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P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch.
this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRF/ BCP | Experimental | Biphasic calcium phosphate (BCP)"bioceramic bone substitute combined with platelet rich fibrin PRF |
|
| autogenous bone graft | Active Comparator | Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRF/ BCP | Other | Platelet rich fibrin combined with biphasic calcium phosphate(experimental group) |
|
| Measure | Description | Time Frame |
|---|---|---|
| bone height | the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge. | six months postoperative. |
| Measure | Description | Time Frame |
|---|---|---|
| bone volume | V= (A1xT) + ( A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices | six months postoperative. |
| operation duration | It is the time elapsed between using the scalable for incision and the last stitch. It will be measured by watch in hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | 3311 | Egypt |
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| ID | Term |
|---|---|
| D056690 | Prolactin-Releasing Hormone |
| ID | Term |
|---|---|
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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Eighteen patients will be divided into two equal groups. Each group comprises nine patients.
Group A: Platelet-rich Fibrin combined with Biphasic Calcium Phosphate.(interventional group) Group B: autogenous bone graft (controlled group)
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| Autogenous bone graft | Other | Bone obtained from the same individual who receiving the graft |
|
| within 4 hours ( the actual number of hours will be determined intra-operative ) |
| hospital stay | Number of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge | within 7 days |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |