Mandible FractureNCT03640039
Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.
A study testing 3d strut plate. in people with Mandible Fracture, run by Cairo University.
Trial summary
comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandible Fracture
- What is being tested?
- 3d strut plate.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2019to 1 Jun 2020
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible.
- Patient over 15 years old age 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 comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate .
- Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate in Two Groups One With IMMF and Anthor Without IMMF ;Randomized Clinical Trial.
comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.
Read the detailed description
Two group of patient with mandibular angle fracture indicated for open reduction and internal fixation ,first group will be fixed with 3d stut plate with post operative IMMF. Second group will be fixed with 3d strut plate with out post operative IMMF.
Eligble patients will be randomised in equal proportions between study group (3d strut plate with out post operative IMMF) and control group (3d strut plate with post operative IMMF).
A- 3D strut plate without post operative IMMF:
- Pre operative computed tomography will be done for patient.
- Intra operative :all cases will under go general anathesia.
- Exposure of the fracture segments using vestubular incision.
- Inter-maxillary fixation will be done.
- The fracture segment will be reduced in normal anatomic postion guided with occlusion.
- The fracture segment will be fixed in postion using 3d srut plate.
- Closure of surgical incision.
- Post operative computed tomograghy will be done for the patient.
- Patient will be dismissed from operation room without IMMF.
B- 3D strut with post operative IMMF:
- Pre operative computed tomography will be done for patient.
- Intra operative :all cases will under go general anathesia.
- Exposure of the fracture segments using vestubular incision.
- Inter-maxillary fixation will be done.
- The fracture segment will be reduced in normal anatomic postion guided with occlusion.
- The fracture segment will be fixed in postion using 3d srut plate.
- Closure of surgical incision.
- Post operative computed tomograghy will be done for the patient.
- Patient will be dismissed from operation room with IMMF for 15 days.
Follow up for both groups :
Clinical examination will be done at first week post operative and patients will be examined every week for one month. Last follow up visit will be after three months post operative.
- Conditions
- Mandible Fracture
- Being tested
- 3d strut plate.
- Keywords
- 3d strut plate, mandibular angle fracture
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d strut plate.Procedure or surgery
Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.
| Study group | Role | What they receive |
|---|---|---|
| study group: 3d strut plate fixation without post op IMMF. | Experimental | Open reduction and internal fixation with 3d strut plate without post operative IMMF. Receives: Procedure: 3d strut plate. |
| control group: 3d srut plate fixation with post op IMMF. | Active comparator | Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days. Receives: Procedure: 3d strut plate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
stability of fracture segments.
post operative bimanual manipulation of the fracture segment.
Measured: 15 days post operative.
Secondary outcomes (2)
inferior alveolar nerve injury.
measurment by:Neurosensory testing: patient will be asked if there was numbness without stimulus and on stroking the lower lip skin with afinger.The patient will be asked to grade the sensation present on an analog scale from 0 (no sensation) to 10 (completely normal sensation)
Measured: pre operative and 1 week post operative.
Accuracy of fracture reduction.
Post operative. Through computed tomography by measuring inter ramus distance using lingula as reference to measure.
Measured: one week post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start11 Jan 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mandible FractureStudies 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 Radomized clinical trial. * Parallel group study. * A trial will be carried out in hospital of oral and maxillofacial surgery department - faculty of dentistry cairo university. * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: both groups receiving treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khater tarek, Cairo University
- Investigators
- Hesham A Hakam, Prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640039
- Sponsor's protocol ID
- 2972018
- Status last verified
- Aug 2018
- First submitted
- 29 Jul 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kellman RM. Repair of mandibular fractures via compression plating and more traditional techniques: a comparison of results. Laryngoscope. 1984 Dec;94(12 Pt 1):1560-7.
PubMed 6503575Saman M, Kadakia S, Ducic Y. Postoperative maxillomandibular fixation after open reduction of mandible fractures. JAMA Facial Plast Surg. 2014 Nov-Dec;16(6):410-3. doi: 10.1001/jamafacial.2014.543.
PubMed 25232835Guimond C, Johnson JV, Marchena JM. Fixation of mandibular angle fractures with a 2.0-mm 3-dimensional curved angle strut plate. J Oral Maxillofac Surg. 2005 Feb;63(2):209-14. doi: 10.1016/j.joms.2004.03.018.
PubMed 15690289Farmand M. [Experiences with the 3-D miniplate osteosynthesis in mandibular fractures]. Fortschr Kiefer Gesichtschir. 1996;41:85-7. German.
PubMed 8755408Vineeth K, Lalitha RM, Prasad K, Ranganath K, Shwetha V, Singh J. "A comparative evaluation between single noncompression titanium miniplate and three dimensional titanium miniplate in treatment of mandibular angle fracture"--a randomized prospective study. J Craniomaxillofac Surg. 2013 Mar;41(2):103-9. doi: 10.1016/j.jcms.2012.05.015. Epub 2012 Jul 17.
PubMed 22809633Farmand M, Dupoirieux L. [The value of 3-dimensional plates in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1992;93(6):353-7. French.
PubMed 1475603Sadhwani BS, Anchlia S. Conventional 2.0 mm miniplates versus 3-D plates in mandibular fractures. Ann Maxillofac Surg. 2013 Jul;3(2):154-9. doi: 10.4103/2231-0746.119231.
PubMed 24205475Jain MK, Manjunath KS, Bhagwan BK, Shah DK. Comparison of 3-dimensional and standard miniplate fixation in the management of mandibular fractures. J Oral Maxillofac Surg. 2010 Jul;68(7):1568-72. doi: 10.1016/j.joms.2009.07.083. Epub 2010 Apr 22.
PubMed 20417012
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate in Two Groups One With IMMF and Anthor Without IMMF ;Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03640039
- Acronym / sponsor ID
- 2972018
- Conditions
- Mandible Fracture
- Keywords
- 3d strut plate, mandibular angle fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jan 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 21 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.
comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.
Detailed description
Two group of patient with mandibular angle fracture indicated for open reduction and internal fixation ,first group will be fixed with 3d stut plate with post operative IMMF. Second group will be fixed with 3d strut plate with out post operative IMMF.
Eligble patients will be randomised in equal proportions between study group (3d strut plate with out post operative IMMF) and control group (3d strut plate with post operative IMMF).
A- 3D strut plate without post operative IMMF:
- Pre operative computed tomography will be done for patient.
- Intra operative :all cases will under go general anathesia.
- Exposure of the fracture segments using vestubular incision.
- Inter-maxillary fixation will be done.
- The fracture segment will be reduced in normal anatomic postion guided with occlusion.
- The fracture segment will be fixed in postion using 3d srut plate.
- Closure of surgical incision.
- Post operative computed tomograghy will be done for the patient.
- Patient will be dismissed from operation room without IMMF.
B- 3D strut with post operative IMMF:
- Pre operative computed tomography will be done for patient.
- Intra operative :all cases will under go general anathesia.
- Exposure of the fracture segments using vestubular incision.
- Inter-maxillary fixation will be done.
- The fracture segment will be reduced in normal anatomic postion guided with occlusion.
- The fracture segment will be fixed in postion using 3d srut plate.
- Closure of surgical incision.
- Post operative computed tomograghy will be done for the patient.
- Patient will be dismissed from operation room with IMMF for 15 days.
Follow up for both groups :
Clinical examination will be done at first week post operative and patients will be examined every week for one month. Last follow up visit will be after three months post operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- * A Radomized clinical trial. * Parallel group study. * A trial will be carried out in hospital of oral and maxillofacial surgery department - faculty of dentistry cairo university. * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: both groups receiving treatment.
| Arm | Type | Receives |
|---|---|---|
| study group: 3d strut plate fixation without post op IMMF. | Experimental | Procedure: 3d strut plate.Open reduction and internal fixation with 3d strut plate without post operative IMMF. |
| control group: 3d srut plate fixation with post op IMMF. | Active comparator | Procedure: 3d strut plate.Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible.
- Patient over 15 years old age 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 (3 listed)
- Patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate .
- Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As 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.
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 |
|---|---|---|
| 3d strut plate.Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF. | Procedure or surgery | control group: 3d srut plate fixation with post op IMMF., study group: 3d strut plate fixation without post op IMMF. |
Primary outcome
stability of fracture segments.
Time frame: 15 days post operative.
post operative bimanual manipulation of the fracture segment.
2 secondary outcomes
inferior alveolar nerve injury.
Time frame: pre operative and 1 week post operative.
Accuracy of fracture reduction.
Time frame: one week post operative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Background: PubMed 6503575Kellman RM. Repair of mandibular fractures via compression plating and more traditional techniques: a comparison of results. Laryngoscope. 1984 Dec;94(12 Pt 1):1560-7.
- Background: PubMed 25232835Saman M, Kadakia S, Ducic Y. Postoperative maxillomandibular fixation after open reduction of mandible fractures. JAMA Facial Plast Surg. 2014 Nov-Dec;16(6):410-3. doi: 10.1001/jamafacial.2014.543.
- Background: PubMed 15690289Guimond C, Johnson JV, Marchena JM. Fixation of mandibular angle fractures with a 2.0-mm 3-dimensional curved angle strut plate. J Oral Maxillofac Surg. 2005 Feb;63(2):209-14. doi: 10.1016/j.joms.2004.03.018.
- Background: PubMed 8755408Farmand M. [Experiences with the 3-D miniplate osteosynthesis in mandibular fractures]. Fortschr Kiefer Gesichtschir. 1996;41:85-7. German.
- Background: PubMed 22809633Vineeth K, Lalitha RM, Prasad K, Ranganath K, Shwetha V, Singh J. "A comparative evaluation between single noncompression titanium miniplate and three dimensional titanium miniplate in treatment of mandibular angle fracture"--a randomized prospective study. J Craniomaxillofac Surg. 2013 Mar;41(2):103-9. doi: 10.1016/j.jcms.2012.05.015. Epub 2012 Jul 17.
- Background: PubMed 1475603Farmand M, Dupoirieux L. [The value of 3-dimensional plates in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1992;93(6):353-7. French.
- Background: PubMed 24205475Sadhwani BS, Anchlia S. Conventional 2.0 mm miniplates versus 3-D plates in mandibular fractures. Ann Maxillofac Surg. 2013 Jul;3(2):154-9. doi: 10.4103/2231-0746.119231.
- Background: PubMed 20417012Jain MK, Manjunath KS, Bhagwan BK, Shah DK. Comparison of 3-dimensional and standard miniplate fixation in the management of mandibular fractures. J Oral Maxillofac Surg. 2010 Jul;68(7):1568-72. doi: 10.1016/j.joms.2009.07.083. Epub 2010 Apr 22.
- Individual participant dataSharing planned: No
Related trials for Mandible Fracture
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Not yet recruiting
Clinical And Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures
Mandibular Angle Fractures, Mandibular Body Fractures
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
Pediatric Mandibular Fracture
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
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.
Hesham A Hakam, Prof study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing 3d strut plate. in people with Mandible Fracture, 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 5 inclusion and 3 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 21 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 Mohamed T khater, MSc (+201003854552, m_khater385@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stability of fracture segments. (time frame: 15 days post operative.). 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 NCT03640039, which also lists 8 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 21 Aug 2018.