Mandible FractureNCT03839368
Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates
A study testing fixation of angle fracture in people with Mandible Fracture, run by Cairo University.
Trial summary
In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable fixation than two conventional miniplates? Many studies have been conducted to compare between different techniques of fixation used in angle fracture fixation. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandible Fracture
- What is being tested?
- fixation of angle fracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Apr 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with unilateral angle fracture.
- Patients free from any systemic disease \& bone metabolism diseases.
- No sex predilection
- Age range ( 15-70)
Who cannot join
- Comminuted fragmented \& infected angle fractures.
- Bilateral angle fracture.
- Systemic diseases.
- bone metabolism diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Conventional Miniplates: Randomized Clinical Trial
In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable fixation than two conventional miniplates? Many studies have been conducted to compare between different techniques of fixation used in angle fracture fixation. The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages \& simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.
Read the detailed description
In the past two decades, rigid internal fixation with miniplate has become the standard treatment modality in the management of mandibular fracture.
The optimal management of mandibular angle fractures remains controversial, thus continuous experimental \& clinical studies are being conducted to determine the best miniplate design which will provide the best postoperative stability \& resistance to mechanical function.
Since Michelet et al.\& Champy et al. recommended the use of a single (4-6 holes) monocortical plate , it become an acceptable method for angle fractures fixation.
Several surgeons have documented low complication rates with (Champy technique).But, according to the most recent experimental \& clinical studies, the stability provided by the miniplate fixation has become a point of debate among surgeons.Many researchers have argued that internal fixation with a passive miniplate along the external oblique line, following Champy's ideal osteosynthesis line principle, produces a tension effect that may yield a failure of osteosynthesis \& gap at inferior border of the mandible.And that pushed researches to conduct more studies to evaluate many plate \& screw systems and even suggest new designs for better stable postoperative results.
In 2014, B.T.Suer et al, designed a new noncompression 3D miniplates , basically it has one straight section and two lateral extensions. The straight section of this new design, which has four holes, was adapted to the superior border of the external oblique ridge \& provides similar advantages to the Champy technique (an intraoral approach, a single miniplate, \& the use of monocortical screws) .And the two lateral extensions, with one hole each, were then bent over to adapt to the buccal cortex of the ascending ramus along the external oblique ridge to resist lateral \& torsional forces.
Fresh, frozen cadavers of 15 healthy sheep were obtained for this study, sheep were used in this study owing to the similarities in size \& thickness to the human mandible. All of the mandibles were stripped of their soft tissues \& sectioned through the midline, between the central incisors. 30 hemimandibles were randomly divided into two groups , these groups were then fixed with two different plating techniques (the new design \& one conventional miniplates). And they were all examined for stability and resistance to mechanical forces (vertical, lateral, or tensile).
The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages \& simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. These findings are correlated to those of in vitro biomechanical study done by Alkan et al. that showed that Champy technique has less favourable biomechanical behaviour than biplanar fixation and 3D strut plate. In addition the new plate provide greater stability when subjected to lateral displacing forces.
More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.
- Conditions
- Mandible Fracture
- Being tested
- fixation of angle fracture
- Keywords
- 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.
fixation of angle fractureProcedure or surgery
open reduction and internal fixation of angle fracture
| Study group | Role | What they receive |
|---|---|---|
| K plate | Experimental | fixation of angle fracture using K plate versus two miniplates Receives: Procedure: fixation of angle fracture |
| Conventional two miniplates | Active comparator | fixation of angle fracture using K plate versus two miniplates Receives: Procedure: fixation of angle fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of angle fracture fixation
Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT \& after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique.
Bone density will be measured by Hounsfield unit at fracture site immediate postoperative \& after 3 months using F.B.CT.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startApr 2020 (estimated)
- Primary completion11 Apr 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Mahmoud Ahmed Mohamed, Cairo University
- Investigators
- Hagar Mohamed, BDS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839368
- Sponsor's protocol ID
- CEBD-CU-2019-02-03
- Status last verified
- Apr 2019
- First submitted
- 11 Feb 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suer BT, Kocyigit ID, Kaman S, Tuz HH, Tekin U, Atil F. Biomechanical evaluation of a new design titanium miniplate for the treatment of mandibular angle fractures. Int J Oral Maxillofac Surg. 2014 Jul;43(7):841-5. doi: 10.1016/j.ijom.2014.01.011. Epub 2014 Feb 24.
PubMed 24582290El-Sherif HM, Ali S, Talaat M, Mubarak F. Stability and Clinical Outcomes of Angle Fracture Fixation Using Sagittal Split Plate (SSOP) Versus Two Miniplates: Randomized Clinical Trial. J Maxillofac Oral Surg. 2024 Feb;23(1):107-113. doi: 10.1007/s12663-022-01817-z. Epub 2022 Nov 16.
PubMed 38312972
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Conventional Miniplates: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03839368
- Acronym / sponsor ID
- CEBD-CU-2019-02-03
- Conditions
- Mandible Fracture
- Keywords
- angle fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- 11 Apr 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 15 Feb 2019 (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.
In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable fixation than two conventional miniplates? Many studies have been conducted to compare between different techniques of fixation used in angle fracture fixation. The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages \& simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.
Detailed description
In the past two decades, rigid internal fixation with miniplate has become the standard treatment modality in the management of mandibular fracture.
The optimal management of mandibular angle fractures remains controversial, thus continuous experimental \& clinical studies are being conducted to determine the best miniplate design which will provide the best postoperative stability \& resistance to mechanical function.
Since Michelet et al.\& Champy et al. recommended the use of a single (4-6 holes) monocortical plate , it become an acceptable method for angle fractures fixation.
Several surgeons have documented low complication rates with (Champy technique).But, according to the most recent experimental \& clinical studies, the stability provided by the miniplate fixation has become a point of debate among surgeons.Many researchers have argued that internal fixation with a passive miniplate along the external oblique line, following Champy's ideal osteosynthesis line principle, produces a tension effect that may yield a failure of osteosynthesis \& gap at inferior border of the mandible.And that pushed researches to conduct more studies to evaluate many plate \& screw systems and even suggest new designs for better stable postoperative results.
In 2014, B.T.Suer et al, designed a new noncompression 3D miniplates , basically it has one straight section and two lateral extensions. The straight section of this new design, which has four holes, was adapted to the superior border of the external oblique ridge \& provides similar advantages to the Champy technique (an intraoral approach, a single miniplate, \& the use of monocortical screws) .And the two lateral extensions, with one hole each, were then bent over to adapt to the buccal cortex of the ascending ramus along the external oblique ridge to resist lateral \& torsional forces.
Fresh, frozen cadavers of 15 healthy sheep were obtained for this study, sheep were used in this study owing to the similarities in size \& thickness to the human mandible. All of the mandibles were stripped of their soft tissues \& sectioned through the midline, between the central incisors. 30 hemimandibles were randomly divided into two groups , these groups were then fixed with two different plating techniques (the new design \& one conventional miniplates). And they were all examined for stability and resistance to mechanical forces (vertical, lateral, or tensile).
The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages \& simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. These findings are correlated to those of in vitro biomechanical study done by Alkan et al. that showed that Champy technique has less favourable biomechanical behaviour than biplanar fixation and 3D strut plate. In addition the new plate provide greater stability when subjected to lateral displacing forces.
More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| K plate | Experimental | Procedure: fixation of angle fracturefixation of angle fracture using K plate versus two miniplates |
| Conventional two miniplates | Active comparator | Procedure: fixation of angle fracturefixation of angle fracture using K plate versus two miniplates |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with unilateral angle fracture.
- Patients free from any systemic disease \& bone metabolism diseases.
- No sex predilection
- Age range ( 15-70)
Key exclusion criteria (4 listed)
- Comminuted fragmented \& infected angle fractures.
- Bilateral angle fracture.
- Systemic diseases.
- bone metabolism diseases
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 |
|---|---|---|
| fixation of angle fractureopen reduction and internal fixation of angle fracture | Procedure or surgery | Conventional two miniplates, K plate |
Primary outcome
Stability of angle fracture fixation
Time frame: 3 months
Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT \& after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique. Bone density will be measured by Hounsfield unit at fracture site immediate postoperative \& after 3 months using F.B.CT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Background: PubMed 24582290Suer BT, Kocyigit ID, Kaman S, Tuz HH, Tekin U, Atil F. Biomechanical evaluation of a new design titanium miniplate for the treatment of mandibular angle fractures. Int J Oral Maxillofac Surg. 2014 Jul;43(7):841-5. doi: 10.1016/j.ijom.2014.01.011. Epub 2014 Feb 24.
- Derived from this study: PubMed 38312972El-Sherif HM, Ali S, Talaat M, Mubarak F. Stability and Clinical Outcomes of Angle Fracture Fixation Using Sagittal Split Plate (SSOP) Versus Two Miniplates: Randomized Clinical Trial. J Maxillofac Oral Surg. 2024 Feb;23(1):107-113. doi: 10.1007/s12663-022-01817-z. Epub 2022 Nov 16.
- 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.
Hagar Mohamed, BDS principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing fixation of angle fracture 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 4 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 4 Jun 2019. 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 Hagar A Mohamed, BDS (01016799911, hagar_elsherif92@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of angle fracture fixation (time frame: 3 months). 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 NCT03839368, which also lists 2 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 4 Jun 2019.