Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects

NCT ID: NCT05748756

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2022-07-17

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.

Conditions

Mandible Cyst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group

Group Type: EXPERIMENTAL

Enucleation and filling by Bone marrow aspirate

Intervention Type: OTHER

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.

Control group

Group Type: ACTIVE_COMPARATOR

Conventional enucleation only

Intervention Type: OTHER

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

Interventions

Enucleation 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.

Intervention Type: OTHER

Conventional enucleation only

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, Egypt

Countries

Egypt

Other Identifiers

BM_22

Identifier Type: -

Identifier Source: org_study_id