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Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence?
The primary objective is to assess and evaluate the improvement of wound healing (edema at 5th day post operatively) as a primary outcome, and secondary objective is to assess and evaluate the wound closure and the decreasing of the occurrence of the oronasal fistula as a secondary outcome among children with cleft palate, using plasma rich growth factor between nasal mucosa and palatal mucosa
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plasma rich growth factor (PRGF) (intervention or study group) | Active Comparator | plasma rich growth factor (PRGF) intervention or study group Has Surgical procedures "von Langenbeck technique " to repair cleft palate and placing plasma rich growth factors between nasal and palatal tissue then primary closure intraoperatively, then patient will come for follow up visit after surgery, 1st day, 3rd, 5th day and come for follow up visits at 1 week, 1 month and 3 months postoperative |
|
| placebo (control group) | Placebo Comparator | placebo (control group) Has Surgical procedures "von Langenbeck technique " to repair cleft palate primary closure, then patient will come for follow up visit after surgery, 1st day, 3rd, 5th day and come for follow up visits at 1 week, 1 month and 3 months postoperative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Rich in Growth Factors (PRGF) | Other | using prgf with closing primary cleft palate - isolated cleft palate Minutes before the surgery, 10-20 ml of venous blood from each patient. -The blood is centrifuged to obtain PRGF. -Fixed between nasal and palatal mucosa |
| Measure | Description | Time Frame |
|---|---|---|
| wound healing assesment (edema at 5th day post operatively) | clinical records, percentage of persistence of edema number of participants with percentage of persisting of edema | first day after surgery, 3rd day, and 5th day |
| Measure | Description | Time Frame |
|---|---|---|
| wound healing assesment | clinical records, counting days for healing as healing by days till closure | 2 years |
| the occurrence of oronasal fistula | clinical records, yes/no Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Manial | Cairo Governorate | Egypt |
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| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.
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Single blinded study. Blinding to the patient will be ensured by masking the instruments during the follow up. The patient will be informed of the steps of the follow up (as mentioned in the consent form) without getting into details of the method of follow up.
| Placebo | Other | primary closing cleft palate-isolated cleft palate |
|
| first day after surgery to end of treatment at 3 months |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |