Displaced Mandibular Angle Fracture Clinical Trial
— RCTsOfficial title:
3D Vs Standard Miniplate in Fixation of the MAFs
Verified date | December 2013 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt : Faculty of Oral and Dental Medicine |
Study type | Interventional |
- 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.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 17 Years to 45 Years |
Eligibility |
- Inclusion Criteria: - Adults dentate patients (>17 years old) with displaced an angle mandibular fracture - non infected non comminuted angle mandibular fracture - Exclusion Criteria: - infected angle mandibular fracture - atrophied mandibular fracture - angle fracture with subcondylar fracture - patients under 17 year - gun shout injury associated fracture |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Department of Oral and Maxillofacial SurgeryFaculty of Oral and Dental Medicine | Cairo | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Faculty of dentistry,Dhamar university,Yemen |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | mouth opening | BY USING BOELY GAUGE IN MILLIMTER | 7 days | No |
Primary | 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. |
6 monuths | Yes |
Secondary | 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. | 6 months | No |