Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects

Not Applicable

Completed

• Conditions: Mandible Cyst
• Interventions: Other: Enucleation and filling by Bone marrow aspirate; Other: Conventional enucleation only

• Registration Number: NCT05748756
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-19
• Primary Completion: 2022-07-13
• Study Completion: 2022-07-17
• Status Verified: 2023-02
• Study First Submitted: 2023-02-19
• Study First Submitted QC: 2023-02-19
• Last Update Submitted: 2023-02-19
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Enucleation and filling by Bone marrow aspirate	-
Control group	Conventional enucleation only	-

Primary Outcome Measures

Name	Time	Method
Change in pain scores	1st day, 1 week, 4 weeks, 6 weeks	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)
Change in bone density	at baseline, 3 months, 6 months	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.

Secondary Outcome Measures

Name	Time	Method
change in wound dehiscence	1st day, 1 week, 4 weeks, 6 weeks	any signs of wound dehiscence were observed

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Azarita, Egypt