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A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional Erich's arch bar | Active Comparator | • Patients will receive conventional Erich's arch bar |
|
| Screw Retained Arch Bar | Experimental | patients will receive modified screw retained arch bar. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| screw retained arch bar | Procedure | maxillomandibular fixation with bone screwed arch bar |
|
| Measure | Description | Time Frame |
|---|---|---|
| duration of surgical procedure in minutes | Duration between the starting of fixation and complete fixation of fracture | intraoperative |
| maxillomandibular fixation stability in nominal scale(stable-unstable) | stability after fixation | immediately postoperative |
| maxillomandibular fixation stability in nominal scale(stable-unstable) | stability after fixation | 4-6 weeks |
| oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S) | 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. | immediately postoperative |
| oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S) | 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. | 4-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| number of iatrogenic injuries | iatrogenic injuries to teeth and gingiva | intraoperative |
| number of needle and wire stick injuries | injuries to the surgeon and the assistants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura university | Al Mansurah | 35516 | Egypt |
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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| conventional Erich's Arch Bar | Procedure | maxillomandibular fixation with conventional arch bar fixed to the teeth |
|
| intraoperative |
| pain assessment using numeric rating scale (NRS) | 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"). | immediately postoperative |
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |