Anterior Mandibular FractureNCT07263633
Additive Versus Subtractive Manufacturing Techniques of Custom-Made Plates for the Fixation of Interforaminal Mandibular Fractures
A study testing additive plating group and subtractive plating group in people with Anterior Mandibular Fracture, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the mechanical properties, including tensile strength, shear strength, and flexural strength, as well as the clinical outcomes of additive and subtractive manufacturing techniques used to fabricate custom-made plates for the fixation of interforaminal mandibular fractures. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Anterior Mandibular Fracture
- What is being tested?
- additive plating group and subtractive plating group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Dec 2024to 29 Oct 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Isolated or non-isolated mandibular fractures located between the mental foramina (interforaminal fractures).
Who cannot join
- Patients with relevant systemic diseases that affect bone healing.
- Comminuted fractures in which it is difficult to fix.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31527
About this study
Official title: Additive Versus Subtractive Manufacturing Techniques of Custom-Made Plates for the Fixation of Interforaminal Mandibular Fractures:A Randomized Controlled Trial
This study aims to compare the mechanical properties, including tensile strength, shear strength, and flexural strength, as well as the clinical outcomes of additive and subtractive manufacturing techniques used to fabricate custom-made plates for the fixation of interforaminal mandibular fractures. A total of 16 patients were included and allocated into two groups: one treated using plates fabricated with the additive manufacturing technique and the other with the subtractive manufacturing technique. Mechanical performance was evaluated using standardized biomechanical testing, while clinical outcomes were assessed during scheduled postoperative follow-up visits. The objective of the study is to determine which fixation approach provides superior biomechanical performance and favorable clinical healing outcomes.
Read the detailed description
This randomized clinical study included 18 patients who were assessed for eligibility. Two patients were excluded-one did not meet the inclusion criteria and another declined participation-leaving a final sample of 16 patients who were randomly allocated into two equal groups (n=8 per group). All included patients were followed throughout the entire study period, and none were lost to follow-up.
Both study groups demonstrated comparable baseline characteristics with no statistically significant differences regarding age, sex distribution, trauma side, cause of injury, type of fracture, and operative time. All surgical procedures were performed using standardized operative protocols, and postoperative evaluations were conducted at fixed intervals.
Clinical outcomes included wound healing status, postoperative edema, infection, and wound dehiscence. Functional performance was evaluated through maximum mouth opening measurements and patient-reported outcomes involving occlusion and self-chewing ability. Radiographic and mechanical assessments were also performed, including tensile strength, shear strength, and flexural bending tests for the fixation systems used in each group.
Across the follow-up period, both groups showed satisfactory wound healing, absence of infection or dehiscence, progressive improvement in mouth opening, and gradual restoration of occlusal stability and chewing function, with no significant intergroup differences in clinical parameters. Mechanical testing demonstrated significant differences between the two fixation systems.
All collected data were statistically analyzed, and outcomes were reported in accordance with CONSORT guidelines.
- Conditions
- Anterior Mandibular Fracture
- Being tested
- additive plating group, subtractive plating group
- Keywords
- Additive, Subtractive, Custom-Made Plates, Interforaminal, Mandibular, Fractures
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additive plating groupDevice
Additive manufacturing is the process of creating parts by joining materials based on 3D model data, typically layer by layer, in contrast to subtractive and formative manufacturing methods. While most of the global activity in additive manufacturing currently involves polymer-based systems, there has been increasing interest and activity in fabricating metallic parts
subtractive plating groupDevice
In CNC machining, cutting tool removes material to achieve the desired geometry. The process involves using CAD to create the model to be machined and CAM to provide instructions to the CNC machine on how to remove the material. There are three major machining processes for material removal based on 3D models: turning, drilling, and milling. Additional subtractive manufacturing techniques, such as laser cutting, waterjet cutting, electrical discharge machining, and plasma cutting, are typically used for 2D machining
| Study group | Role | What they receive |
|---|---|---|
| additive plating group | Experimental | Additive manufacturing typically describes any process where material is gradually added, layer by layer, to form a final product. The term is often used interchangeably with 3D printing and rapid prototyping, although rapid prototyping can also involve other techniques beyond additive methods Receives: Device: additive plating group |
| subtractive plating group | Active comparator | In subtractive manufacturing, objects are created by progressively removing material from a solid block or sheet through processes such as cutting, drilling, boring, or grinding. While these processes can be performed manually, they are more commonly executed using computer numeric control (CNC). CNC machining is the most widely used subtractive manufacturing process today Receives: Device: subtractive plating group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tensile Strength
Tensile strength will be measured using a universal testing machine (Instron) to evaluate the resistance of each plate to tensile forces according to standardized biomechanical testing protocols.
Unit of Measure:
Newton (N)
Measurement Tool:
Instron Universal Testing Machine.
Measured: After fabrication of the plates (baseline biomechanical assessment)
Shear Strength
Shear strength will be tested using the Instron universal testing machine to determine the resistance of the plate to shear loading.
Time Frame:
After fabrication of the plates (baseline biomechanical assessment)
Unit of Measure:
Newton (N)
Measurement Tool:
Instron Universal Testing Machine.
Measured: Immediately after fixation (within 24 hours)
Outcome Measure
Title: Overall Mechanical Stability Description: Overall biomechanical stability will be evaluated based on combined tensile, shear results.
Time Frame: Within 24 hours after surgical fixation Unit of Measure: Stability index (unitless)
Measured: Immediately after fixation (within 24 hours)
Secondary outcomes (4)
Mouth Opening Measurement
Maximum inter-incisal distance will be measured using a digital caliper to assess functional recovery and detect any restrictions.
Unit of Measure:
Millimeters (mm)
Measurement Tool:
Digital caliper
Measured: 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Wound Healing Score
Wound healing will be assessed using the Landry, Turnbull, and Howley Wound Healing Index, which evaluates tissue color, bleeding on palpation, granulation tissue, and overall appearance.
Unit of Measure:
Score (0-5 scale)
Measurement Tool:
Landry, Turnbull \& Howley Index (clinical scale)
Measured: 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Postoperative Edema Measurement
Edema will be measured using standardized linear facial measurements (tragus-pogonion and gonion-pogonion distances) to quantify postoperative swelling.
Unit of Measure:
Millimeters (mm)
Measurement Tool:
Facial linear measurement with ruler/caliper.
Measured: 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Postoperative Infection Assessment
Infection will be evaluated using the CDC Surgical Site Infection (SSI) criteria, including redness, swelling, warmth, purulent discharge, fever >38°C, and localized tenderness at the surgical site.Unit of Measure:
Presence or absence (Yes/No)
Measurement Tool:
CDC SSI Diagnostic Criteria (clinical assessment)
Measured: 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start28 Dec 2024
- Primary completion30 Jul 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Mandibular FractureStudies of the same condition, open and under way.
- More trials run by Tanta 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FARIS INAD S ALANAZI, Tanta University
- Investigators
- FARIS I ALANAZI, Principal investigator, Faculty of Dentistry, Tanta UniversityRafic R Bedir, Principal investigator, Faculty of Dentistry, Tanta UniversityAhmed G Abushahba, Principal investigator, Faculty of Dentistry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263633
- Sponsor's protocol ID
- TANTAOMSF-IFMF-149
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 4 Dec 2025
- 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Versus Subtractive Manufacturing Techniques of Custom-Made Plates for the Fixation of Interforaminal Mandibular Fractures:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07263633
- Acronym / sponsor ID
- TANTAOMSF-IFMF-149
- Conditions
- Anterior Mandibular Fracture
- Keywords
- Additive, Subtractive, Custom-Made Plates, Interforaminal, Mandibular, Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 4 Dec 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.
This study aims to compare the mechanical properties, including tensile strength, shear strength, and flexural strength, as well as the clinical outcomes of additive and subtractive manufacturing techniques used to fabricate custom-made plates for the fixation of interforaminal mandibular fractures. A total of 16 patients were included and allocated into two groups: one treated using plates fabricated with the additive manufacturing technique and the other with the subtractive manufacturing technique. Mechanical performance was evaluated using standardized biomechanical testing, while clinical outcomes were assessed during scheduled postoperative follow-up visits. The objective of the study is to determine which fixation approach provides superior biomechanical performance and favorable clinical healing outcomes.
Detailed description
This randomized clinical study included 18 patients who were assessed for eligibility. Two patients were excluded-one did not meet the inclusion criteria and another declined participation-leaving a final sample of 16 patients who were randomly allocated into two equal groups (n=8 per group). All included patients were followed throughout the entire study period, and none were lost to follow-up.
Both study groups demonstrated comparable baseline characteristics with no statistically significant differences regarding age, sex distribution, trauma side, cause of injury, type of fracture, and operative time. All surgical procedures were performed using standardized operative protocols, and postoperative evaluations were conducted at fixed intervals.
Clinical outcomes included wound healing status, postoperative edema, infection, and wound dehiscence. Functional performance was evaluated through maximum mouth opening measurements and patient-reported outcomes involving occlusion and self-chewing ability. Radiographic and mechanical assessments were also performed, including tensile strength, shear strength, and flexural bending tests for the fixation systems used in each group.
Across the follow-up period, both groups showed satisfactory wound healing, absence of infection or dehiscence, progressive improvement in mouth opening, and gradual restoration of occlusal stability and chewing function, with no significant intergroup differences in clinical parameters. Mechanical testing demonstrated significant differences between the two fixation systems.
All collected data were statistically analyzed, and outcomes were reported in accordance with CONSORT guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| additive plating group | Experimental | Device: additive plating groupAdditive manufacturing typically describes any process where material is gradually added, layer by layer, to form a final product. The term is often used interchangeably with 3D printing and rapid prototyping, although rapid prototyping can also involve other techniques beyond additive methods |
| subtractive plating group | Active comparator | Device: subtractive plating groupIn subtractive manufacturing, objects are created by progressively removing material from a solid block or sheet through processes such as cutting, drilling, boring, or grinding. While these processes can be performed manually, they are more commonly executed using computer numeric control (CNC). CNC machining is the most widely used subtractive manufacturing process today |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Isolated or non-isolated mandibular fractures located between the mental foramina (interforaminal fractures).
Key exclusion criteria (2 listed)
- Patients with relevant systemic diseases that affect bone healing.
- Comminuted fractures in which it is difficult to fix.
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 |
|---|---|---|
| additive plating groupAdditive manufacturing is the process of creating parts by joining materials based on 3D model data, typically layer by layer, in contrast to subtractive and formative manufacturing methods. While most of the global activity in additive manufacturing currently involves polymer-based systems, there has been increasing interest and activity in fabricating metallic parts | Device | additive plating group |
| subtractive plating groupIn CNC machining, cutting tool removes material to achieve the desired geometry. The process involves using CAD to create the model to be machined and CAM to provide instructions to the CNC machine on how to remove the material. There are three major machining processes for material removal based on 3D models: turning, drilling, and milling. Additional subtractive manufacturing techniques, such as laser cutting, waterjet cutting, electrical discharge machining, and plasma cutting, are typically used for 2D machining | Device | subtractive plating group |
Primary outcome
Tensile Strength
Time frame: After fabrication of the plates (baseline biomechanical assessment)
Tensile strength will be measured using a universal testing machine (Instron) to evaluate the resistance of each plate to tensile forces according to standardized biomechanical testing protocols. Unit of Measure: Newton (N) Measurement Tool: Instron Universal Testing Machine.
Shear Strength
Time frame: Immediately after fixation (within 24 hours)
Shear strength will be tested using the Instron universal testing machine to determine the resistance of the plate to shear loading. Time Frame: After fabrication of the plates (baseline biomechanical assessment) Unit of Measure: Newton (N) Measurement Tool: Instron Universal Testing Machine.
Outcome Measure
Time frame: Immediately after fixation (within 24 hours)
Title: Overall Mechanical Stability Description: Overall biomechanical stability will be evaluated based on combined tensile, shear results. Time Frame: Within 24 hours after surgical fixation Unit of Measure: Stability index (unitless)
4 secondary outcomes
Mouth Opening Measurement
Time frame: 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Wound Healing Score
Time frame: 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Postoperative Edema Measurement
Time frame: 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Postoperative Infection Assessment
Time frame: 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
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 4 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Anterior Mandibular Fracture
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Evaluation of Condylar Position After Anterior Mandibular Fracture Fixation Using Plates Versus Headless Compression Screws
Anterior Mandibular Fracture
Not yet recruiting
Comparing Bone Healing in Jaw Fractures Fixed With Herbert Screws Versus 3D Miniplates
Anterior Mandibular Fracture
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.
FARIS I ALANAZI principal investigator
Faculty of Dentistry, Tanta University
Rafic R Bedir principal investigator
Faculty of Dentistry, Tanta University
Ahmed G Abushahba principal investigator
Faculty of Dentistry, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additive plating group and subtractive plating group in people with Anterior Mandibular Fracture, run by Tanta 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 1 inclusion and 2 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 4 Dec 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?
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?
Tensile Strength (time frame: After fabrication of the plates (baseline biomechanical assessment)). The study lists 3 primary outcomes in all. 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 4 Dec 2025.