An interventional study of Enucleation and filling by Bone marrow aspirate and Conventional enucleation only in Mandible Cyst, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment
Mandibular cystic defect healing is a complex process. Various methods have been developed to shorten the bone regeneration time and improve its quality. Autogenous grafting is the gold standard for filling cystic defects due to the osteogenesis property provided by the viable cells but is related to donor site morbidity. Allografts and Xenografts are used for the same purpose. However, the increased cost is their main disadvantage. Bone marrow aspirate concentrate is now used to enhance the healing and regeneration process in many areas of the body with no morbidity and low cost.
Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Other: Enucleation and filling by Bone marrow aspirate
Other: Conventional enucleation only
The iliac crest is palpated along its widest part forming the iliac tubercle ( 5-6 cm posterior to the anterior superior iliac spine), then a 5 mm incision is made 3-4 cm posterior to the ASIS directly on the crest. The needle is advanced between the outer and inner plates of the ileum for a 4-6 cm into the cancellous bone and 10 ml of bone marrow is aspirated. Bone marrow aspirate is processed by a dual centrifugation technique.
patients were treated conventionally by enucleation and plain collagen sponge only.
Change in pain scores
pain was assessed through a 10-point Visual Analogue Scale (VAS) the scores are categorizied as follows: (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Time frame: 1st day, 1 week, 4 weeks, 6 weeks
Change in bone density
An immediate postoperative CBCT was be obtained, followed by another one taken after 3 and 6 months postoperatively. The Region of Interest (ROI) feature was used to estimate the mean bone density in the immediate and 6 months scans. The mean bone density in the 6 months CBCT-scan was compared with the immediate postoperative and the preoperative scans and the mean difference between the scans was calculated.
Time frame: at baseline, 3 months, 6 months
change in wound dehiscence
any signs of wound dehiscence were observed
Time frame: 1st day, 1 week, 4 weeks, 6 weeks
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Hams Hamed Abdelrahman