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patient receiving treatment using the osmed expander will have enough soft tissue coverage securing the bone graft which will be placed in a later stage to close the alveolar cleft.
to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence and will have a higher volume of soft tissue at the stage of bone grafting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osmed self inflating tissue expanders | Experimental | All patients will undergo a two-stage procedure ,second stage under General endotracheal anesthesia. The first stage will be placement of the expanders. The second stage will be 21 days later, with removal of the expanders, palatal revision, and closure of the oronasal fistula |
|
| Iliac bone graft | Experimental | Placement of bone graft without the use of self inflating expanders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osmed self inflating tissue expanders | Device | Osmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No) | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Galal El Behiry, Phd | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university | Giza | Egypt |
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| Iliac bone graft | Other | Bone grafting the cleft without the use of osmed self inflating tissue expander |
|