Mandibular FracturesNCT07904897
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
A study testing Open reduction and Internal fixation of a mandibular body fracture in people with Mandibular Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this randomized controlled clinical trial is to evaluate and compare the bone mineral density (BMD) recovery following open reduction and internal fixation (ORIF) of mandibular body fractures using patient-specific plates versus conventional plates. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Open reduction and Internal fixation of a mandibular body fracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral or bilateral mandibular body fracture requiring open reduction and internal fixation (ORIF), presenting either isolated or concurrently with other maxillofacial, midface, or other mandibular fractures.
- Patients in good general health who are medically cleared to undergo major maxillofacial surgery under general anesthesia.
Who cannot join
- Presence of comminuted fractures or pre-existing malunions at the fracture site.
- Patients with high-risk systemic diseases or any medical conditions that contraindicate the administration of general anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry- Cairo University
Cairo, Giza Governorate, 11553
Dina Y Girgis, +201278061226, dina.yacoub@dentistry.cu.edu.eg
Dina Y Girgis
About this study
Official title: Optimized Osteosynthesis: A Comparative Analysis of Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates (A Randomized Controlled Clinical Trial)
The goal of this randomized controlled clinical trial is to evaluate and compare the bone mineral density (BMD) recovery following open reduction and internal fixation (ORIF) of mandibular body fractures using patient-specific plates versus conventional plates. Bone density at the fracture site will be quantified using Hounsfield Units (HU) on computed tomography (CT) scans.
The main question it aims to answer is: Do patient-specific plates provide a superior recovery of bone mineral density at the fracture site compared to conventional plates in patients undergoing fixation for mandibular body fractures?
Read the detailed description
This parallel-group, randomized controlled clinical trial evaluates the efficacy of patient-specific (custom-designed) fixation plates compared to conventional plates regarding bone mineral density recovery in mandibular body fractures.
Upon consenting to participate, eligible patients requiring open reduction and internal fixation (ORIF) for mandibular body fractures will be randomly assigned to one of two groups:
- Group I (Intervention): Patients will receive patient-specific titanium plates pre-fabricated utilizing computer-aided design and computer-aided manufacturing (CAD/CAM) based on preoperative 3D computed tomography (CT) data.
- Group II (Control): Patients will receive conventional, standard stock titanium plates adapted manually during surgery.
All surgical procedures will be standardized and performed under general anesthesia by the same surgical team.
Radiological Assessment of Bone Density:
The primary outcome, bone mineral density recovery at the fracture site, will be analyzed using Hounsfield Units (HU). Patients will undergo multi-slice CT scanning at baseline (within 1 week) and at 6 months postoperatively to assess the recovery.
- Conditions
- Mandibular Fractures
- Being tested
- Open reduction and Internal fixation of a mandibular body fracture
- Keywords
- Mandibular Body Fracture, Patient-Specific Plates, Conventional plates, Bone Mineral Density
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and Internal fixation of a mandibular body fractureProcedure or surgery
Patient-Specific titanium plates designed using virtual 3D planning software and fabricated via computer-aided manufacturing to match the patient's precise pre-injury mandibular anatomy.
Open reduction and Internal fixation of a mandibular body fractureProcedure or surgery
Commercially available, standard stock titanium plates will be adapted and bent manually by the surgeon during the operation to fit the patient's mandibular anatomy.
| Study group | Role | What they receive |
|---|---|---|
| Fixation of mandibular body fractures with patient-specific titanium plates. | Experimental | Patients in this group will undergo open reduction and internal fixation (ORIF) using custom-designed titanium plates. The plates are pre-fabricated utilizing computer-aided design and computer-aided manufacturing (CAD/CAM) based on the patient's preoperative 3D computed tomography (CT) data. Receives: Procedure: Open reduction and Internal fixation of a mandibular body fracture |
| Fixation of mandibular body fractures with conventional plates. | Active comparator | Patients in this group will undergo standard open reduction and internal fixation (ORIF) using commercially available, standard stock titanium plates. Receives: Procedure: Open reduction and Internal fixation of a mandibular body fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Bone mineral density recovery at the fracture site, will be analyzed using Hounsfield Units (HU).
Measured: Patients will undergo multi-slice CT scanning at baseline (within 1 week) and at 6 months postoperatively to assess the recovery.
Secondary outcomes (2)
Postoperative occlusion
Number of participants achieving a satisfactory occlusion, defined as meeting three criteria simultaneously: dental midline deviation ≤ 1 mm, bilateral normal canine relationship, and bilateral normal molar relationship. Failure in any criterion is classified as unsatisfactory.
Measured: One week postoperatively
Incidence of Postoperative Neurosensory Dysfunction
The number of participants who develop neurosensory dysfunction. Sensation is evaluated using the Two-Point Discrimination (2PD) test. Neurosensory dysfunction is defined as a binary categorical outcome where a participant fails to distinguish two distinct points at the standard clinical threshold (≤ 5 mm). Participants who require a distance greater than 5 mm to discriminate the two points are marked as having neurosensory dysfunction.
Measured: One week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start12 Oct 2026
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Yacoub Girgis, Cairo University
- Investigators
- Rofaida A Abbas, PhD, Study director, Associate ProfessorNahla M Awadallah, PhD, Study director, Associate ProfessorDina Y Girgis, Principal investigator, Assistant Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904897
- Sponsor's protocol ID
- CU-??-4-26
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jadhav A, Mundada B, Deshmukh R, Bhutekar U, Kala A, Waghwani K, Mishra A. Mandibular Ramus Fracture: An Overview of Rare Anatomical Subsite. Plast Surg Int. 2015;2015:954314. doi: 10.1155/2015/954314. Epub 2015 Nov 3.
PubMed 26613050Leathers R, Le AD, Black E, McQuirter JL. Orofacial injury in underserved minority populations. Dent Clin North Am. 2003 Jan;47(1):127-39. doi: 10.1016/s0011-8532(02)00053-8.
PubMed 12519010Scolozzi P, Richter M. Treatment of severe mandibular fractures using AO reconstruction plates. J Oral Maxillofac Surg. 2003 Apr;61(4):458-61. doi: 10.1053/joms.2003.50087.
PubMed 12684963Natu SS, Pradhan H, Gupta H, Alam S, Gupta S, Pradhan R, Mohammad S, Kohli M, Sinha VP, Shankar R, Agarwal A. An epidemiological study on pattern and incidence of mandibular fractures. Plast Surg Int. 2012;2012:834364. doi: 10.1155/2012/834364. Epub 2012 Nov 8.
PubMed 23227327Michelet FX, Deymes J, Dessus B. Osteosynthesis with miniaturized screwed plates in maxillo-facial surgery. J Maxillofac Surg. 1973 Jun;1(2):79-84. doi: 10.1016/s0301-0503(73)80017-7. No abstract available.
PubMed 4520558Kushner GM, Alpert B. Open reduction and internal fixation of acute mandibular fractures in adults. Facial Plast Surg. 1998;14(1):11-21. doi: 10.1055/s-0028-1085298.
PubMed 10371890Kende PP, Wadewale M, Ranganath S, Desai H, Landge JS, Sarda A. An In Vitro Evaluation of a Novel Design Z Plate for Fixation of Mandibular Symphysis and Parasymphysis Fractures-A Finite Element Analysis. J Maxillofac Oral Surg. 2022 Sep;21(3):929-935. doi: 10.1007/s12663-021-01576-3. Epub 2021 Apr 26.
PubMed 36274868Liu Y, Wei B, Li Y, Gu D, Yin G, Wang B, Xu D, Zhang X, Kong D. The 3-dimensional miniplate is more effective than the standard miniplate for the management of mandibular fractures: a meta-analysis. Eur J Med Res. 2017 Feb 14;22(1):5. doi: 10.1186/s40001-017-0244-2.
PubMed 28196543Liu YF, Fan YY, Jiang XF, Baur DA. A customized fixation plate with novel structure designed by topological optimization for mandibular angle fracture based on finite element analysis. Biomed Eng Online. 2017 Nov 15;16(1):131. doi: 10.1186/s12938-017-0422-z.
PubMed 29141673Singh V, Puri P, Arya S, Malik S, Bhagol A. Conventional versus 3-dimensional miniplate in management of mandibular fracture: a prospective randomized study. Otolaryngol Head Neck Surg. 2012 Sep;147(3):450-5. doi: 10.1177/0194599812449437. Epub 2012 May 30.
PubMed 22647925Saleh HO, Moussa BG, Salah Eddin KA, Noman SA, Salah AM. Assessment of CAD/CAM Customized V Pattern Plate Versus Standard Miniplates Fixation in Mandibular Angle Fracture (Randomized Clinical Trial). J Maxillofac Oral Surg. 2023 Dec;22(4):995-1005. doi: 10.1007/s12663-023-02027-x. Epub 2023 Oct 27.
PubMed 38105847Pandey S, Yadav P, Roychoudhury A, Bhutia O, Goswami D. A randomized controlled trial to compare functional, combined rigid and functional and rigid fixation in double mandibular fractures. J Oral Biol Craniofac Res. 2022 Mar-Apr;12(2):233-237. doi: 10.1016/j.jobcr.2022.02.003. Epub 2022 Feb 22.
PubMed 35284226Wusiman P, Abasi K, Maimaitishawuti D, Moming A. Management of Mandibular Angle Fractures Using One Miniplate or Two Miniplate Fixation System: A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2019 Aug;77(8):1673.e1-1673.e11. doi: 10.1016/j.joms.2019.04.006. Epub 2019 Apr 12.
PubMed 31077670
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Osteosynthesis: A Comparative Analysis of Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07904897
- Acronym / sponsor ID
- CU-??-4-26
- Conditions
- Mandibular Fractures
- Keywords
- Mandibular Body Fracture, Patient-Specific Plates, Conventional plates, Bone Mineral Density
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Oct 2026 (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.
The goal of this randomized controlled clinical trial is to evaluate and compare the bone mineral density (BMD) recovery following open reduction and internal fixation (ORIF) of mandibular body fractures using patient-specific plates versus conventional plates. Bone density at the fracture site will be quantified using Hounsfield Units (HU) on computed tomography (CT) scans.
The main question it aims to answer is: Do patient-specific plates provide a superior recovery of bone mineral density at the fracture site compared to conventional plates in patients undergoing fixation for mandibular body fractures?
Detailed description
This parallel-group, randomized controlled clinical trial evaluates the efficacy of patient-specific (custom-designed) fixation plates compared to conventional plates regarding bone mineral density recovery in mandibular body fractures.
Upon consenting to participate, eligible patients requiring open reduction and internal fixation (ORIF) for mandibular body fractures will be randomly assigned to one of two groups:
- Group I (Intervention): Patients will receive patient-specific titanium plates pre-fabricated utilizing computer-aided design and computer-aided manufacturing (CAD/CAM) based on preoperative 3D computed tomography (CT) data.
- Group II (Control): Patients will receive conventional, standard stock titanium plates adapted manually during surgery.
All surgical procedures will be standardized and performed under general anesthesia by the same surgical team.
Radiological Assessment of Bone Density:
The primary outcome, bone mineral density recovery at the fracture site, will be analyzed using Hounsfield Units (HU). Patients will undergo multi-slice CT scanning at baseline (within 1 week) and at 6 months postoperatively to assess the recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixation of mandibular body fractures with patient-specific titanium plates. | Experimental | Procedure: Open reduction and Internal fixation of a mandibular body fracturePatients in this group will undergo open reduction and internal fixation (ORIF) using custom-designed titanium plates. The plates are pre-fabricated utilizing computer-aided design and computer-aided manufacturing (CAD/CAM) based on the patient's preoperative 3D computed tomography (CT) data. |
| Fixation of mandibular body fractures with conventional plates. | Active comparator | Procedure: Open reduction and Internal fixation of a mandibular body fracturePatients in this group will undergo standard open reduction and internal fixation (ORIF) using commercially available, standard stock titanium plates. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Unilateral or bilateral mandibular body fracture requiring open reduction and internal fixation (ORIF), presenting either isolated or concurrently with other maxillofacial, midface, or other mandibular fractures.
- Patients in good general health who are medically cleared to undergo major maxillofacial surgery under general anesthesia.
Key exclusion criteria (2 listed)
- Presence of comminuted fractures or pre-existing malunions at the fracture site.
- Patients with high-risk systemic diseases or any medical conditions that contraindicate the administration of general anesthesia.
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 |
|---|---|---|
| Open reduction and Internal fixation of a mandibular body fracturePatient-Specific titanium plates designed using virtual 3D planning software and fabricated via computer-aided manufacturing to match the patient's precise pre-injury mandibular anatomy. | Procedure or surgery | Fixation of mandibular body fractures with patient-specific titanium plates. |
| Open reduction and Internal fixation of a mandibular body fractureCommercially available, standard stock titanium plates will be adapted and bent manually by the surgeon during the operation to fit the patient's mandibular anatomy. | Procedure or surgery | Fixation of mandibular body fractures with conventional plates. |
Primary outcome
Bone density
Time frame: Patients will undergo multi-slice CT scanning at baseline (within 1 week) and at 6 months postoperatively to assess the recovery.
Bone mineral density recovery at the fracture site, will be analyzed using Hounsfield Units (HU).
2 secondary outcomes
Postoperative occlusion
Time frame: One week postoperatively
Incidence of Postoperative Neurosensory Dysfunction
Time frame: One week postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 26613050Jadhav A, Mundada B, Deshmukh R, Bhutekar U, Kala A, Waghwani K, Mishra A. Mandibular Ramus Fracture: An Overview of Rare Anatomical Subsite. Plast Surg Int. 2015;2015:954314. doi: 10.1155/2015/954314. Epub 2015 Nov 3.
- Background: PubMed 12519010Leathers R, Le AD, Black E, McQuirter JL. Orofacial injury in underserved minority populations. Dent Clin North Am. 2003 Jan;47(1):127-39. doi: 10.1016/s0011-8532(02)00053-8.
- Background: PubMed 12684963Scolozzi P, Richter M. Treatment of severe mandibular fractures using AO reconstruction plates. J Oral Maxillofac Surg. 2003 Apr;61(4):458-61. doi: 10.1053/joms.2003.50087.
- Background: PubMed 23227327Natu SS, Pradhan H, Gupta H, Alam S, Gupta S, Pradhan R, Mohammad S, Kohli M, Sinha VP, Shankar R, Agarwal A. An epidemiological study on pattern and incidence of mandibular fractures. Plast Surg Int. 2012;2012:834364. doi: 10.1155/2012/834364. Epub 2012 Nov 8.
- Background: PubMed 4520558Michelet FX, Deymes J, Dessus B. Osteosynthesis with miniaturized screwed plates in maxillo-facial surgery. J Maxillofac Surg. 1973 Jun;1(2):79-84. doi: 10.1016/s0301-0503(73)80017-7. No abstract available.
- Background: PubMed 10371890Kushner GM, Alpert B. Open reduction and internal fixation of acute mandibular fractures in adults. Facial Plast Surg. 1998;14(1):11-21. doi: 10.1055/s-0028-1085298.
- Background: PubMed 36274868Kende PP, Wadewale M, Ranganath S, Desai H, Landge JS, Sarda A. An In Vitro Evaluation of a Novel Design Z Plate for Fixation of Mandibular Symphysis and Parasymphysis Fractures-A Finite Element Analysis. J Maxillofac Oral Surg. 2022 Sep;21(3):929-935. doi: 10.1007/s12663-021-01576-3. Epub 2021 Apr 26.
- Background: PubMed 28196543Liu Y, Wei B, Li Y, Gu D, Yin G, Wang B, Xu D, Zhang X, Kong D. The 3-dimensional miniplate is more effective than the standard miniplate for the management of mandibular fractures: a meta-analysis. Eur J Med Res. 2017 Feb 14;22(1):5. doi: 10.1186/s40001-017-0244-2.
- Background: PubMed 29141673Liu YF, Fan YY, Jiang XF, Baur DA. A customized fixation plate with novel structure designed by topological optimization for mandibular angle fracture based on finite element analysis. Biomed Eng Online. 2017 Nov 15;16(1):131. doi: 10.1186/s12938-017-0422-z.
- Background: PubMed 22647925Singh V, Puri P, Arya S, Malik S, Bhagol A. Conventional versus 3-dimensional miniplate in management of mandibular fracture: a prospective randomized study. Otolaryngol Head Neck Surg. 2012 Sep;147(3):450-5. doi: 10.1177/0194599812449437. Epub 2012 May 30.
- Background: PubMed 38105847Saleh HO, Moussa BG, Salah Eddin KA, Noman SA, Salah AM. Assessment of CAD/CAM Customized V Pattern Plate Versus Standard Miniplates Fixation in Mandibular Angle Fracture (Randomized Clinical Trial). J Maxillofac Oral Surg. 2023 Dec;22(4):995-1005. doi: 10.1007/s12663-023-02027-x. Epub 2023 Oct 27.
- Background: PubMed 35284226Pandey S, Yadav P, Roychoudhury A, Bhutia O, Goswami D. A randomized controlled trial to compare functional, combined rigid and functional and rigid fixation in double mandibular fractures. J Oral Biol Craniofac Res. 2022 Mar-Apr;12(2):233-237. doi: 10.1016/j.jobcr.2022.02.003. Epub 2022 Feb 22.
- Mandibular Ramus Fracture: An Overview of Rare Anatomical SubsiteLink provided by the sponsor.
- Orofacial injury in underserved minority populationsLink provided by the sponsor.
- Treatment of severe mandibular fractures using AO reconstruction platesLink provided by the sponsor.
- An epidemiological study on pattern and incidence of mandibular fracturesLink provided by the sponsor.
- Osteosynthesis with miniaturized screwed plates in maxillo-facial surgeryLink provided by the sponsor.
- Open reduction and internal fixation of acute mandibular fractures in adultsLink provided by the sponsor.
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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.
Rofaida A Abbas, PhD study director
Associate Professor
Nahla M Awadallah, PhD study director
Associate Professor
Dina Y Girgis principal investigator
Assistant Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction and Internal fixation of a mandibular body fracture 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 2 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: looking for participants now, as of the sponsor's last update on 29 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Y Girgis (01278061226, dina.yacoub@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density (time frame: Patients will undergo multi-slice CT scanning at baseline (within 1 week) and at 6 months postoperatively to assess the recovery.). 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 NCT07904897, which also lists 13 linked publications.
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 29 Oct 2026.