics Medical 19.0 software (Materialise NV, Technologielaan 15, 3001 Leuven, Belgium) for virtual treatment planning.
- Using the "Thresholding" tool, the range of gray value sets is chosen to highlight the mineralized structures and separate them from the rest of soft tissue structures in the scan creating a new mask.
- Using the "Calculate 3D" tool on the new mask, a 3D rendering of the facial mineralized structures is created and is then refined using the "Smoothing" and "Wrap" tools.
- In order to properly orient the patient's head position, analyze the deficiencies, and standardize the planning process, the Frankfort Horizontal plane and the Midsagittal plan were constructed. Frankfort Horizontal Plane was defined by marking the right and left Orbitale, and the Porion of the non-affected side. The Midsagittal plane was defined by marking the Sella, the Nasion, and the Anterior Nasal Spine.
- Using the "Multiple Slice Edit" and "Region Growing" tools when needed, the jaws are separated and the mandible and maxilla are segmented separately.
- Using the "Distraction Wizard", an appropriate distraction type is selected. A distractor is selected and placed on the proposed site for distraction. The osteotomy and vector are visualized and the distractor is activated. This process is repeated until the final outcome is satisfactory. The ideal final outcome is when the canted occlusal plane is corrected and the mandibular midline is coincident with the facial midline simultaneously.
- Using the "Cylinder" tool in the "Medcad" menu, virtual distractor pins and osteotomy disk are drawn to match our selected custom-made distractor. The number of pins, their size, and orientation differed according to the vital structures in each distraction site. Hence, custom-made distractors were used. Guide fixation screws are also added to provide further retention for the guide when needed. The fixation screws, osteotomy and distractor pins are placed so as to avoid injury to any vital structures as the Inferior Alveolar Nerve, tooth buds, and dental roots .
- Using different Boolean operation, the body of the final guide is designed to fit over the bones and teeth and incorporate the different distractor components. It is then exported into STL format.
- The exported STL file is printed with Formlabs Form 2 stereolithography (SLA) 3D printer (Formlabs Inc. Somerville, MA 02143 USA) using Clear Photopolymer resin (FLGPCL02). The finished printed model is then checked for fit with the distractor.
- Prior to surgery, the guide is submerged in a basin containing 2.4% activated glutaraldehyde solution (Cidex) for 20 minutes for high level disinfection.
Surgical Procedure
- The patient was placed in supine position. General anesthesia was administered through Naso-Tracheal intubation. A cannula was inserted in a peripheral vein (18G) and normal saline infusion was started at a rate of 6 ml/kg along with Ringer's solution.
- Anesthesia was induced with IV propofol 1.5-2 mg/kg, fentanyl 1.3 μ/kg and succinyl choline 1mg/kg to facilitate nasotracheal intubation using armored tube. Anesthesia was maintained with isoflurane in oxygen and atracurium in a dose of 0.3-0.6 mg/kg.
- The surgical sites were prepared with povidone iodine and then draped according to the standard oral and maxillofacial surgery operating room procedures.
- An Antibiotic dose of 1 gm Cefotaxime vial was administered followed by Dexamethasone phosphate (as sodium salt) 4 mg vial through peripheral IV route at the beginning of the procedure. A local anesthetic solution of Articaine 4% containing Epinephrine (1:200,000) was infiltrated along the proposed operative field for hemostasis.
- A three-line pyramidal incision was performed. The distal incision was carried buccally across the external oblique ridge, and then joined to a gingival incision running buccally around the necks of the teeth on which the guide rests. The releasing incision is carried in a curved manner inferiorly and anteriorly, keeping in mind not to extend to the area of the mental foramen. Reflection of the flap was done with a periosteal elevator beginning from under the periosteum of the anterior buccal incision, working parallel to the gingival margin to detach the papillae and push distally.
- Once the field of interest was exposed, the guide was introduced onto the bone and teeth, and moved until a tight fit was achieved throughout its fitting surface. When needed, the guide was secured to the underlying bones by 2.0 miniscrews placed through their preplanned guiding tubes.
- Via a small stab incision through the skin, a transbuccal trochar is introduced, through which the self-drilling extraoral distractor pins are passed. The pins are inserted into the mandible at their designated points of entry through the guide.
- Using a piezotome, the osteotomy line is marked and the osteotomy is initiated guided by the osteotomy slit in the guide. The fixating screws and the guide are then removed. The use of piezotome allowed the planning of the osteotomies through the path of the inferior alveolar nerve without fear of nerve injury.
- After guide removal, the osteotomy is completed. The distractor is connected to the extraoral distractor pins and is then activated to insure free mobility of the distal segment. Once confirmed, the distractor is returned to its zero position. The flap was then repositioned and closed using 4-0 Braided Polyglycolic Acid sutures.
- Conditions
- Hemifacial Microsomia
- Being tested
- 3D printed surgical guide constructed, free hand surgery
- Keywords
- Computer guided surgery, Hemifacial Microsomia
- Medical subject headings
- Goldenhar Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed surgical guide constructedOther
A printed surgical guide ( to direct through the surgery and make results predictable), the guide is designed by Mimics 19.0, Materialise NV,Belgium and printed with self cure resin
free hand surgeryOther
A control group in which patients are randomly assigned and surgeries are planned without surgical guides and performed free handed
| Study group | Role | What they receive |
|---|---|---|
| Computer guided surgery | Active comparator | A surgical guide is 3d printed to guide through the surgery, the patients of this group will have the distraction surgery by a guide designed by Mimics 19.0, Materialise NV,Belgium Receives: Other: 3D printed surgical guide constructed |
| No surgical guide (free hand surgery) | Other | control group added to investigate the effect of surgical guide Receives: Other: free hand surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard cephalometric parameters of cosmetic improvement will be assessed in Degree (0) unit
The surgery of distraction osteogenesis is unpredictable the aim of use of computer planning is to make the surgery predictable to improve cosmetic results. the results will be by fixed radio graphic parameters as SNA, ANB to evaluate improvement in mandibular position, mandibular plane angle and smile orientation for occlusal cant assessment, H-angle and position of H-line to assess the retrognathia of chin all measurment will be done in degree unit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start30 Dec 2015
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemifacial MicrosomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasser Mohamed Nabil Ahmed Khirat El Hadidi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasser Mohamed Nabil Ahmed Khirat El Hadidi, Ain Shams University
- Investigators
- yasser el hadidi, mds, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869021
- Sponsor's protocol ID
- 392B
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Notes on Novel Technique and Step by Step Construction of Computer Guided for Mandibular Distraction Osteogenesis
- ClinicalTrials.gov ID
- NCT03869021
- Acronym / sponsor ID
- 392B
- Conditions
- Hemifacial Microsomia
- Keywords
- Computer guided surgery, Hemifacial Microsomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yasser Mohamed Nabil Ahmed Khirat El HadidiUniversity, hospital or other
- Study start
- 30 Dec 2015 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: Distraction Osteogenesis is an integral part in management of mandibular defects associated with Hemifacial Microsomia (HFM) and post-ankylotic mandibular defects. The most difficult part in distraction osteogenesis is the prediction of distraction vector and risk of injury to vital structures as inferior alveolar. The current study aimed to present Three-Dimensionally Constructed Computer Guided Splints in Distraction Osteogenesis to get an ideal vector and minimal risk of vital structures injury.
Methods: The study presents computer-guided distraction osteogenesis surgery using prefabricated splints.
Detailed description
The current study was performed on a case control trial of patients complaining of hemifacial microsomia.. The research was reviewed by the ethical committee of the authors institute (approval number: 392, date: 30/12/2015). Written informed consent for the case to be published (incl. images, case history and data) was obtained from the patients for publication of this case report, including accompanying images In order to accurately analyse the patients' condition and formulate an optimal treatment plan, a pre-operative CBCT scan was performed using i-CAT CBCT scanner (Imaging Sciences International, Hatfield, PA, U.S.A).
Each patient was positioned in the machine and imaged at the same manner according to the recommendations of CBCT manufacturer. The Frankfurt plane was positioned parallel to the horizontal plane and the midsagittal plane was perpendicular to the horizontal plane.
The CBCT scan was required to fulfill the following criteria:
- Showing the full bony facial structures, extending from at least the inferior border of the mandible to the supraorbital ridge.
- CBCT scan should be free from any motion artifacts.
- Patient biting on cotton rolls in order to free the occlusion.
- A scan of optimum quality and resolution. (0.25 mm voxel size) IV. Virtual Treatment Planning
- The data from the CBCT scan were exported from the i-CAT Vision software in DICOM format, which was in turn imported into Mimics Medical 19.0 software (Materialise NV, Technologielaan 15, 3001 Leuven, Belgium) for virtual treatment planning.
- Using the "Thresholding" tool, the range of gray value sets is chosen to highlight the mineralized structures and separate them from the rest of soft tissue structures in the scan creating a new mask.
- Using the "Calculate 3D" tool on the new mask, a 3D rendering of the facial mineralized structures is created and is then refined using the "Smoothing" and "Wrap" tools.
- In order to properly orient the patient's head position, analyze the deficiencies, and standardize the planning process, the Frankfort Horizontal plane and the Midsagittal plan were constructed. Frankfort Horizontal Plane was defined by marking the right and left Orbitale, and the Porion of the non-affected side. The Midsagittal plane was defined by marking the Sella, the Nasion, and the Anterior Nasal Spine.
- Using the "Multiple Slice Edit" and "Region Growing" tools when needed, the jaws are separated and the mandible and maxilla are segmented separately.
- Using the "Distraction Wizard", an appropriate distraction type is selected. A distractor is selected and placed on the proposed site for distraction. The osteotomy and vector are visualized and the distractor is activated. This process is repeated until the final outcome is satisfactory. The ideal final outcome is when the canted occlusal plane is corrected and the mandibular midline is coincident with the facial midline simultaneously.
- Using the "Cylinder" tool in the "Medcad" menu, virtual distractor pins and osteotomy disk are drawn to match our selected custom-made distractor. The number of pins, their size, and orientation differed according to the vital structures in each distraction site. Hence, custom-made distractors were used. Guide fixation screws are also added to provide further retention for the guide when needed. The fixation screws, osteotomy and distractor pins are placed so as to avoid injury to any vital structures as the Inferior Alveolar Nerve, tooth buds, and dental roots .
- Using different Boolean operation, the body of the final guide is designed to fit over the bones and teeth and incorporate the different distractor components. It is then exported into STL format.
- The exported STL file is printed with Formlabs Form 2 stereolithography (SLA) 3D printer (Formlabs Inc. Somerville, MA 02143 USA) using Clear Photopolymer resin (FLGPCL02). The finished printed model is then checked for fit with the distractor.
- Prior to surgery, the guide is submerged in a basin containing 2.4% activated glutaraldehyde solution (Cidex) for 20 minutes for high level disinfection.
Surgical Procedure
- The patient was placed in supine position. General anesthesia was administered through Naso-Tracheal intubation. A cannula was inserted in a peripheral vein (18G) and normal saline infusion was started at a rate of 6 ml/kg along with Ringer's solution.
- Anesthesia was induced with IV propofol 1.5-2 mg/kg, fentanyl 1.3 μ/kg and succinyl choline 1mg/kg to facilitate nasotracheal intubation using armored tube. Anesthesia was maintained with isoflurane in oxygen and atracurium in a dose of 0.3-0.6 mg/kg.
- The surgical sites were prepared with povidone iodine and then draped according to the standard oral and maxillofacial surgery operating room procedures.
- An Antibiotic dose of 1 gm Cefotaxime vial was administered followed by Dexamethasone phosphate (as sodium salt) 4 mg vial through peripheral IV route at the beginning of the procedure. A local anesthetic solution of Articaine 4% containing Epinephrine (1:200,000) was infiltrated along the proposed operative field for hemostasis.
- A three-line pyramidal incision was performed. The distal incision was carried buccally across the external oblique ridge, and then joined to a gingival incision running buccally around the necks of the teeth on which the guide rests. The releasing incision is carried in a curved manner inferiorly and anteriorly, keeping in mind not to extend to the area of the mental foramen. Reflection of the flap was done with a periosteal elevator beginning from under the periosteum of the anterior buccal incision, working parallel to the gingival margin to detach the papillae and push distally.
- Once the field of interest was exposed, the guide was introduced onto the bone and teeth, and moved until a tight fit was achieved throughout its fitting surface. When needed, the guide was secured to the underlying bones by 2.0 miniscrews placed through their preplanned guiding tubes.
- Via a small stab incision through the skin, a transbuccal trochar is introduced, through which the self-drilling extraoral distractor pins are passed. The pins are inserted into the mandible at their designated points of entry through the guide.
- Using a piezotome, the osteotomy line is marked and the osteotomy is initiated guided by the osteotomy slit in the guide. The fixating screws and the guide are then removed. The use of piezotome allowed the planning of the osteotomies through the path of the inferior alveolar nerve without fear of nerve injury.
- After guide removal, the osteotomy is completed. The distractor is connected to the extraoral distractor pins and is then activated to insure free mobility of the distal segment. Once confirmed, the distractor is returned to its zero position. The flap was then repositioned and closed using 4-0 Braided Polyglycolic Acid sutures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Case control trial
| Arm | Type | Receives |
|---|---|---|
| Computer guided surgery | Active comparator | Other: 3D printed surgical guide constructedA surgical guide is 3d printed to guide through the surgery, the patients of this group will have the distraction surgery by a guide designed by Mimics 19.0, Materialise NV,Belgium |
| No surgical guide (free hand surgery) | Other | Other: free hand surgerycontrol group added to investigate the effect of surgical guide |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients free from any disease affecting bone formation of both sexes was included in the study.
- Patients younger than 25 years old.
- Patients included in the study were hemifacial microsomia
- Distraction range was between 15-20 mm.
Key exclusion criteria (4 listed)
- The presence of uncontrolled systemic disease.
- Previous radiotherapy on head and neck region.
- Chemotherapy within the past 12-month period.
- An active infection at the distraction site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed surgical guide constructedA printed surgical guide ( to direct through the surgery and make results predictable), the guide is designed by Mimics 19.0, Materialise NV,Belgium and printed with self cure resin | Other | Computer guided surgery |
| free hand surgeryA control group in which patients are randomly assigned and surgeries are planned without surgical guides and performed free handed | Other | No surgical guide (free hand surgery) |
Primary outcome
Standard cephalometric parameters of cosmetic improvement will be assessed in Degree (0) unit
Time frame: 6 months
The surgery of distraction osteogenesis is unpredictable the aim of use of computer planning is to make the surgery predictable to improve cosmetic results. the results will be by fixed radio graphic parameters as SNA, ANB to evaluate improvement in mandibular position, mandibular plane angle and smile orientation for occlusal cant assessment, H-angle and position of H-line to assess the retrognathia of chin all measurment will be done in degree unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yasser el hadidi, mds principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed surgical guide constructed and free hand surgery in people with Hemifacial Microsomia, run by Yasser Mohamed Nabil Ahmed Khirat El Hadidi at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard cephalometric parameters of cosmetic improvement will be assessed in Degree (0) unit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.