Displaced Mandibular Angle FractureRCTsNCT01939015
Three Dimensional Versus Standard Miniplate In Fixation Of Mandibular Angle Fracture- A Prospective Randomized Controlled Clinical Trial
A study testing 3D titanium miniplate and Standard titanium miniplate- single non compression miniplate in people with Displaced Mandibular Angle Fracture, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the standard and 3D miniplates fixation in mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain, hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one method over the other. Read more about this study
- Who is it for?
- Ages 17 to 45 years
- Conditions the study is for
- Displaced Mandibular Angle Fracture
- What is being tested?
- 3D titanium miniplate and Standard titanium miniplate- single non compression miniplate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2013to Oct 2013
- 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 17 to 45 years
- All sexes
- Child, Adult
Who may be able to join
- Adults dentate patients (>17 years old) with displaced an angle mandibular fracture
- non infected non comminuted angle mandibular fracture
Who cannot join
- infected angle mandibular fracture
- atrophied mandibular fracture
- angle fracture with subcondylar fracture
- patients under 17 year
- gun shout injury associated fracture
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Oral and Maxillofacial SurgeryFaculty of Oral and Dental Medicine
Cairo, Giza Governorate, 17445
About this study
Official title: 3D Vs Standard Miniplate in Fixation of the MAFs
- The aim of this study is to compare the standard and 3D miniplates fixation in mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain, hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one method over the other.
- Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients returned 7 days after surgery for clinical evaluation . The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing. the complications encountered will be recorded and treated. The clinical evaluations will be performed by 1 surgeon at each institution.
- The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for infection will based on either of the following conditions: 1) purulent discharge from an incision and 2) serosanguineous drainage and a wound culture positive for a known pathogen. All the patients will evaluated postoperatively by a single assessor.
- Statically analysis :
Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤ 0.05 will be considered statistically significant.
Read the detailed description
- This study will include 20 dentate patients with mandibular angle fracture whom presented for treatment at Department Of Oral and Maxillofacial Surgery, Faculty Of Oral And Dental Medicine, Cairo University.
- The patients after inclusion will be randomly divided into either Group A or Group B. Group A consist of 10 patients underwent open reduction with internal fixation of the angle mandibular fracture with 3D titanium miniplates whereas Group B consist of 10 patients underwent open reduction with internal fixation of the mandibular angle fracture with standard miniplate using a single miniplate technique of Champy's principle of osteosynthesis.
- Inclusion criteria: 1) Age group between 15-40 years. 2) patients with non-infected and non-comminuted mandibular angle fractures 3) surgical treatment provided within 7 days of injury via open reduction and internal fixation (ORIF) by an extra oral approach 4) no use of postsurgical maxillomandibular fixation (MMF) postoperatively 5) a 1-week duration of postsurgical oral antibiotic therapy.
- Exclusion criteria : 1) the fracture was infected at the time of treatment, 2) medical conditions that could possibly have interfered with healing (diabetes, chemotherapy, etc.) or prevented general anesthesia.
- Preoperative Evaluation
Careful extra and intraoral clinical examinations will be perform on all patients. The presence of lacerations, swelling, ecchymosis, occlusal disturbances, or broken, avulsed, or missing teeth will noted, and the mandibular movements, maximal interincisal opening, and nerve function will be recorded. Palpation of the mandible for areas of tenderness, segment mobility, bony crepitus, and tooth mobility will be also perform . Radiographic images (panoramic and posteroanterior) will be taken to evaluate the fracture. Immediately preoperatively, each patient will be given a standard dose of 1.5 g of Unasyn* and 8 mg of Epidron** intravenously.
-Surgical Technique:
After placement of arch bars, the fracture line will be exposed through extraoral a submandibular (Risdon) incision. Only the amount of soft tissue stripping necessary to visualize, reduce, and stabilize the fracture will be performed. Mobile teeth or teeth with apices that will be exposed in the fracture will be removed.
All a fracture site will be identified, reduced, and after obtaining satisfactory occlusion, temporary maxillomandibular fixation will be placed using either Erich's arch bar or Ivy loop eyelet wiring.
Fixation in group A will be achieved using a 3D curved strut miniplate* (Fig 1) , installed and stabilized with monocortical screws. The 3D plate will be place in such a way that a horizontal bar is perpendicular and a vertical bar is parallel to the fracture line. While in group B fixation will be perform by A single non compression miniplate with 4-hole 2-mm using 2-mm monocortical screws.
In both group fixation will be carried out through extraoral submandibular approach and placed in the neutral zone of the mandibular angle (between tension and compression areas).
After fixation of the fracture, intermaxillary fixation will be removed . And the incisions will be close in layers by absorbable suture while the skin closed by 5-0 nylon sutures. No drains will placed. and the occlusion will checked .
-Postsurgical Management:
Antibiotics will be continued through the preoperative period and for 5 to 7 days after surgery. And other medication to control swelling and pain will be administered. Chlorhexidine mouth rinse will be provided for all patient until removal of arch bars. Soft diet will be strongly recommend for 2 weeks then Pasty diet will be gradually regained .
-Postoperative Evaluation :
Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients returned 7 days after surgery for clinical evaluation . The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing. the complications encountered will be recorded by treatment scoring system and treated. The clinical evaluations will be performed by 1 surgeon at each institution.
The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for infection will based on either of the following conditions: 1) purulent discharge from an incision and 2) serosanguineous drainage and a wound culture positive for a known pathogen. All the patients will evaluated postoperatively by a single assessor.
-Statically analysis :
Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤ 0.05 will be considered statistically significant.
- Conditions
- Displaced Mandibular Angle Fracture
- Being tested
- 3D titanium miniplate, Standard titanium miniplate- single non compression miniplate
- Keywords
- 3D miniplate, angle mandibular fracture, champy technique, internal rigid fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D titanium miniplateDevice
Also called Universal Mandible System, Stryker-Lei binger, Freiburg, Germany
for study group by using 3D titanium miniplate under open reduction under general anesthesia with mono cortical screw, while in control group single titanium miniplate at superior border with mono cortical screw according to ideal line of osteosynthesis of champy
Standard titanium miniplate- single non compression miniplateDevice
Also called Champy technique (single non compression miniplate)
single non compression miniplate placed at superior border with monocortical screws via intraoral approach
| Study group | Role | What they receive |
|---|---|---|
| Standard titanium miniplate- single non compression miniplate | Active comparator | fixation will be perform by A single non compression miniplate with 4-hole 2-mm using 2-mm monocortical screws at superior border of the mandible according to ideal lines of osteosynthesis. Receives: Device: 3D titanium miniplate; Device: Standard titanium miniplate- single non compression miniplate |
| three dimensional titanium miniplate | Experimental | 3D curved strut miniplate* (Universal Mandible System, Stryker-Lei binger, Freiburg, Germany) , installed and stabilized with monocortical screws. The 3D plate will be place in such a way that a horizontal bar is perpendicular and a vertical bar is parallel to the fracture line. Receives: Device: 3D titanium miniplate; Device: Standard titanium miniplate- single non compression miniplate |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
- Wound dehiscence (binary outcome) by Clinical examination
- mal /un union (binary outcome) by Clinical examination
- Evaluation of Occlusion (binary outcome) (Only after 3 months of fracture treatment) by using the treatment scoring system35 Surgeon's evaluation
- 5 points: occlusion altered bilaterally. Reoperation required.
- 3 points: occlusion altered on one side: Reoperation required
- 1 point: occlusion altered on one side. The other side has to be adjusted.
- 3 points: occlusion adequate on both sides but not the same as before injury.
- 5 points: occlusion the same as before injury.
Measured: 6 monuths
Secondary outcomes (1)
Radiographic follow-up
The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing by using digora software.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Displaced Mandibular Angle 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Thamar University
- Responsible party
- Principal investigator, ESSAM ALMORAISSI, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939015
- Sponsor's protocol ID
- 201301
- Other IDs
- OMFS201301
- Acronym
- RCTs
- Status last verified
- Dec 2013
- First submitted
- 22 Aug 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Al-Moraissi EA, Mounair RM, El-Sharkawy TM, El-Ghareeb TI. Comparison between three-dimensional and standard miniplates in the management of mandibular angle fractures: a prospective, randomized, double-blind, controlled clinical study. Int J Oral Maxillofac Surg. 2015 Mar;44(3):316-21. doi: 10.1016/j.ijom.2014.10.012. Epub 2014 Nov 15.
PubMed 25457871
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Vs Standard Miniplate in Fixation of the MAFs
- ClinicalTrials.gov ID
- NCT01939015
- Acronym / sponsor ID
- RCTs / 201301
- Conditions
- Displaced Mandibular Angle Fracture
- Keywords
- 3D miniplate, angle mandibular fracture, champy technique, internal rigid fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Thamar University
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Sep 2013 (estimated)
- 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 this study is to compare the standard and 3D miniplates fixation in mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain, hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one method over the other.
- Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients returned 7 days after surgery for clinical evaluation . The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing. the complications encountered will be recorded and treated. The clinical evaluations will be performed by 1 surgeon at each institution.
- The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for infection will based on either of the following conditions: 1) purulent discharge from an incision and 2) serosanguineous drainage and a wound culture positive for a known pathogen. All the patients will evaluated postoperatively by a single assessor.
- Statically analysis :
Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤ 0.05 will be considered statistically significant.
Detailed description
- This study will include 20 dentate patients with mandibular angle fracture whom presented for treatment at Department Of Oral and Maxillofacial Surgery, Faculty Of Oral And Dental Medicine, Cairo University.
- The patients after inclusion will be randomly divided into either Group A or Group B. Group A consist of 10 patients underwent open reduction with internal fixation of the angle mandibular fracture with 3D titanium miniplates whereas Group B consist of 10 patients underwent open reduction with internal fixation of the mandibular angle fracture with standard miniplate using a single miniplate technique of Champy's principle of osteosynthesis.
- Inclusion criteria: 1) Age group between 15-40 years. 2) patients with non-infected and non-comminuted mandibular angle fractures 3) surgical treatment provided within 7 days of injury via open reduction and internal fixation (ORIF) by an extra oral approach 4) no use of postsurgical maxillomandibular fixation (MMF) postoperatively 5) a 1-week duration of postsurgical oral antibiotic therapy.
- Exclusion criteria : 1) the fracture was infected at the time of treatment, 2) medical conditions that could possibly have interfered with healing (diabetes, chemotherapy, etc.) or prevented general anesthesia.
- Preoperative Evaluation
Careful extra and intraoral clinical examinations will be perform on all patients. The presence of lacerations, swelling, ecchymosis, occlusal disturbances, or broken, avulsed, or missing teeth will noted, and the mandibular movements, maximal interincisal opening, and nerve function will be recorded. Palpation of the mandible for areas of tenderness, segment mobility, bony crepitus, and tooth mobility will be also perform . Radiographic images (panoramic and posteroanterior) will be taken to evaluate the fracture. Immediately preoperatively, each patient will be given a standard dose of 1.5 g of Unasyn* and 8 mg of Epidron** intravenously.
-Surgical Technique:
After placement of arch bars, the fracture line will be exposed through extraoral a submandibular (Risdon) incision. Only the amount of soft tissue stripping necessary to visualize, reduce, and stabilize the fracture will be performed. Mobile teeth or teeth with apices that will be exposed in the fracture will be removed.
All a fracture site will be identified, reduced, and after obtaining satisfactory occlusion, temporary maxillomandibular fixation will be placed using either Erich's arch bar or Ivy loop eyelet wiring.
Fixation in group A will be achieved using a 3D curved strut miniplate* (Fig 1) , installed and stabilized with monocortical screws. The 3D plate will be place in such a way that a horizontal bar is perpendicular and a vertical bar is parallel to the fracture line. While in group B fixation will be perform by A single non compression miniplate with 4-hole 2-mm using 2-mm monocortical screws.
In both group fixation will be carried out through extraoral submandibular approach and placed in the neutral zone of the mandibular angle (between tension and compression areas).
After fixation of the fracture, intermaxillary fixation will be removed . And the incisions will be close in layers by absorbable suture while the skin closed by 5-0 nylon sutures. No drains will placed. and the occlusion will checked .
-Postsurgical Management:
Antibiotics will be continued through the preoperative period and for 5 to 7 days after surgery. And other medication to control swelling and pain will be administered. Chlorhexidine mouth rinse will be provided for all patient until removal of arch bars. Soft diet will be strongly recommend for 2 weeks then Pasty diet will be gradually regained .
-Postoperative Evaluation :
Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients returned 7 days after surgery for clinical evaluation . The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing. the complications encountered will be recorded by treatment scoring system and treated. The clinical evaluations will be performed by 1 surgeon at each institution.
The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for infection will based on either of the following conditions: 1) purulent discharge from an incision and 2) serosanguineous drainage and a wound culture positive for a known pathogen. All the patients will evaluated postoperatively by a single assessor.
-Statically analysis :
Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤ 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard titanium miniplate- single non compression miniplate | Active comparator | Device: 3D titanium miniplate, Device: Standard titanium miniplate- single non compression miniplatefixation will be perform by A single non compression miniplate with 4-hole 2-mm using 2-mm monocortical screws at superior border of the mandible according to ideal lines of osteosynthesis. |
| three dimensional titanium miniplate | Experimental | Device: 3D titanium miniplate, Device: Standard titanium miniplate- single non compression miniplate3D curved strut miniplate* (Universal Mandible System, Stryker-Lei binger, Freiburg, Germany) , installed and stabilized with monocortical screws. The 3D plate will be place in such a way that a horizontal bar is perpendicular and a vertical bar is parallel to the fracture line. |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (5 listed)
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 titanium miniplateAlso: Universal Mandible System, Stryker-Lei binger, Freiburg, Germanyfor study group by using 3D titanium miniplate under open reduction under general anesthesia with mono cortical screw, while in control group single titanium miniplate at superior border with mono cortical screw according to ideal line of osteosynthesis of champy | Device | Standard titanium miniplate- single non compression miniplate, three dimensional titanium miniplate |
| Standard titanium miniplate- single non compression miniplateAlso: Champy technique (single non compression miniplate)single non compression miniplate placed at superior border with monocortical screws via intraoral approach | Device | Standard titanium miniplate- single non compression miniplate, three dimensional titanium miniplate |
Primary outcome
postoperative complications
Time frame: 6 monuths
1. Wound dehiscence (binary outcome) by Clinical examination 2. mal /un union (binary outcome) by Clinical examination 3. Evaluation of Occlusion (binary outcome) (Only after 3 months of fracture treatment) by using the treatment scoring system35 Surgeon's evaluation * 5 points: occlusion altered bilaterally. Reoperation required. * 3 points: occlusion altered on one side: Reoperation required * 1 point: occlusion altered on one side. The other side has to be adjusted. * 3 points: occlusion adequate on both sides but not the same as before injury. * 5 points: occlusion the same as before injury.
1 secondary outcome
Radiographic follow-up
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Derived from this study: PubMed 25457871Al-Moraissi EA, Mounair RM, El-Sharkawy TM, El-Ghareeb TI. Comparison between three-dimensional and standard miniplates in the management of mandibular angle fractures: a prospective, randomized, double-blind, controlled clinical study. Int J Oral Maxillofac Surg. 2015 Mar;44(3):316-21. doi: 10.1016/j.ijom.2014.10.012. Epub 2014 Nov 15.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D titanium miniplate and Standard titanium miniplate- single non compression miniplate in people with Displaced Mandibular Angle Fracture, 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 5 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: finished, as of the sponsor's last update on 30 Dec 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 6 monuths). 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 NCT01939015, which also lists 1 linked publication.
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 30 Dec 2013.