Evaluation of the Accuracy of Transferring the Virtual Planning to the SurgeryNCT04421144
Accuracy of CAD/CAM Cutting Guides and Customized Titanium Plates for Virtual Planning Transfer in Bimaxillary Orthognathic Surgeries
A study testing orthognathic surgery in people with Evaluation of the Accuracy of Transferring the Virtual Planning to the Surgery, run by Cairo University.
Trial summary
In this research, we aim to use CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of the Accuracy of Transferring the Virtual Planning to the Surgery
- What is being tested?
- orthognathic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Nov 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Who cannot join
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
About this study
In this research, we aim to use CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.
Read the detailed description
Intervention:
- Diagnostic procedure: 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 will be taken for acquiring diagnostic dental casts. A heat-cured acrylic resin stent will be constructed on the stone model. Using the stent, a radiographic stent will be constructed for imaging and planning procedures. Cone Beam Computed Topography (CBCT) for the patients will be carried out. All patients will be referred to an orthodontist for presurgical phase of orthodontic treatment for decompensation and to attain stable occlusion in three points in the surgery.
- Planning procedure: All planning procedures are carried out by MZ and under the supervision of AH and MH. Computer-aided planning \& MCROS design for all patients: All planning will be done using specialized software . One virtual 3D anatomic model of the patient will be constructed through thresholding \& image fusion. Virtual Le Fort I osteotomy and then the maxilla will be virtually adjusted according to the facial symmetry planes and clinical anthropometric analysis. Virtual simulation of the sagittal split of the mandible will be performed and the mandible position adjusted according to the bite registered. After settling on the optimum virtual plan, designing of the cutting guides and titanium plates will then be started.
- Intra-operative procedures: The surgical procedures will be carried out by MZ 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 anaesthesia (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 be carried out. Dissection and reflection to reach the bone will be carried out. Le Fort I Maxillary \& Bilateral Sagittal split mandibular osteotomies will be carried out using the osteotomy cutting guides. Complete mobilization of maxillary and mandibular segments. Reposition and fixation of the maxillary \& mandibular segments using customized titanium plates. The incisions will be closed with continuous mattress resorbable sutures .
- Post-operative care: 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.
- Criteria for discontinuing or modifying intervention:
- Difficulty with the use of cutting guides and customized titanium plates.
- Inaccurate translation of the surgical plan.
- Strategies to improve adherence to intervention: Postoperative orthodontic treatment is necessary after the operation to obtain the final stable occlusion.
- Concomitant care: Not needed.
- Follow up \& Evaluation:
Post-operative treatment will start immediately postoperative (4 hours). The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.
Within the first week 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 4-6 weeks postoperatively.
The technique will be evaluated by applying hard tissue parameters to compare the virtual orthognathic planning (P0) with the postoperative result (P1) using 3D cephalometry and image fusion.
- Being tested
- orthognathic surgery
- Keywords
- CAD/CAM, orthognathic surgery, virtual planning, cutting guides, customized titanium plates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthognathic surgeryProcedure or surgery
patients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | using CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches. Receives: Procedure: orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the surgical transfer
Computer software on pre/postoperative CBCT
Measured: within first week postoperatively
Secondary outcomes (1)
Patient satisfaction: Visual analog scale (questionnaire)
Visual analog scale (questionnaire)
Measured: one week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of the Accuracy of Transferring the Virtual Planning to the SurgeryStudies 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
- Model description
- case series
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Zain, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421144
- Sponsor's protocol ID
- Dr.Zain protocol
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of CAD/CAM Cutting Guides and Customized Titanium Plates for Virtual Planning Transfer in Bimaxillary Orthognathic Surgeries
- ClinicalTrials.gov ID
- NCT04421144
- Acronym / sponsor ID
- Dr.Zain protocol
- Keywords
- CAD/CAM, orthognathic surgery, virtual planning, cutting guides, customized titanium plates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 9 Jun 2020 (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 this research, we aim to use CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.
Detailed description
Intervention:
- Diagnostic procedure: 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 will be taken for acquiring diagnostic dental casts. A heat-cured acrylic resin stent will be constructed on the stone model. Using the stent, a radiographic stent will be constructed for imaging and planning procedures. Cone Beam Computed Topography (CBCT) for the patients will be carried out. All patients will be referred to an orthodontist for presurgical phase of orthodontic treatment for decompensation and to attain stable occlusion in three points in the surgery.
- Planning procedure: All planning procedures are carried out by MZ and under the supervision of AH and MH. Computer-aided planning \& MCROS design for all patients: All planning will be done using specialized software . One virtual 3D anatomic model of the patient will be constructed through thresholding \& image fusion. Virtual Le Fort I osteotomy and then the maxilla will be virtually adjusted according to the facial symmetry planes and clinical anthropometric analysis. Virtual simulation of the sagittal split of the mandible will be performed and the mandible position adjusted according to the bite registered. After settling on the optimum virtual plan, designing of the cutting guides and titanium plates will then be started.
- Intra-operative procedures: The surgical procedures will be carried out by MZ 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 anaesthesia (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 be carried out. Dissection and reflection to reach the bone will be carried out. Le Fort I Maxillary \& Bilateral Sagittal split mandibular osteotomies will be carried out using the osteotomy cutting guides. Complete mobilization of maxillary and mandibular segments. Reposition and fixation of the maxillary \& mandibular segments using customized titanium plates. The incisions will be closed with continuous mattress resorbable sutures .
- Post-operative care: 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.
- Criteria for discontinuing or modifying intervention:
- Difficulty with the use of cutting guides and customized titanium plates.
- Inaccurate translation of the surgical plan.
- Strategies to improve adherence to intervention: Postoperative orthodontic treatment is necessary after the operation to obtain the final stable occlusion.
- Concomitant care: Not needed.
- Follow up \& Evaluation:
Post-operative treatment will start immediately postoperative (4 hours). The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.
Within the first week 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 4-6 weeks postoperatively.
The technique will be evaluated by applying hard tissue parameters to compare the virtual orthognathic planning (P0) with the postoperative result (P1) using 3D cephalometry and image fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case series
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: orthognathic surgeryusing CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Key exclusion criteria (3 listed)
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
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 |
|---|---|---|
| orthognathic surgerypatients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates. | Procedure or surgery | study group |
Primary outcome
Accuracy of the surgical transfer
Time frame: within first week postoperatively
Computer software on pre/postoperative CBCT
1 secondary outcome
Patient satisfaction: Visual analog scale (questionnaire)
Time frame: one week postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing orthognathic surgery in people with Evaluation of the Accuracy of Transferring the Virtual Planning to the Surgery, 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 3 inclusion and 3 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 9 Jun 2020. 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?
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?
Accuracy of the surgical transfer (time frame: within first week postoperatively). 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 9 Jun 2020.