ApertognathiaNCT03277443
Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite
A study testing Computer guided surgery, Conventional model surgery and 2D cephalometric radiograph in people with Apertognathia, run by Ammar Ribhi Abu shama.
Trial summary
In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical outcomes and accuracy versus conventional model surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apertognathia
- What is being tested?
- Computer guided surgery, Conventional model surgery and 2D cephalometric radiograph
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2018to 30 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from skeletal open bite caused by vertical posterior maxillary excess and/or short mandible ramus.
- Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
- Required two jaws orthographic surgery
Who cannot join
- Patients with any systemic disease that may affect normal healing
- Intra-bony lesions or infections that may retard the osteotomy healing.
- Patient with bad oral hygiene.
- Uncontrolled Diabetes mellitus.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite: A Randomized Clinical Trial
In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical outcomes and accuracy versus conventional model surgery
Read the detailed description
P Adult Patients with skeletal open bite.
I Computer guided surgery.
C Conventional articulating model surgery
O Outcome measure:
Outcome Name Measuring Device Measuring Unit (mm)
O1 Accuracy
Computer guided: Super-imposition of virtual surgery over the post- operative CT Scan composite models ( millimeter mm)
Conventional : Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion ( millimeter mm)
O2 Anterior open Bite Closure
Standardized Multi Scan CT (millimeter mm)
- Conditions
- Apertognathia
- Being tested
- Computer guided surgery, Conventional model surgery, 2D cephalometric radiograph, 3D computerized tomography
- Keywords
- Skeletal open bite
- Medical subject headings
- Open Bite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided surgeryProcedure or surgery
Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.Craniofacial images from 3D computerized tomography (3D-CT scan) can be used to create a 3D model, which can in turn be used for 3D Cephalometry measurements and surgical simulation.The process of 3D-model contains mounting of 3D virtual models in a 3D virtual articulator; and repositioning of 3D virtual models according to the STO then Fabrication of a 3D virtual intermediate surgical wafer; and materialization of the surgical wafer using a stereolithographic technique. The 3D model can produce actual movement of surgical cuts and movement of segments accordingly
Conventional model surgeryProcedure or surgery
preparation for orthognathic surgery which involves diagnosis with 2D cephalometric radiograph, face-bow transfer and model surgery on plaster dental cast, and fabrication of intermediate and final occlusal splint.
2D cephalometric radiographDevice
2D cephalometric radiograph
3D computerized tomographyDevice
3D computerized tomography
| Study group | Role | What they receive |
|---|---|---|
| Conventional Model Surgery | Active comparator | Lateral Cephalogram with analysis and tracing of facial profile.
Modified model surgical tecnique:
1. Obtain wax bite registration.
2. Record face-bow transfer.
3. Duplication of articulating model for surgical simulation.
4. Measure all casts and bases in standard model surgery fashion.
5. Fabricate intermediate splint \& Final splint.
6. Condylar repositional splint. Receives: Procedure: Conventional model surgery; Device: 2D cephalometric radiograph |
| Computer guided surgery | Experimental | Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.
Computer-aided planning for study group:
All planning will be done using specialized software (Anatomage Invivo 5.3) for preoperative surgical simulation and immediate postoperative evaluation.
Pre-operative Fabrication of computer aided surgical splint:
In the study group a stereo splint will be fabricated using rapid prototyping (RP) technique to guide the osteotomy and another one will be fabricated after virtual osteotomy to guide the surgical cuts. And stent for guided holes.
So that the osteotomy will be accomplished by the aid of computer guided templates that simulates the proper bite achieved preoperatively during surgical simulation and Planning. Receives: Procedure: Computer guided surgery; Device: 3D computerized tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of movement of surgical segments in millimeter
Computer guided Super-imposition of virtual surgery over the post- operative CT Scan composite models (millimeter mm).
Conventional Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion- accuracy would be compared by difference between Intervention and control in (millimeter mm).
Measured: up to 4 months
Secondary outcomes (1)
Anterior open Bite Closure (positive overbite in millimeter)
Standardized pre-surgery movement in amount of anterior open bite closure (mm) will be determined clinically and by radiograph.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start20 Feb 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApertognathiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- SM and VSM
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ammar Ribhi Abu shama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ammar Ribhi Abu shama, Cairo University
- Investigators
- Moustafa K Ezz, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277443
- Sponsor's protocol ID
- 292017
- Status last verified
- Feb 2018
- First submitted
- 6 Sep 2017
- Last updated
- 14 Feb 2018
- 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 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03277443
- Acronym / sponsor ID
- 292017
- Conditions
- Apertognathia
- Keywords
- Skeletal open bite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Ammar Ribhi Abu shamaUniversity, hospital or other
- Study start
- 20 Feb 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 11 Sep 2017 (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 patient with skeletal open bite, Dose computer-aided surgery enhances the clinical outcomes and accuracy versus conventional model surgery
Detailed description
P Adult Patients with skeletal open bite.
I Computer guided surgery.
C Conventional articulating model surgery
O Outcome measure:
Outcome Name Measuring Device Measuring Unit (mm)
O1 Accuracy
Computer guided: Super-imposition of virtual surgery over the post- operative CT Scan composite models ( millimeter mm)
Conventional : Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion ( millimeter mm)
O2 Anterior open Bite Closure
Standardized Multi Scan CT (millimeter mm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- SM and VSM
| Arm | Type | Receives |
|---|---|---|
| Conventional Model Surgery | Active comparator | Procedure: Conventional model surgery, Device: 2D cephalometric radiographLateral Cephalogram with analysis and tracing of facial profile. Modified model surgical tecnique: 1. Obtain wax bite registration. 2. Record face-bow transfer. 3. Duplication of articulating model for surgical simulation. 4. Measure all casts and bases in standard model surgery fashion. 5. Fabricate intermediate splint \& Final splint. 6. Condylar repositional splint. |
| Computer guided surgery | Experimental | Procedure: Computer guided surgery, Device: 3D computerized tomographyPreoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan. Computer-aided planning for study group: All planning will be done using specialized software (Anatomage Invivo 5.3) for preoperative surgical simulation and immediate postoperative evaluation. Pre-operative Fabrication of computer aided surgical splint: In the study group a stereo splint will be fabricated using rapid prototyping (RP) technique to guide the osteotomy and another one will be fabricated after virtual osteotomy to guide the surgical cuts. And stent for guided holes. So that the osteotomy will be accomplished by the aid of computer guided templates that simulates the proper bite achieved preoperatively during surgical simulation and Planning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffering from skeletal open bite caused by vertical posterior maxillary excess and/or short mandible ramus.
- Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
- Required two jaws orthographic surgery
Key exclusion criteria (4 listed)
- Patients with any systemic disease that may affect normal healing
- Intra-bony lesions or infections that may retard the osteotomy healing.
- Patient with bad oral hygiene.
- Uncontrolled Diabetes mellitus.
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 |
|---|---|---|
| Computer guided surgeryPreoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.Craniofacial images from 3D computerized tomography (3D-CT scan) can be used to create a 3D model, which can in turn be used for 3D Cephalometry measurements and surgical simulation.The process of 3D-model contains mounting of 3D virtual models in a 3D virtual articulator; and repositioning of 3D virtual models according to the STO then Fabrication of a 3D virtual intermediate surgical wafer; and materialization of the surgical wafer using a stereolithographic technique. The 3D model can produce actual movement of surgical cuts and movement of segments accordingly | Procedure or surgery | Computer guided surgery |
| Conventional model surgerypreparation for orthognathic surgery which involves diagnosis with 2D cephalometric radiograph, face-bow transfer and model surgery on plaster dental cast, and fabrication of intermediate and final occlusal splint. | Procedure or surgery | Conventional Model Surgery |
| 2D cephalometric radiograph2D cephalometric radiograph | Device | Conventional Model Surgery |
| 3D computerized tomography3D computerized tomography | Device | Computer guided surgery |
Primary outcome
Accuracy of movement of surgical segments in millimeter
Time frame: up to 4 months
Computer guided Super-imposition of virtual surgery over the post- operative CT Scan composite models (millimeter mm). Conventional Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion- accuracy would be compared by difference between Intervention and control in (millimeter mm).
1 secondary outcome
Anterior open Bite Closure (positive overbite in millimeter)
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- 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.
Moustafa K Ezz, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided surgery, Conventional model surgery and 2D cephalometric radiograph in people with Apertognathia, run by Ammar Ribhi Abu shama.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Feb 2018. 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 Ammar R Abu Shama, PHD (00201142354052, Dr.ammar.shama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of movement of surgical segments in millimeter (time frame: up to 4 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 14 Feb 2018.