Mandibular FracturesNCT06883331
Validity of Computed Guided Technology in Proper Placement of Intermaxillary Fixation Screws in Mandibular Fractures
A study testing intermaxillary fixation using IMF screws and intermaxillary fixation using IMF screws with surgical guide in people with Mandibular Fractures, run by Suez Canal University at 1 site in Egypt.
Trial summary
A randomized clinical study that aims to assess the validity of the use of computer guided technique in the proper placement of IMF screws in mandibular fractures Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- intermaxillary fixation using IMF screws and intermaxillary fixation using IMF screws with surgical guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Apr 2024to Apr 2025
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suffer from recent mandibular fractures that requires fixation
- Dentulous patients
- Medically fit for surgery (ASA I AND ASA II)
Who cannot join
- Edentulous patients
- Patient with bone pathosis
- patients with primary and mixed dentition
- pathologic mandibular fracture
Trial locations and contacts
1 site in 1 country.
About this study
A randomized clinical study that aims to assess the validity of the use of computer guided technique in the proper placement of IMF screws in mandibular fractures
Read the detailed description
Fractures of the facial skeleton involving the teeth bearing segments can lead to disruption of the dental occlusion, and difficulties with speech and mastication. The temporary fixation of opposing jaws is called maxillomandibular fixation and is usually secured through placement of IMF screws and wires. The correct placement of IMF screws can be challenging. Such planning may make use of radiographs and computed tomography scans. Knowledge of safe zones in the facial skeleton for screw placement through the use of pre-operative 3-dimensional planning may prevent some of the cited complications. The use of a custom made surgical guide for IMF screw placement has the potential to reduce operation time, optimize screw position, and minimize injury to dental roots and important anatomical structures. Aim: The aim of this study is to Assess the use of computed guided technique in the proper placement of IMF screws in mandibular fractures. Materials and Methods: This clinical study will be conducted on 20 patients who will be equally and randomly distributed into 2 groups: Group A: 10 patients will be treated with 3D guided placement of IMF screw. Group B: 10 patients will be treated with Conventional placement of IMF screws.
To assess the accuracy of IMF screws placement in each group.
- Conditions
- Mandibular Fractures
- Being tested
- intermaxillary fixation using IMF screws, intermaxillary fixation using IMF screws with surgical guide
- Keywords
- mandible, fracture, fixation, screws
- Medical subject headings
- Mandibular Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermaxillary fixation using IMF screwsProcedure or surgery
Also called IMF
IMF screws will be placed at the junction of the attached and alveolar mucosa, after verifying the root position on the orthopantomogram (OPG) radiograph. One screw in each quadrant was sufficient; all IMF screws will be placed with the patient under local anesthesia or general anesthesia . Cortical perforation with a 1.5-mm drill bit under copious irrigation will be performed or by self-drilling IMF screws and the IMF screws will be tightened on the drilled hole.
After IMFS placement, intraoperative IMF will be achieved by passing round, stainless steel wires through the screw head to achieve satisfactory occlusion.
intermaxillary fixation using IMF screws with surgical guideProcedure or surgery
The patient's CBCT images in DICOM format will be converted into stereolithographic (STL) images using the segmentation software.
The converted CBCT STL images will be integrated to obtain the exact tooth morphology Virtual surgical planning (VSP) will be carried out using software to select the exact position of IMF screws placement away from any vital, anatomical or tooth structure.
these locations will be incorporated into the patients specific IMF surgical guides as access holes to direct the IMF screws drill.
Guide will be constructed with a thickness of 2-3 mm and printed using Photopolymer Resin® (Form labs) in the CAD/CAM 3- dimensional (3D) printer
| Study group | Role | What they receive |
|---|---|---|
| IMF screws without surgical guide | Active comparator | control group: the patients will be treated without surgical guide, conventionally based on surgeon's clinical Experience. Receives: Procedure: intermaxillary fixation using IMF screws |
| IMF screws with a surgical guide | Experimental | study group: the patients will be treated using Computer Assisted Surgical Guide to achieve accurate placement of IMF screws. |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic evaluation
radiographic follow up of the patients immediate postoperatively with CBCT to assess the accuracy of IMF screws placement.
CBCT will be assessed to detect any injury to the roots of the teeth adjacent to the IMF screws as well as any injury to the adjacent vital structures
Measured: immediately postoperative
Secondary outcomes (1)
clinical evaluation
clinical evaluation will be done intra-operatively to assess the time consumed in the study group compared to the control group
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start27 Apr 2024
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed A Elsholkamy, Professor, Study director, Suez Canal UniversityYasser N Helmy, Prof, Study director, Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academymohamed H Elsherbiny, Dr, Principal investigator, Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883331
- Sponsor's protocol ID
- 763/2024
- Other IDs
- Suez Canal University
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joseph Kamal. 2021. Computer Assisted Guided Placement of IMF Screws in Craniomaxillofacial Trauma: An Evolving Technique, Vol. 2(2) 170-173 DOI: 10.1177/27325016211008654 journals.sagepub.com/home/fac
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Computed Guided Technology in Proper Placement of Intermaxillary Fixation Screws in Mandibular Fractures
- ClinicalTrials.gov ID
- NCT06883331
- Acronym / sponsor ID
- 763/2024
- Conditions
- Mandibular Fractures
- Keywords
- mandible, fracture, fixation, screws
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Mar 2025 (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.
A randomized clinical study that aims to assess the validity of the use of computer guided technique in the proper placement of IMF screws in mandibular fractures
Detailed description
Fractures of the facial skeleton involving the teeth bearing segments can lead to disruption of the dental occlusion, and difficulties with speech and mastication. The temporary fixation of opposing jaws is called maxillomandibular fixation and is usually secured through placement of IMF screws and wires. The correct placement of IMF screws can be challenging. Such planning may make use of radiographs and computed tomography scans. Knowledge of safe zones in the facial skeleton for screw placement through the use of pre-operative 3-dimensional planning may prevent some of the cited complications. The use of a custom made surgical guide for IMF screw placement has the potential to reduce operation time, optimize screw position, and minimize injury to dental roots and important anatomical structures. Aim: The aim of this study is to Assess the use of computed guided technique in the proper placement of IMF screws in mandibular fractures. Materials and Methods: This clinical study will be conducted on 20 patients who will be equally and randomly distributed into 2 groups: Group A: 10 patients will be treated with 3D guided placement of IMF screw. Group B: 10 patients will be treated with Conventional placement of IMF screws.
To assess the accuracy of IMF screws placement in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMF screws without surgical guide | Active comparator | Procedure: intermaxillary fixation using IMF screwscontrol group: the patients will be treated without surgical guide, conventionally based on surgeon's clinical Experience. |
| IMF screws with a surgical guide | Experimental | –study group: the patients will be treated using Computer Assisted Surgical Guide to achieve accurate placement of IMF screws. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffer from recent mandibular fractures that requires fixation
- Dentulous patients
- Medically fit for surgery (ASA I AND ASA II)
Key exclusion criteria (4 listed)
- Edentulous patients
- Patient with bone pathosis
- patients with primary and mixed dentition
- pathologic mandibular fracture
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 |
|---|---|---|
| intermaxillary fixation using IMF screwsAlso: IMFIMF screws will be placed at the junction of the attached and alveolar mucosa, after verifying the root position on the orthopantomogram (OPG) radiograph. One screw in each quadrant was sufficient; all IMF screws will be placed with the patient under local anesthesia or general anesthesia . Cortical perforation with a 1.5-mm drill bit under copious irrigation will be performed or by self-drilling IMF screws and the IMF screws will be tightened on the drilled hole. After IMFS placement, intraoperative IMF will be achieved by passing round, stainless steel wires through the screw head to achieve satisfactory occlusion. | Procedure or surgery | IMF screws without surgical guide |
| intermaxillary fixation using IMF screws with surgical guideThe patient's CBCT images in DICOM format will be converted into stereolithographic (STL) images using the segmentation software. The converted CBCT STL images will be integrated to obtain the exact tooth morphology Virtual surgical planning (VSP) will be carried out using software to select the exact position of IMF screws placement away from any vital, anatomical or tooth structure. these locations will be incorporated into the patients specific IMF surgical guides as access holes to direct the IMF screws drill. Guide will be constructed with a thickness of 2-3 mm and printed using Photopolymer Resin® (Form labs) in the CAD/CAM 3- dimensional (3D) printer | Procedure or surgery | – |
Primary outcome
radiographic evaluation
Time frame: immediately postoperative
radiographic follow up of the patients immediate postoperatively with CBCT to assess the accuracy of IMF screws placement. CBCT will be assessed to detect any injury to the roots of the teeth adjacent to the IMF screws as well as any injury to the adjacent vital structures
1 secondary outcome
clinical evaluation
Time frame: intra-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- BackgroundJoseph Kamal. 2021. Computer Assisted Guided Placement of IMF Screws in Craniomaxillofacial Trauma: An Evolving Technique, Vol. 2(2) 170-173 DOI: 10.1177/27325016211008654 journals.sagepub.com/home/fac
- Individual participant dataSharing planned: No
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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.
Mohamed A Elsholkamy, Professor study director
Suez Canal University
Yasser N Helmy, Prof study director
Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy
mohamed H Elsherbiny, Dr principal investigator
Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermaxillary fixation using IMF screws and intermaxillary fixation using IMF screws with surgical guide in people with Mandibular Fractures, run by Suez Canal University 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 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 19 Mar 2025. 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?
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?
radiographic evaluation (time frame: immediately postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06883331, which also lists 1 linked publication.
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 19 Mar 2025.