Lefort I OsteotomyNCT03884699
Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency
A study testing Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant in people with Lefort I Osteotomy, run by Cairo University.
Trial summary
In Maxillary transverse deficiency, is waverless lefort I multiple pieces osteotomy using virtually planned patient specific titanium implants feasible and does it provide accuracy? This prospective case series study evaluating the postoperative outcomes and accuracy of preoperatively planned positional changes… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lefort I Osteotomy
- What is being tested?
- Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Mar 2021
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients suffering from transverse and anteroposterior maxillary discrepancy.
- Patients requiring bimaxillary orthognathic surgery.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
- Highly motivated patients.
Who cannot join
- Patients who are younger than 14 years.
- Patients having a significant systemic disease that may affect normal healing.
- Intra-bony lesions or infections that may retard the osteotomy healing.
- Patients receiving chemo or radiotherapy.
- Known allergies or sensitivities to dental materials, including Titanium or general anesthesia agents.
- Patient with bad oral hygiene.
Show all 9Show fewer
- Pregnant females.
- Inability to return for follow up visits.
- Refusal of participation from the patient.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accuracy of Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency Using CAD/CAM Patient Specific Titanium Implants (Case Series Study)
In Maxillary transverse deficiency, is waverless lefort I multiple pieces osteotomy using virtually planned patient specific titanium implants feasible and does it provide accuracy?
This prospective case series study evaluating the postoperative outcomes and accuracy of preoperatively planned positional changes together with virtually designed drilling and fixation guides for the waferless positioning and fixation of the multiple pieces Le Fort I of the maxilla using CAD-CAM designed patient-specific implants.
Read more
The purpose of this study is to develop and validate an orthognathic CAD/CAM patient specific implant together with template that can guide both the osteotomy and the repositioning of the maxilla during the correction of transverse maxillary deficiency.
Thus, the traditional model and the additional preparation for CAD/CAM surgical splints including scanning dental casts, and recording and moving virtual dental casts, were not required. The preoperative and laboratory procedures were simplified, and the intermediate splint technique was eliminated, so the associated potential errors were avoided.
Read the detailed description
The aim of this study is to evaluate the accuracy of planned waferless positioning of lefort I multiple piece osteotomy in maxillary deficient patients using CAD-CAM patient-specific implants together with virtually designed drilling and fixation guides.
Interventions
- Diagnostic procedures: All Patients will be selected according to inclusion and exclusion criteria \& Comprehensive clinical examination and understanding of patients' chief complains and needs will be carried out Preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion) Alginate Impressions† of upper \& lower jaws for acquiring diagnostic dental casts Cone Beam Computed Topography (CBCT) for the patients §
- Planning procedures:
Computer-aided planning: All planning will be done using specialized Mimics software** Import CBCT into virtual planning software. Segmentation: highlighting and selection of the bony anatomy based on bone density (Hounsfield Units).
3D reconstruction: virtual 3D model. CT scanning of the dental stone casts. Image fusion: to combine the virtual casts onto the 3D bony model to obtain a composite artifact-free skull model.
Virtual planning: based on clinical evaluation and 3D cephalometric analysis. Virtual osteotomies mimicking segmental Lefort I and a bilateral sagittal split osteotomy.
Designing the virtual cutting guide. Virtual movement into the desired positions of the segmented maxilla and mandible, based on: clinical evaluation, 3D cephalometric analysis and the desired occlusion.
Once the optimal position of the maxilla is achieved, a patient specific implant will be virtually designed to fix the segmented maxilla in its new position.
Fabrication of the cutting guide using additive manufacturing technique from polymer material.
Fabrication of PSI from titanium alloy using additive manufacturing technique.
- Intra operative procedures The surgical procedures will be carried out by RT under the supervisor of AH in the Oral \& Maxillofacial operating floor on the 8th floor of the faculty of Oral \& Dental Medicine new building.Scrubbing and draping of the patient will be carried out in a standard fashion according to Anon 2006.
Local anesthesia (lidocaine 2%, 1/100000 adrenaline) will be injected intraorally along the incision lines for hemostasis.
Access through a vestibular intraoral incision for maxilla \& Sagittal split incision for mandible will carried out. Dissection and reflection to reach the bone.
Bilateral Sagittal Split mandibular osteotomies will carried out. The osteotomy guide 2 parts will into fit the left and right side the anterior maxillary walls separately during the operation for ease of use.
Le Fort I Maxillary osteotomies will carried out using the osteotomy guide. Complete mobilization of maxillary segments. Reposition and fixation of the maxillary segments into the planned position will be done by the Patient Specific Implant (PSI) using the drilling site done by the osteotomy guide.
Reposition and fixation of the mandibular segments using bicortical screws. The incisions will be closed with continuous mattress absorbable sutures††. 4. Postoperative care \& Follow up Post-operative treatment will start immediately postoperative (4 hours) 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. The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.
At 1 to 3 weeks postoperatively CBCT using same parameters will be ordered to calculate the difference between surgical plan and actual outcome will be evaluated.
Patient will be referred back to the orthodontist to receive his postsurgical orthodontics.
- Conditions
- Lefort I Osteotomy
- Being tested
- Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant
- Keywords
- Orthognathic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implantProcedure or surgery
Virtual planning: based on clinical evaluation and 3D cephalometric analysis. Virtual osteotomies mimicking segmental Lefort I and a bilateral sagittal split osteotomy.
Designing the virtual cutting guide. Virtual movement into the desired positions of the segmented maxilla and mandible, based on: clinical evaluation, 3D cephalometric analysis and the desired occlusion.
Once the optimal position of the maxilla is achieved, a patient specific implant will be virtually designed to fix the segmented maxilla in its new position.
Fabrication of the cutting guide using additive manufacturing technique from polymer material.
Fabrication of PSI from titanium alloy using additive manufacturing technique.
| Study group | Role | What they receive |
|---|---|---|
| Segmental maxillary lefort I re-positioning | Other | Accuracy of the planned virtually re-positioned segmental Lefort I maxilla using a specifically designed patient implant, comparing the virtual plan to the actual postoperative position. Receives: Procedure: Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transverse dimension of maxilla on virtual plan and postoperative
8 Reference points will be chosen below the osteotomy line on the maxilla (4 dental and 4 bony), and the distances between these points and the Frankfort, the midfacial, and the coronal planes, to show the vertical, horizontal, and axial positions of the maxilla, respectively.
These distances will be measured on the postoperative CT data and their deviations from the virtual plan will illustrate the accuracy of our procedure.
The 4 bony reference points are :
PF: Piriform at the widest point ; J: The junction between the maxillary tuberosity outline and the zygomatic process (63); and GPF: Greater palatine foramen.
The 4 dental reference points are:
A3L: Cusp of the left maxillary canine; A3R: Cusp of the right maxillary canine; A6L: Mesiobuccal cusp of the left first maxillary molar; and A6R: Mesiobuccal cusp of the right first maxillary molar.
Measured: 1-3 months
Secondary outcomes (1)
Planning & surgical times: estimated time to the actual time
Using chronometer, the time from the start of virtual plan \& design, and the time of the surgery will be calculated.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lefort I OsteotomyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Anwar Ibrahim Taman, Cairo University
- Investigators
- Rasha Taman, Msc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884699
- Sponsor's protocol ID
- OMFS 3-3-7
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency Using CAD/CAM Patient Specific Titanium Implants (Case Series Study)
- ClinicalTrials.gov ID
- NCT03884699
- Acronym / sponsor ID
- OMFS 3-3-7
- Conditions
- Lefort I Osteotomy
- Keywords
- Orthognathic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 21 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.
In Maxillary transverse deficiency, is waverless lefort I multiple pieces osteotomy using virtually planned patient specific titanium implants feasible and does it provide accuracy?
This prospective case series study evaluating the postoperative outcomes and accuracy of preoperatively planned positional changes together with virtually designed drilling and fixation guides for the waferless positioning and fixation of the multiple pieces Le Fort I of the maxilla using CAD-CAM designed patient-specific implants.
The purpose of this study is to develop and validate an orthognathic CAD/CAM patient specific implant together with template that can guide both the osteotomy and the repositioning of the maxilla during the correction of transverse maxillary deficiency.
Thus, the traditional model and the additional preparation for CAD/CAM surgical splints including scanning dental casts, and recording and moving virtual dental casts, were not required. The preoperative and laboratory procedures were simplified, and the intermediate splint technique was eliminated, so the associated potential errors were avoided.
Detailed description
The aim of this study is to evaluate the accuracy of planned waferless positioning of lefort I multiple piece osteotomy in maxillary deficient patients using CAD-CAM patient-specific implants together with virtually designed drilling and fixation guides.
Interventions
- Diagnostic procedures: All Patients will be selected according to inclusion and exclusion criteria \& Comprehensive clinical examination and understanding of patients' chief complains and needs will be carried out Preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion) Alginate Impressions† of upper \& lower jaws for acquiring diagnostic dental casts Cone Beam Computed Topography (CBCT) for the patients §
- Planning procedures:
Computer-aided planning: All planning will be done using specialized Mimics software** Import CBCT into virtual planning software. Segmentation: highlighting and selection of the bony anatomy based on bone density (Hounsfield Units).
3D reconstruction: virtual 3D model. CT scanning of the dental stone casts. Image fusion: to combine the virtual casts onto the 3D bony model to obtain a composite artifact-free skull model.
Virtual planning: based on clinical evaluation and 3D cephalometric analysis. Virtual osteotomies mimicking segmental Lefort I and a bilateral sagittal split osteotomy.
Designing the virtual cutting guide. Virtual movement into the desired positions of the segmented maxilla and mandible, based on: clinical evaluation, 3D cephalometric analysis and the desired occlusion.
Once the optimal position of the maxilla is achieved, a patient specific implant will be virtually designed to fix the segmented maxilla in its new position.
Fabrication of the cutting guide using additive manufacturing technique from polymer material.
Fabrication of PSI from titanium alloy using additive manufacturing technique.
- Intra operative procedures The surgical procedures will be carried out by RT under the supervisor of AH in the Oral \& Maxillofacial operating floor on the 8th floor of the faculty of Oral \& Dental Medicine new building.Scrubbing and draping of the patient will be carried out in a standard fashion according to Anon 2006.
Local anesthesia (lidocaine 2%, 1/100000 adrenaline) will be injected intraorally along the incision lines for hemostasis.
Access through a vestibular intraoral incision for maxilla \& Sagittal split incision for mandible will carried out. Dissection and reflection to reach the bone.
Bilateral Sagittal Split mandibular osteotomies will carried out. The osteotomy guide 2 parts will into fit the left and right side the anterior maxillary walls separately during the operation for ease of use.
Le Fort I Maxillary osteotomies will carried out using the osteotomy guide. Complete mobilization of maxillary segments. Reposition and fixation of the maxillary segments into the planned position will be done by the Patient Specific Implant (PSI) using the drilling site done by the osteotomy guide.
Reposition and fixation of the mandibular segments using bicortical screws. The incisions will be closed with continuous mattress absorbable sutures††. 4. Postoperative care \& Follow up Post-operative treatment will start immediately postoperative (4 hours) 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. The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.
At 1 to 3 weeks postoperatively CBCT using same parameters will be ordered to calculate the difference between surgical plan and actual outcome will be evaluated.
Patient will be referred back to the orthodontist to receive his postsurgical orthodontics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Segmental maxillary lefort I re-positioning | Other | Procedure: Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implantAccuracy of the planned virtually re-positioned segmental Lefort I maxilla using a specifically designed patient implant, comparing the virtual plan to the actual postoperative position. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from transverse and anteroposterior maxillary discrepancy.
- Patients requiring bimaxillary orthognathic surgery.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
- Highly motivated patients.
Key exclusion criteria (9 listed)
- Patients who are younger than 14 years.
- Patients having a significant systemic disease that may affect normal healing.
- Intra-bony lesions or infections that may retard the osteotomy healing.
- Patients receiving chemo or radiotherapy.
- Known allergies or sensitivities to dental materials, including Titanium or general anesthesia agents.
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 |
|---|---|---|
| Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implantVirtual planning: based on clinical evaluation and 3D cephalometric analysis. Virtual osteotomies mimicking segmental Lefort I and a bilateral sagittal split osteotomy. Designing the virtual cutting guide. Virtual movement into the desired positions of the segmented maxilla and mandible, based on: clinical evaluation, 3D cephalometric analysis and the desired occlusion. Once the optimal position of the maxilla is achieved, a patient specific implant will be virtually designed to fix the segmented maxilla in its new position. Fabrication of the cutting guide using additive manufacturing technique from polymer material. Fabrication of PSI from titanium alloy using additive manufacturing technique. | Procedure or surgery | Segmental maxillary lefort I re-positioning |
Primary outcome
Transverse dimension of maxilla on virtual plan and postoperative
Time frame: 1-3 months
8 Reference points will be chosen below the osteotomy line on the maxilla (4 dental and 4 bony), and the distances between these points and the Frankfort, the midfacial, and the coronal planes, to show the vertical, horizontal, and axial positions of the maxilla, respectively. These distances will be measured on the postoperative CT data and their deviations from the virtual plan will illustrate the accuracy of our procedure. The 4 bony reference points are : PF: Piriform at the widest point ; J: The junction between the maxillary tuberosity outline and the zygomatic process (63); and GPF: Greater palatine foramen. The 4 dental reference points are: A3L: Cusp of the left maxillary canine; A3R: Cusp of the right maxillary canine; A6L: Mesiobuccal cusp of the left first maxillary molar; and A6R: Mesiobuccal cusp of the right first maxillary molar.
1 secondary outcome
Planning & surgical times: estimated time to the actual time
Time frame: 1-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Lefort I Osteotomy
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.
Rasha Taman, Msc principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant in people with Lefort I Osteotomy, run by Cairo University.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif Hassan, PhD (00201001932020, sherif.ali@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transverse dimension of maxilla on virtual plan and postoperative (time frame: 1-3 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 21 Mar 2019.