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Two groups of patients with maxillary defects resulted from enucleation of intra-bony cystic lesions the 1st group will be subjected to guided bone regeneration while the second group will be subjected to spontaneous bone regeneration.
Two groups of patients with maxillary cystic lesions indicated for enucleation. One will be subjected to guided bone regeneration while the other will be subjected to spontaneous bone regeneration.
General pre-operative procedures:
intraoperative procedure: (both groups)
Intra-operative procedures - continued in first Group (GBR group) The intra-bony defect will be filled with Deproteinized Bovine Bone. In Both groups: Titanium mesh will be tailored with 3mm overlap at the edges to cover the bone window completely and fixed to the bone using mono-cortical titanium screws.
This is followed by Primary closure using 4-0 vicryl sutures that will be removed 10 days postoperatively.
Postoperative medications:
For both groups, postoperative antibiotic course of amoxicillin+ clavulanic acid 1 g tab (Augmentin) will be prescribed for one week and isobutylphenylpropionic acid 600 mg tab (Brufen) twice daily for one week. One shot of dexamethasone 8 mg vial will be administered intramuscularly immediately after the surgery together with ketorolac tromethamine 30 mg .
Postoperative care and instructions:
Radiographic assessment will be achieved by CBCT scan preoperatively, immediately postoperative ,and 6 months postoperatively to evaluate the change in the bone density . A total of three scans will be taken for each patient.
In the second group, the amount and percentage of bone gain will be measured based on the CBCT scans .
in the 6 months after the surgery ,titanium mesh and the screws will be removed and core biopsy will be taken for histological assessment.
dental implant/s will be placed in cases indicated for implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spontaneous bone regeneration | Active Comparator | after cyst enucleation, the intra-bony defect will be covered by Titanium mesh that is fixed by mono-cortical titanium screws. |
|
| guided bone regeneration | Experimental | cyst enucleation will be followed by filling the intra-bony defect with Deproteinized Bovine Bone. -Titanium mesh will cover the bone window completely and will be fixed to the bone using mono-cortical titanium screws. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spontaneous bone regeneration | Procedure | stage 1 surgery:
This will be followed by: Primary closure using 4-0 vicryl sutures that will be removed 10 days postoperatively. stage 2 surgery(after 6 months):
|
| Measure | Description | Time Frame |
|---|---|---|
| The amount of change in the Bone density | Measuring the amount of change in the bone density using cone beam computed tomography in hounsfield unit | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of bone area | Measuring the percentage of bone area using Histomorphometric analysis of decalcified bone sections with hematoxylin and eosin(H&E) stain using image analyzer computer system. | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of mature bone | Measuring the percentage of mature bone using Histomorphometric analysis of decalcified bone sections with Masson's trichrome stain using image analyzer computer system. | 6 months postoperatively |
| amount and percentage of bone gain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed A Abdelrasoul, PhD | faculty of oral and dental medicine, Cairo university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of oral and dental medicine, Cairo university | Cairo | Giza Governorate | 12613 | Egypt |
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| Label | URL |
|---|---|
| Radiographic bone volume alteration after jaw cyst enucleation with or without simultaneous bone grafts: A prospective randomized study | View source |
| Review Int J Oral Sci . 2020 Dec 30;12(1):37. doi: 10.1038/s41368-020-00107-z. Titanium mesh for bone augmentation in oral implantology: current application and progress | View source |
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This trial is considered a randomized single blind clinical trial due to the following:
|
| guided bone regeneration | Procedure | stage 1 surgery after cyst enucleation and extraction of the non-restorable teeth related to the lesion, The intra-bony defect will be filled with Deproteinized Bovine Bone. -Titanium mesh will be tailored with 3mm overlap at the edges to cover the bone window completely and fixed to the bone using mono-cortical titanium screws. This will be followed by Primary closure using 4-0 vicryl sutures that will be removed 10 days postoperatively. stage 2 surgery(6 months later) :
|
|
Measuring the amount of bone gain using cone beam computed tomography in millimeters and the percentage in % (in the second group)
| 6 months |
| Jaw cysts - filling or no filling after enucleation? A review | View source |
| Bone Grafts and Substitutes in Dentistry: A Review of Current Trends and Developments | View source |
| Barrier Membranes for Guided Bone Regeneration (GBR): A Focus on Recent Advances in Collagen Membranes | View source |