Mandible CystNCT05748756
Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects
A study testing Enucleation and filling by Bone marrow aspirate and Conventional enucleation only in people with Mandible Cyst, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mandible Cyst
- What is being tested?
- Enucleation and filling by Bone marrow aspirate and Conventional enucleation only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2022to 17 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from mandibular cystic defect.
- Cystic defect width of 4-8 cm that requires removal under general anesthesia.
Who cannot join
- Medically compromised patients contradicting operation.
- Previously enucleated lesions.
- Previous surgery, tumor, infection to the pelvis affecting the anterior iliac crest.
- Infected Cysts
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: The Effect of Bone Marrow Aspirate Concentrate in the Treatment of Mandibular Cystic Defects (Randomized Clinical Trial)
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
- Being tested
- Enucleation and filling by Bone marrow aspirate, Conventional enucleation only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enucleation and filling by Bone marrow aspirateOther
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 onlyOther
patients were treated conventionally by enucleation and plain collagen sponge only.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: Enucleation and filling by Bone marrow aspirate |
| Control group | Active comparator | Not described Receives: Other: Conventional enucleation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: at baseline, 3 months, 6 months
Secondary outcomes (1)
change in wound dehiscence
any signs of wound dehiscence were observed
Measured: 1st day, 1 week, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start19 Jan 2022
- Primary completion13 Jul 2022
- Study completion17 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748756
- Sponsor's protocol ID
- BM_22
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bone Marrow Aspirate Concentrate in the Treatment of Mandibular Cystic Defects (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05748756
- Acronym / sponsor ID
- BM_22
- Conditions
- Mandible Cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 17 Jul 2022 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Enucleation and filling by Bone marrow aspirate |
| Control group | Active comparator | Other: Conventional enucleation only |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients suffering from mandibular cystic defect.
- Cystic defect width of 4-8 cm that requires removal under general anesthesia.
Key exclusion criteria (4 listed)
- Medically compromised patients contradicting operation.
- Previously enucleated lesions.
- Previous surgery, tumor, infection to the pelvis affecting the anterior iliac crest.
- Infected Cysts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enucleation and filling by Bone marrow aspirateThe 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. | Other | Test group |
| Conventional enucleation onlypatients were treated conventionally by enucleation and plain collagen sponge only. | Other | Control group |
Primary outcome
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)
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.
1 secondary outcome
change in wound dehiscence
Time frame: 1st day, 1 week, 4 weeks, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
Related trials for Mandible Cyst
Active, not recruiting
Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
Impact Molar, Mandible Cyst
Recruiting
Artificial Intelligence-Based Assessment of Endosseous Lesions
Maxillary Cyst, Mandibular Cyst
Recruiting
Treatment of Mandibular Bone Cyst by Navigation and Endoscopy
Jaw Cysts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enucleation and filling by Bone marrow aspirate and Conventional enucleation only in people with Mandible Cyst, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: 1st day, 1 week, 4 weeks, 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.