Mandibular FracturesNCT06392204
CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique
A study testing CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate and Champy's techqniue in people with Mandibular Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate and Champy's techqniue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2023to 18 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral mandibular angle fracture with or without associated mandibular fractures in need of open reduction and internal fixation.
- Patients above 18 years old
- Sufficient dentition to reproduce the occlusal relationships
- Patient's consent to participate
Who cannot join
- Patients with comminuted mandibular angle fracture(s)
- Patients with any systemic disease that may affect normal healing
- Patients undergoing chemotherapy or radiotherapy related to the head and neck region
- Intra-bony lesions in the fracture area that may interfere with proper anatomical reduction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)
This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.
Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.
Read more
Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.
Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.
Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.
Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.
Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.
- Conditions
- Mandibular Fractures
- Being tested
- CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate, Champy's techqniue
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plateProcedure or surgery
Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate
Champy's techqniueProcedure or surgery
Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate
| Study group | Role | What they receive |
|---|---|---|
| Custom made reduction guides and 3D grid plates | Experimental | Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate Receives: Procedure: CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate |
| Stock titanium plates | Active comparator | Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate Receives: Procedure: Champy's techqniue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.
Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software
Measured: Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)
Secondary outcomes (1)
Postoperative occlusion
Assessment of postoperative occlusion clinically using a millimeter caliper, occlusion will be categorized into; satisfactory (no gap), mild derangement (gap of 1-2 mm) and deranged (gap more than 2 mm)
Measured: Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start7 Oct 2023
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Louay Ali Hosni, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392204
- Sponsor's protocol ID
- PSIs
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hosni A, Shawky M, Sakr MI, El-Beialy W, Ezz M, Atef M. Assessment of accuracy and efficiency of guided fixation of customized 3D miniplates vs Champy's technique in stabilization of mandibular angle fractures: A randomized controlled trial. Clin Oral Investig. 2026 Oct 2;30(10):496. doi: 10.1007/s00784-026-07118-w.
PubMed 42825839
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT06392204
- Acronym / sponsor ID
- PSIs
- Conditions
- Mandibular Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 30 Apr 2024 (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.
This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.
Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.
Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.
Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.
Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.
Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.
Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom made reduction guides and 3D grid plates | Experimental | Procedure: CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plateMandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate |
| Stock titanium plates | Active comparator | Procedure: Champy's techqniueMandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with unilateral mandibular angle fracture with or without associated mandibular fractures in need of open reduction and internal fixation.
- Patients above 18 years old
- Sufficient dentition to reproduce the occlusal relationships
- Patient's consent to participate
Key exclusion criteria (4 listed)
- Patients with comminuted mandibular angle fracture(s)
- Patients with any systemic disease that may affect normal healing
- Patients undergoing chemotherapy or radiotherapy related to the head and neck region
- Intra-bony lesions in the fracture area that may interfere with proper anatomical reduction.
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 |
|---|---|---|
| CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plateMandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate | Procedure or surgery | Custom made reduction guides and 3D grid plates |
| Champy's techqniueMandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate | Procedure or surgery | Stock titanium plates |
Primary outcome
Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.
Time frame: Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)
Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software
1 secondary outcome
Postoperative occlusion
Time frame: Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3)
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 9 Apr 2026.
- Derived from this study: PubMed 42825839Hosni A, Shawky M, Sakr MI, El-Beialy W, Ezz M, Atef M. Assessment of accuracy and efficiency of guided fixation of customized 3D miniplates vs Champy's technique in stabilization of mandibular angle fractures: A randomized controlled trial. Clin Oral Investig. 2026 Oct 2;30(10):496. doi: 10.1007/s00784-026-07118-w.
Related trials for Mandibular Fractures
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Not yet recruiting
Clinical And Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures
Mandibular Angle Fractures, Mandibular Body Fractures
Recruiting
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
Pediatric Mandibular Fracture
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate and Champy's techqniue in people with Mandibular Fractures, run by Cairo 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 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 9 Apr 2026. 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?
Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan. (time frame: Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)). 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 NCT06392204, 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 9 Apr 2026.