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Completed

NCT Number: NCT05748756

Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects

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.

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Key information

Conditions

Mandible Cyst

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Conventional enucleation only

Other

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

Primary outcomes

  1. Change in pain scores

    Time frame: 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)

  2. Change in bone density

    Time frame: 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 outcomes

  1. change in wound dehiscence

    Time frame: 1st day, 1 week, 4 weeks, 6 weeks

    any signs of wound dehiscence were observed

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2023
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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