Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Bone Marrow Aspirate Concentrate in the Treatment of Mandibular Cystic Defects (Randomized Clinical Trial)

Conditions
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Mandible Cyst

Intervention / Treatment
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* Other: Enucleation and filling by Bone marrow aspirate
* Other: Conventional enucleation only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from mandibular cystic defect. Cystic defect width of 4-8 cm that requires removal under general anesthesia. Exclusion Criteria: Medically compromised patients contradicting operation. Previously enucleated lesions. Previous surgery, tumor, infection to the pelvis affecting the anterior iliac crest. Infected Cysts

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br> | Other: Enucleation and filling by Bone marrow aspirate<br>* 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.<br>|
| Active Comparator: Control group<br> | Other: Conventional enucleation only<br>* patients were treated conventionally by enucleation and plain collagen sponge only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | at baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in wound dehiscence | any signs of wound dehiscence were observed | 1st day, 1 week, 4 weeks, 6 weeks |