Fracture MandibleNCT03466190
Clinical Assessment of Computer-assisted PEEK Versus Conventional Titanium Plates on Mandibular Body Fractures
A study testing Titanium plate fixation and Custom made PEEK plate fixation in people with Fracture Mandible and Mandibular Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fracture Mandible, Mandibular Fractures
- What is being tested?
- Titanium plate fixation and Custom made PEEK plate fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2017to 2 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing major surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance.
Who cannot join
- Patients with physical and psychological intolerance. Because psychological stress will affect the immune system and general health.
- Patients with systemic diseases like uncontrolled diabetes mellitus. Because uncontrolled diabetes mellitus has a negative impact on normal bone healing.
- Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
- Patient with bad oral hygiene. As it has an influence on normal osseous healing
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine -Cairo University
Cairo, Giza Governorate, 12613
Rofaida A Ahmad, MSc, 01099669299, ro_fy_at@yahoo.com
Khaled Amr, PhD, 01006029031, khaledamr82@hotmail.com
About this study
Official title: Clinical Assessment of Postoperative Occlusion in Patient With Mandibular Body Fractures Reduced and Fixed With Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Conventional Titanium Plates (RCT)
Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.
Read the detailed description
Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.
Inclusion criteria:
All subjects were required:
- Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing major surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance.
Exclusion criteria:
- Patients with high risk systemic diseases like uncontrolled diabetes . As uncontrolled diabetes has a negative impact on normal bone healing.
- Patients with old fractures. As they will affect accuracy of reduction of the fractured segments.
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity.
Interventions:
Eligible patients will be randomized in equal proportions between the study group (PEEK custom made plates) and the control group (titanium plates).
A- Computer-assisted PEEK custom made plates:
- All cases will undergo surgery under general anesthesia.
- Exposure of the fractured segments will be done using a standardized surgical approach.
- The fractured segments will be reduced in normal anatomic position guided by customized plate.
- Fracture fragments will be fixed using PEEK custom made plate utilizing 2.0 mm screws.
B- Conventional titanium plates:
- All cases will undergo surgery under general anesthesia.
- Exposure of the fractured segments will be done using a standardized surgical approach.
- Inter-maxillary fixation will be done.
- The fractured segments will be reduced in normal anatomic position guided by occlusion.
- The fracture fragments will be fixed using 2.3 titanium plate on the inferior border and 2.0 titanium plate on the superior border utilizing bone screws.
Follow up:
Clinical evaluation will be performed at the first week postoperative. Computed tomography will be performed at the first week postoperative then patients will be recalled for clinical evaluation every week for one month. Final follow up visit will be at 3 months postoperative.
- Conditions
- Fracture Mandible, Mandibular Fractures
- Being tested
- Titanium plate fixation, Custom made PEEK plate fixation
- Keywords
- Mandibular body fractures, PEEK plates, titanium plates.
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium plate fixationProcedure or surgery
Also called Conventional titanium plates
Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using conventional titanium plates will be performed.
Custom made PEEK plate fixationProcedure or surgery
Also called Computer-assisted PEEK plate fixation
Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using custom made PEEK plates will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Custom made PEEK plate fixation | Experimental | Open Reduction Internal Fixation using Custom made PEEK plates. Receives: Procedure: Custom made PEEK plate fixation |
| Titanium plate fixation | Active comparator | Open Reduction Internal Fixation using conventional titanium plating system. Receives: Procedure: Titanium plate fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative occlusion
Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS)
(0-10)
Measured: 1 month postoperative
Secondary outcomes (4)
Accuracy of the planned reduction
The accuracy of computer assisted PEEK custom made plates in open reduction and
internal fixation of mandibular body fractures will be assessed using Mimics software, measuring unit (mm)
Measured: 1st week
Wound dehiscence
Wound infection will be assessed via clinical assessment, measuring unit (Binary yes/no)
Measured: 1 month postoperative
The need for 2nd surgery
Redo surgery will be assessed via clinical assessment, measuring unit (Binary yes/no)
Measured: 1 month postoperative
Operative time
Surgical time will be assessed via clinical assessment, measuring unit (hours)
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start2 Aug 2017
- Primary completion2 Mar 2019 (estimated)
- Study completion2 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture MandibleStudies 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
- Model description
- * A Randomized clinical trial. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: Both groups receiving treatment. * Parallel group study: Each group of patients receives a single treatment simultaneously.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rofaida Atef Atef, Cairo University
- Investigators
- Khaled Amr, PhD, Study director, Faculty of Oral and Dental Medicine -Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466190
- Sponsor's protocol ID
- CEBD-CU-2018-02-27
- Status last verified
- Mar 2018
- First submitted
- 2 Mar 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Postoperative Occlusion in Patient With Mandibular Body Fractures Reduced and Fixed With Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Conventional Titanium Plates (RCT)
- ClinicalTrials.gov ID
- NCT03466190
- Acronym / sponsor ID
- CEBD-CU-2018-02-27
- Conditions
- Fracture Mandible, Mandibular Fractures
- Keywords
- Mandibular body fractures, PEEK plates, titanium plates.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 2 Mar 2019 (estimated)
- Study completion
- 2 Mar 2019 (estimated)
- First posted
- 15 Mar 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.
Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.
Detailed description
Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.
Inclusion criteria:
All subjects were required:
- Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing major surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance.
Exclusion criteria:
- Patients with high risk systemic diseases like uncontrolled diabetes . As uncontrolled diabetes has a negative impact on normal bone healing.
- Patients with old fractures. As they will affect accuracy of reduction of the fractured segments.
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity.
Interventions:
Eligible patients will be randomized in equal proportions between the study group (PEEK custom made plates) and the control group (titanium plates).
A- Computer-assisted PEEK custom made plates:
- All cases will undergo surgery under general anesthesia.
- Exposure of the fractured segments will be done using a standardized surgical approach.
- The fractured segments will be reduced in normal anatomic position guided by customized plate.
- Fracture fragments will be fixed using PEEK custom made plate utilizing 2.0 mm screws.
B- Conventional titanium plates:
- All cases will undergo surgery under general anesthesia.
- Exposure of the fractured segments will be done using a standardized surgical approach.
- Inter-maxillary fixation will be done.
- The fractured segments will be reduced in normal anatomic position guided by occlusion.
- The fracture fragments will be fixed using 2.3 titanium plate on the inferior border and 2.0 titanium plate on the superior border utilizing bone screws.
Follow up:
Clinical evaluation will be performed at the first week postoperative. Computed tomography will be performed at the first week postoperative then patients will be recalled for clinical evaluation every week for one month. Final follow up visit will be at 3 months postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * A Randomized clinical trial. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: Both groups receiving treatment. * Parallel group study: Each group of patients receives a single treatment simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Custom made PEEK plate fixation | Experimental | Procedure: Custom made PEEK plate fixationOpen Reduction Internal Fixation using Custom made PEEK plates. |
| Titanium plate fixation | Active comparator | Procedure: Titanium plate fixationOpen Reduction Internal Fixation using conventional titanium plating system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing major surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance.
Key exclusion criteria (4 listed)
- Patients with physical and psychological intolerance. Because psychological stress will affect the immune system and general health.
- Patients with systemic diseases like uncontrolled diabetes mellitus. Because uncontrolled diabetes mellitus has a negative impact on normal bone healing.
- Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
- Patient with bad oral hygiene. As it has an influence on normal osseous healing
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 |
|---|---|---|
| Titanium plate fixationAlso: Conventional titanium platesUnder General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using conventional titanium plates will be performed. | Procedure or surgery | Titanium plate fixation |
| Custom made PEEK plate fixationAlso: Computer-assisted PEEK plate fixationUnder General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using custom made PEEK plates will be performed. | Procedure or surgery | Custom made PEEK plate fixation |
Primary outcome
Postoperative occlusion
Time frame: 1 month postoperative
Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS) (0-10)
4 secondary outcomes
Accuracy of the planned reduction
Time frame: 1st week
Wound dehiscence
Time frame: 1 month postoperative
The need for 2nd surgery
Time frame: 1 month postoperative
Operative time
Time frame: During operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Open reduction and rigid internal fixation of mandibular condylar fractures by an intraoral approach: a long-term follow-up study of 15 patientsLink provided by the sponsor.
- Accuracy of the Computer-Aided Surgical Simulation (CASS) System in the Treatment of Patients With Complex Craniomaxillofacial Deformity: A Pilot Study.Link provided by the sponsor.
- A Comparative Evaluation of Fixation Techniques in Anterior Mandibular Fractures Using 2.0 mm Monocortical Titanium Miniplates Versus 2.4 mm Cortical Titanium Lag ScrewsLink provided by the sponsor.
- Titanium osteosynthesis hardware in maxillofacial trauma surgery: to remove or remain? A retrospective study.Link provided by the sponsor.
- Camerani, et al. Reconstruction of frontal bone using specific implant polyether-ether-ketoneLink provided by the sponsor.
- The effect of diabetes mellitus on osseous healing.Link provided by the sponsor.
- 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.
Khaled Amr, PhD study director
Faculty of Oral and Dental Medicine -Cairo 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 Titanium plate fixation and Custom made PEEK plate fixation in people with Fracture Mandible and 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 5 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 15 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rofaida A Ahmad, MSc (+201099669299, ro_fy_at@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative occlusion (time frame: 1 month postoperative). 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 15 Mar 2018.