Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects

NCT05748756 | Completed

• 1 other identifier: BM_22
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• change in wound dehiscence

  1st day, 1 week, 4 weeks, 6 weeks

Study Arms (2)

Test group

EXPERIMENTAL

Other: Enucleation and filling by Bone marrow aspirate

Control group

ACTIVE COMPARATOR

Other: Conventional enucleation only

Interventions

Enucleation and filling by Bone marrow aspirate 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.

Test group

Conventional enucleation only OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients suffering from mandibular cystic defect.
• Cystic defect width of 4-8 cm that requires removal under general anesthesia.

You may not qualify if:

• Medically compromised patients contradicting operation.
• Previously enucleated lesions.
• Previous surgery, tumor, infection to the pelvis affecting the anterior iliac crest.
• Infected Cysts

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 1, 2023
• Study Start: January 19, 2022
• Primary Completion: July 13, 2022
• Study Completion: July 17, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

EG (1)