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The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.
The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used:
Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subtarsal approach | Active Comparator |
| |
| conventional transconjunctival approach | Active Comparator |
| |
| transconjunctival approach with Y- modification | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subtarsal approach | Procedure | surgical approach |
| |
| Measure | Description | Time Frame |
|---|---|---|
| accessibility to the fracture site | Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No | intraoperative |
| esthetic appearance and scarring | Postoperative scarring was recorded as noticeable or unnoticeable | 6 weeks postoperative |
| radiographic verification of adequacy of fracture reduction | computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No | immediate postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| The duration for exposure of the fracture site | The duration from performing the incision till the field exposure calculated in minutes | intraoperative |
| postoperative pain | Pain was evaluated at 24 hours and at 1 week according to a 10-point Visual Analogue Scale (VAS), (0-1=none,2-4=mild,5-7=moderate,8-10=severe). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | 21526 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37542217 | Derived | Melek LN, Noureldin MG. Zygomaticomaxillary complex fractures: finding the least complicated surgical approach (A Randomized Clinical Trial). BMC Oral Health. 2023 Aug 4;23(1):539. doi: 10.1186/s12903-023-03249-8. |
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| ID | Term |
|---|---|
| D015051 | Zygomatic Fractures |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| conventional transconjunctival approach |
| Procedure |
surgical approach |
|
| transconjunctival approach with Y- modification | Procedure | surgical approach |
|
| at 24 hours and 1 week |
| sensory nerve function | Subjective assessment of the infraorbital nerve sensation by patient questioning about any alteration in sensation at 3 months postoperatively. Objective assessment by dental probe pressure to assess sensory changes along the distribution of the infraorbital nerve with contralateral side comparison | 3 months postoperative |
| D009422 |
| Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |