Mandibular FracturesCOMET-OMFNCT07206134
Evaluation of Modified Omega Plate in the Management of Mandibular Fractures Compared With Conventional Fixation
A study testing Modified Omega bone plate for fixation of mandibular fractures in mental foramen region and Conventional miniplates for fixation of mandibular fractures in people with Mandibular Fractures and Fracture in Mental Nerve Region, run by Tanta University at 1 site in Egypt.
Trial summary
Twelve adult patients with mandibular fractures in the mental region were enrolled and randomly divided into two equal groups. Group I received fixation using custom-designed modified omega bone plates, while Group II was treated with conventional titanium miniplates following Champy's technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Fractures, Fracture in Mental Nerve Region
- What is being tested?
- Modified Omega bone plate for fixation of mandibular fractures in mental foramen region and Conventional miniplates for fixation of mandibular fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 4 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with displaced mandibular parasymphysis or body fracture in the mental nerve region
- Indicated for open reduction and internal fixation (ORIF)
Who cannot join
- Patients with systemic diseases that affect bone healing
- Fractures with crushed mental foramen
- Comminuted fractures where fixation is difficult
- Patients with anatomical variations (e.g., bifid inferior alveolar or mental nerve), based on preoperative CT nerve tracing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Omega Bone Plate Versus Conventional Miniplates for Fixation of Mandibular Fractures in Mental Nerve Region
Twelve adult patients with mandibular fractures in the mental region were enrolled and randomly divided into two equal groups. Group I received fixation using custom-designed modified omega bone plates, while Group II was treated with conventional titanium miniplates following Champy's technique. Virtual surgical planning and 3D printing technology were used to fabricate customized plates in Group I. Clinical and radiographic assessments were conducted immediately, at 1 week, 3 months, and 6 months postoperatively. Parameters evaluated included soft tissue healing, pain, facial edema, lower lip paresthesia, maximal mouth opening, occlusion, fracture stability, and hardware integrity.
Read the detailed description
This study was conducted on twelve adult patients with mandibular fracture in mental nerve region, selected from the outpatient clinic, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.
The selected patients were randomly divided into two equal groups, group I (6 patients) were treated by modified omega bone plate, while group II (6 patients) were treated by 2.0 mm conventional miniplates according to Champy's principle. A comparison between the two groups was conducted.
Modified Omega bone plate is a specially-designed, 8-hole, titanium miniplate modified by adding upper struts to the Ω symbol. It has lower horizontal struts (which provides stability along the lower border) with four holes, the proximal 2 holes are round and the distal are pear shape (compression holes). Two vertical struts at the ends of the horizontal struts (which provide resistance against the torsional forces),Upper horizontal struts (which counteract the tensional forces along the alveolar border) with four holes the proximal 2 holes are round and the distal are pear shape. The omega shape of this plate helps it to adapt easily around the mental neurovascular bundle.
Preoperative evaluation of the patients was carried out by taking history and performing clinical and radiographic examinations. Clinical examination included intraoral and extraoral inspection and palpation of the fracture sites. Radiographic examination was used to determine the site, number, type of fractures and degree of displacement.
Under general anesthesia, the fracture line was exposed through an intraoral approach, and the fracture segments were reduced. In group I, fixation of the reduced segments was done with modified omega bone plate which predetermined virtually. In group II, 2conventional miniplates placed on inferior border \& subapical were used to fix the fracture.
Postoperative clinical evaluation were performed immediately, one week, two weeks, one month, three months and postoperative radiographic evaluation were performed immediately, three months and six months. The postoperative clinical evaluation included presence or absence of infection, bony union or stability, state of occlusion, maximal mouth opening, sensory nerve function, condition of teeth related to the fracture line and, patient's tolerance to the plate.
- Being tested
- Modified Omega bone plate for fixation of mandibular fractures in mental foramen region, Conventional miniplates for fixation of mandibular fractures
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Omega bone plate for fixation of mandibular fractures in mental foramen regionProcedure or surgery
Reflection of vestibular flap without dissection around mental bundle and fracture reduction and fixation with 3D Modified Omega bone plate
Conventional miniplates for fixation of mandibular fracturesProcedure or surgery
Reflection of vestibular flap with dissection around mental bundle and fracture reduction and fixation with 2 miniplates
| Study group | Role | What they receive |
|---|---|---|
| Modified Omega bone plate used for fixation of mandibular fractures in mental foramen region | Experimental | Reflection of vestibular flap without dissection around mental bundle and fracture reduction and fixation with 3D Modified Omega bone plate Receives: Procedure: Modified Omega bone plate for fixation of mandibular fractures in mental foramen region |
| Conventional miniplates used for fixation of mandibular fractures in mental foramen region | Experimental | Reflection of vestibular flap and dissection around mental bundle and fracture reduction and fixation with 2 miniplates Receives: Procedure: Conventional miniplates for fixation of mandibular fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured using Visual Analogue Scale (VAS)
Pain will be assessed using a 10-cm Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: At 1 day, 3 days, 1 week, and 1 month postoperatively
Secondary outcomes (6)
Facial edema measured using linear facial measurements
Edema will be assessed utilizing a horizontal and vertical guide with a tape on four reference points: outer canthus of the eye, angle of the mandible, tragus of the ear and outer corner of the mouth respectively. To obtain the percentage of facial swelling, the difference between measurements of the postoperative and preoperative periods will be divided by the value of the preoperative period.
Souza JA, Consone DP. Method for measurement of facial edema after oral surgery.
Measured: At 1 day, 3 days, 1 week
Neurosensory function assessed by two point discrimination test
Sensory function tested using caliber
Measured: Up to 3 months
Maximal Interincisal Opening (MIO)
Measured using digital caliper between maxillary and mandibular central incisors.
Measured: Preoperative, and postoperative day 1, day 3, 1 week, and 1 month
Occlusion Status
Clinical evaluation of occlusion compared with pre-injury status using ulgics questionnaire
Measured: Postoperative 1 week and 1 month
Operation Time
Total duration of surgery measured from first incision to last suture.
Measured: Intraoperative
Interfragmentary Gap
Linear measurement radiographically on immediate postoperative CT
Measured: 1 day Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Mar 2023
- Primary completion1 Dec 2024
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies 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
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed sobhie abdelhameed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206134
- Sponsor's protocol ID
- TantaOMS-OMEGAvsCONV-2025
- Acronym
- COMET-OMF
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Omega Bone Plate Versus Conventional Miniplates for Fixation of Mandibular Fractures in Mental Nerve Region
- ClinicalTrials.gov ID
- NCT07206134
- Acronym / sponsor ID
- COMET-OMF / TantaOMS-OMEGAvsCONV-2025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 3 Oct 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.
Twelve adult patients with mandibular fractures in the mental region were enrolled and randomly divided into two equal groups. Group I received fixation using custom-designed modified omega bone plates, while Group II was treated with conventional titanium miniplates following Champy's technique. Virtual surgical planning and 3D printing technology were used to fabricate customized plates in Group I. Clinical and radiographic assessments were conducted immediately, at 1 week, 3 months, and 6 months postoperatively. Parameters evaluated included soft tissue healing, pain, facial edema, lower lip paresthesia, maximal mouth opening, occlusion, fracture stability, and hardware integrity.
Detailed description
This study was conducted on twelve adult patients with mandibular fracture in mental nerve region, selected from the outpatient clinic, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.
The selected patients were randomly divided into two equal groups, group I (6 patients) were treated by modified omega bone plate, while group II (6 patients) were treated by 2.0 mm conventional miniplates according to Champy's principle. A comparison between the two groups was conducted.
Modified Omega bone plate is a specially-designed, 8-hole, titanium miniplate modified by adding upper struts to the Ω symbol. It has lower horizontal struts (which provides stability along the lower border) with four holes, the proximal 2 holes are round and the distal are pear shape (compression holes). Two vertical struts at the ends of the horizontal struts (which provide resistance against the torsional forces),Upper horizontal struts (which counteract the tensional forces along the alveolar border) with four holes the proximal 2 holes are round and the distal are pear shape. The omega shape of this plate helps it to adapt easily around the mental neurovascular bundle.
Preoperative evaluation of the patients was carried out by taking history and performing clinical and radiographic examinations. Clinical examination included intraoral and extraoral inspection and palpation of the fracture sites. Radiographic examination was used to determine the site, number, type of fractures and degree of displacement.
Under general anesthesia, the fracture line was exposed through an intraoral approach, and the fracture segments were reduced. In group I, fixation of the reduced segments was done with modified omega bone plate which predetermined virtually. In group II, 2conventional miniplates placed on inferior border \& subapical were used to fix the fracture.
Postoperative clinical evaluation were performed immediately, one week, two weeks, one month, three months and postoperative radiographic evaluation were performed immediately, three months and six months. The postoperative clinical evaluation included presence or absence of infection, bony union or stability, state of occlusion, maximal mouth opening, sensory nerve function, condition of teeth related to the fracture line and, patient's tolerance to the plate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Modified Omega bone plate used for fixation of mandibular fractures in mental foramen region | Experimental | Procedure: Modified Omega bone plate for fixation of mandibular fractures in mental foramen regionReflection of vestibular flap without dissection around mental bundle and fracture reduction and fixation with 3D Modified Omega bone plate |
| Conventional miniplates used for fixation of mandibular fractures in mental foramen region | Experimental | Procedure: Conventional miniplates for fixation of mandibular fracturesReflection of vestibular flap and dissection around mental bundle and fracture reduction and fixation with 2 miniplates |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with displaced mandibular parasymphysis or body fracture in the mental nerve region
- Indicated for open reduction and internal fixation (ORIF)
Key exclusion criteria (4 listed)
- Patients with systemic diseases that affect bone healing
- Fractures with crushed mental foramen
- Comminuted fractures where fixation is difficult
- Patients with anatomical variations (e.g., bifid inferior alveolar or mental nerve), based on preoperative CT nerve tracing
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 |
|---|---|---|
| Modified Omega bone plate for fixation of mandibular fractures in mental foramen regionReflection of vestibular flap without dissection around mental bundle and fracture reduction and fixation with 3D Modified Omega bone plate | Procedure or surgery | Modified Omega bone plate used for fixation of mandibular fractures in mental foramen region |
| Conventional miniplates for fixation of mandibular fracturesReflection of vestibular flap with dissection around mental bundle and fracture reduction and fixation with 2 miniplates | Procedure or surgery | Conventional miniplates used for fixation of mandibular fractures in mental foramen region |
Primary outcome
Pain intensity measured using Visual Analogue Scale (VAS)
Time frame: At 1 day, 3 days, 1 week, and 1 month postoperatively
Pain will be assessed using a 10-cm Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
6 secondary outcomes
Facial edema measured using linear facial measurements
Time frame: At 1 day, 3 days, 1 week
Neurosensory function assessed by two point discrimination test
Time frame: Up to 3 months
Maximal Interincisal Opening (MIO)
Time frame: Preoperative, and postoperative day 1, day 3, 1 week, and 1 month
Occlusion Status
Time frame: Postoperative 1 week and 1 month
Operation Time
Time frame: Intraoperative
Interfragmentary Gap
Time frame: 1 day Postoperative
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 3 Oct 2025.
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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.
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 Modified Omega bone plate for fixation of mandibular fractures in mental foramen region and Conventional miniplates for fixation of mandibular fractures in people with Mandibular Fractures and Fracture in Mental Nerve Region, 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 2 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 3 Oct 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?
Pain intensity measured using Visual Analogue Scale (VAS) (time frame: At 1 day, 3 days, 1 week, and 1 month 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 3 Oct 2025.