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Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05748756
Enrollment
16
Registered
2023-03-01
Start date
2022-01-19
Completion date
2022-07-17
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandible Cyst

Brief summary

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.

Interventions

OTHEREnucleation and filling by Bone marrow aspirate

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.

OTHERConventional enucleation only

patients were treated conventionally by enucleation and plain collagen sponge only.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain scores1st day, 1 week, 4 weeks, 6 weekspain 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)
Change in bone densityat baseline, 3 months, 6 monthsAn 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.

Secondary

MeasureTime frameDescription
change in wound dehiscence1st day, 1 week, 4 weeks, 6 weeksany signs of wound dehiscence were observed

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026