Mandibular Fractures
Conditions
Brief summary
A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation
Detailed description
2\) Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar.
Interventions
PROCEDUREscrew retained arch bar
maxillomandibular fixation with bone screwed arch bar
PROCEDUREconventional Erich's Arch Bar
maxillomandibular fixation with conventional arch bar fixed to the teeth
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. The patients age ranges from 18 to 50 years. 2. Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction. 3. Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.
Exclusion criteria
* 1\) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of surgical procedure in minutes | intraoperative | Duration between the starting of fixation and complete fixation of fracture |
| maxillomandibular fixation stability in nominal scale(stable-unstable) | immediately postoperative | stability after fixation |
| oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S) | immediately postoperative | the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of iatrogenic injuries | intraoperative | iatrogenic injuries to teeth and gingiva |
| number of needle and wire stick injuries | intraoperative | injuries to the surgeon and the assistants. |
| pain assessment using numeric rating scale (NRS) | immediately postoperative | participants rated their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). |
Countries
Egypt
Outcome results
None listed