faculty of oral and dental medicine, Cairo university
Cairo, Giza Governorate, 12613, Egypt
NCT Number: NCT06749158
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.
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Notify Me20 year–50 year
All sexes
Interventional
Not applicable
Cairo, Giza Governorate, 12613, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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):
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) :
Time frame: 6 months postoperatively
Measuring the amount of change in the bone density using cone beam computed tomography in hounsfield unit
Time frame: 6 months postoperatively
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.
Time frame: 6 months postoperatively
Measuring the percentage of mature bone using Histomorphometric analysis of decalcified bone sections with Masson's trichrome stain using image analyzer computer system.
Time frame: 6 months
Measuring the amount of bone gain using cone beam computed tomography in millimeters and the percentage in % (in the second group)
Cairo University
Other
Radiographic and Histological Assessment of Guided Bone Regeneration Using Deproteinized Bovine Bone Compared to Spontaneous Bone Regeneration of Maxillary Defects , Resulted From Enucleation of Intra-bony Cystic Lesions : Randomized Control Clinical Trial
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