Mandibular FracturesNCT03608891
Patient Specific Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures
A study testing Computer guided patient specific 3D titanium plate and Conventional titanium miniplates in people with Mandibular Fractures, run by Cairo University.
Trial summary
The aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Computer guided patient specific 3D titanium plate and Conventional titanium miniplates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jul 2019
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures
Who cannot join
- Patients with bilateral mandibular fractures
- Patients with other mandibular or maxillofacial fractures
- Comminuted fractures
- Medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Patient Specific Three-Dimensional Titanium Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures. (Randomized Clinical Trial)
The aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.
Read the detailed description
The study will be conducted on two groups:
Intervention group: patient specific three-dimensional titanium plates CBCT or CT scan will be performed for the patient, the dicom files will be imported into a surgical planning software , plates will then be designed virtually and sent for three-dimensional (3D) printing.
Control group: Conventional miniplates:
In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
- Conditions
- Mandibular Fractures
- Being tested
- Computer guided patient specific 3D titanium plate, Conventional titanium miniplates
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided patient specific 3D titanium plateDevice
Also called Intervention Arm
CBCT or CT scan will be done preoperatively and dicom files will be imported to mimics software to design and print the patient specific 3D titanium plate.
Conventional titanium miniplatesDevice
Also called Control arm
In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Conventional titanium miniplates Receives: Device: Conventional titanium miniplates |
| Intervention arm | Experimental | Patient specific 3D plates Receives: Device: Computer guided patient specific 3D titanium plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction measured with visual analogue scale (0-10)
patient satisfaction is defined as patient-reported outcome measure while the structures and processes of care can be measured by patient-reported experiences (30). Measured on a visual analogue scale (VAS) (29) of 0-10 ,with zero being unsatisfied and 10 being satisfied. Patient Satisfaction is assessed regarding prescence of pain, occlusal discrepencies and overall patient satisfaction.
Measured: Measured immediately after the surgery
Secondary outcomes (4)
Fracture gap distance
This is done using CBCT through measuring the fracture gap distance in millimeters to evaluate proper reduction and fixation
Measured: 0 and 3 months
Occlusal bite force
The biting force will be measured through the follow up visits (1 week,3 months) by the bite force recorder at the incisor region, right and left molar region. The measurement of the bite force will be undertaken using a portable type of occlusal force gauge (GM10, Nagano Keiki, Japan) called OCCLUSAL FORCE-METER GM10. (36)
Measured: 0 and 3 months
Operating time
The time of the surgery will be recorded using a stopwatch.
Measured: time of the surgery
Plate palpability
Measured during all follow up visits, by questioning the patient ,where the patient will be informed of the site of the plates ,and asked if he feels the plates are palpable ,and will be measured by binary measuring unit (yes/no) , also the plates will be palpated by the operator at follow up visits.
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startJul 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionJul 2019 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Adel, Cairo University
- Investigators
- Mohamed A Farid, PHD, Principal investigator, Cairo UniversityMohamed A Abd el Rasol, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608891
- Sponsor's protocol ID
- Patient specific plate
- Status last verified
- Jul 2018
- First submitted
- 10 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez R, Oeltjen JC, Thaller SR. A review of mandibular angle fractures. Craniomaxillofac Trauma Reconstr. 2011 Jun;4(2):69-72. doi: 10.1055/s-0031-1272903.
PubMed 22655117Goiato MC, Santos MR, Pesqueira AA, Moreno A, dos Santos DM, Haddad MF. Prototyping for surgical and prosthetic treatment. J Craniofac Surg. 2011 May;22(3):914-7. doi: 10.1097/SCS.0b013e31820f7f90.
PubMed 21558926Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92.
PubMed 22337427Talwar RM, Chemaly D. Information and computer technology in oral and maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2008 Feb;20(1):79-89. doi: 10.1016/j.coms.2007.09.006.
PubMed 18194740Edwards SP. Computer-assisted craniomaxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2010 Feb;22(1):117-34. doi: 10.1016/j.coms.2009.11.005.
PubMed 20159482Hassfeld S, Muhling J. Computer assisted oral and maxillofacial surgery--a review and an assessment of technology. Int J Oral Maxillofac Surg. 2001 Feb;30(1):2-13. doi: 10.1054/ijom.2000.0024.
PubMed 11289616Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. doi: 10.1097/01.scs.0000186306.32042.96.
PubMed 16327572Bell RB. Computer planning and intraoperative navigation in cranio-maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2010 Feb;22(1):135-56. doi: 10.1016/j.coms.2009.10.010.
PubMed 20159483Al-Abri R, Al-Balushi A. Patient satisfaction survey as a tool towards quality improvement. Oman Med J. 2014 Jan;29(1):3-7. doi: 10.5001/omj.2014.02.
PubMed 24501659Butts SC, Floyd E, Lai E, Rosenfeld RM, Doerr T. Reporting of Postoperative Pain Management Protocols in Randomized Clinical Trials of Mandibular Fracture Repair: A Systematic Review. JAMA Facial Plast Surg. 2015 Nov-Dec;17(6):440-8. doi: 10.1001/jamafacial.2015.1011.
PubMed 26335408Kumar ST, Saraf S, Devi SP. Evaluation of bite force after open reduction and internal fixation using microplates. J Dent (Tehran). 2013 Sep;10(5):466-77. Epub 2013 Sep 30.
PubMed 24910656Rodt T, Bartling SO, Zajaczek JE, Vafa MA, Kapapa T, Majdani O, Krauss JK, Zumkeller M, Matthies H, Becker H, Kaminsky J. Evaluation of surface and volume rendering in 3D-CT of facial fractures. Dentomaxillofac Radiol. 2006 Jul;35(4):227-31. doi: 10.1259/dmfr/22989395.
PubMed 16798916Manson PN, Markowitz B, Mirvis S, Dunham M, Yaremchuk M. Toward CT-based facial fracture treatment. Plast Reconstr Surg. 1990 Feb;85(2):202-12; discussion 213-4.
PubMed 2300626
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Three-Dimensional Titanium Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures. (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03608891
- Acronym / sponsor ID
- Patient specific plate
- Conditions
- Mandibular Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 1 Aug 2018 (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 aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.
Detailed description
The study will be conducted on two groups:
Intervention group: patient specific three-dimensional titanium plates CBCT or CT scan will be performed for the patient, the dicom files will be imported into a surgical planning software , plates will then be designed virtually and sent for three-dimensional (3D) printing.
Control group: Conventional miniplates:
In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Device: Conventional titanium miniplatesConventional titanium miniplates |
| Intervention arm | Experimental | Device: Computer guided patient specific 3D titanium platePatient specific 3D plates |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures
Key exclusion criteria (4 listed)
- Patients with bilateral mandibular fractures
- Patients with other mandibular or maxillofacial fractures
- Comminuted fractures
- Medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.
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 |
|---|---|---|
| Computer guided patient specific 3D titanium plateAlso: Intervention ArmCBCT or CT scan will be done preoperatively and dicom files will be imported to mimics software to design and print the patient specific 3D titanium plate. | Device | Intervention arm |
| Conventional titanium miniplatesAlso: Control armIn this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots. | Device | Control Arm |
Primary outcome
Patient Satisfaction measured with visual analogue scale (0-10)
Time frame: Measured immediately after the surgery
patient satisfaction is defined as patient-reported outcome measure while the structures and processes of care can be measured by patient-reported experiences (30). Measured on a visual analogue scale (VAS) (29) of 0-10 ,with zero being unsatisfied and 10 being satisfied. Patient Satisfaction is assessed regarding prescence of pain, occlusal discrepencies and overall patient satisfaction.
4 secondary outcomes
Fracture gap distance
Time frame: 0 and 3 months
Occlusal bite force
Time frame: 0 and 3 months
Operating time
Time frame: time of the surgery
Plate palpability
Time frame: 0 and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 22655117Perez R, Oeltjen JC, Thaller SR. A review of mandibular angle fractures. Craniomaxillofac Trauma Reconstr. 2011 Jun;4(2):69-72. doi: 10.1055/s-0031-1272903.
- Background: PubMed 21558926Goiato MC, Santos MR, Pesqueira AA, Moreno A, dos Santos DM, Haddad MF. Prototyping for surgical and prosthetic treatment. J Craniofac Surg. 2011 May;22(3):914-7. doi: 10.1097/SCS.0b013e31820f7f90.
- Background: PubMed 22337427Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92.
- Background: PubMed 18194740Talwar RM, Chemaly D. Information and computer technology in oral and maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2008 Feb;20(1):79-89. doi: 10.1016/j.coms.2007.09.006.
- Background: PubMed 20159482Edwards SP. Computer-assisted craniomaxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2010 Feb;22(1):117-34. doi: 10.1016/j.coms.2009.11.005.
- Background: PubMed 11289616Hassfeld S, Muhling J. Computer assisted oral and maxillofacial surgery--a review and an assessment of technology. Int J Oral Maxillofac Surg. 2001 Feb;30(1):2-13. doi: 10.1054/ijom.2000.0024.
- Background: PubMed 16327572Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. doi: 10.1097/01.scs.0000186306.32042.96.
- Background: PubMed 20159483Bell RB. Computer planning and intraoperative navigation in cranio-maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2010 Feb;22(1):135-56. doi: 10.1016/j.coms.2009.10.010.
- Results publication: PubMed 24501659Al-Abri R, Al-Balushi A. Patient satisfaction survey as a tool towards quality improvement. Oman Med J. 2014 Jan;29(1):3-7. doi: 10.5001/omj.2014.02.
- Results publication: PubMed 26335408Butts SC, Floyd E, Lai E, Rosenfeld RM, Doerr T. Reporting of Postoperative Pain Management Protocols in Randomized Clinical Trials of Mandibular Fracture Repair: A Systematic Review. JAMA Facial Plast Surg. 2015 Nov-Dec;17(6):440-8. doi: 10.1001/jamafacial.2015.1011.
- Results publication: PubMed 24910656Kumar ST, Saraf S, Devi SP. Evaluation of bite force after open reduction and internal fixation using microplates. J Dent (Tehran). 2013 Sep;10(5):466-77. Epub 2013 Sep 30.
- Results publication: PubMed 16798916Rodt T, Bartling SO, Zajaczek JE, Vafa MA, Kapapa T, Majdani O, Krauss JK, Zumkeller M, Matthies H, Becker H, Kaminsky J. Evaluation of surface and volume rendering in 3D-CT of facial fractures. Dentomaxillofac Radiol. 2006 Jul;35(4):227-31. doi: 10.1259/dmfr/22989395.
- 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 Farid, PHD principal investigator
Cairo University
Mohamed A Abd el Rasol, PhD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided patient specific 3D titanium plate and Conventional titanium miniplates in people with Mandibular Fractures, run by Cairo University.
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 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 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dina A Alei El Dine, Postgraduate (01285568850, dinaadelta3lab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction measured with visual analogue scale (0-10) (time frame: Measured immediately after the surgery). 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 NCT03608891, 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 1 Aug 2018.