Jaw CystsNCT05658900
Volumetric Analysis of Bone Following Jaw Cysts Enucleation With and Without Alb-PRF
A study testing Enucleation with albumin PRF and Enucleation without albumin PRF in people with Jaw Cysts, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Cyst is the main cause for longstanding swelling in the mandible or the maxilla, its enlargement usually results in resorption and weakening of bone. Thus the treatment of the cysts is essential to preserve the bone and the adjacent vital structures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaw Cysts
- What is being tested?
- Enucleation with albumin PRF and Enucleation without albumin PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2022to 9 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from jaw cystic cavity volume greater than 1cm3
- Patients with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 6 months.
- Cystic lesion that requires removal under local or general anaesthesia.
Who cannot join
- Medically compromised patients contradicting operation.
- Patients with history of chemotherapy or radiotherapy.
- Patients with low level of platelet count.
- Patients with anticoagulant therapy.
- Patients who are unable to attend follow up appointments
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
Faculty of Dentistry, (203) 4868308
Mohamed M Shokry, BDS
About this study
Official title: Three-dimensional Volumetric Analysis of Bone Regeneration Following Jaw Cysts Enucleation With and Without Autologous Albumin Gel-platelet-rich Fibrin Mixture (A Randomized Controlled Clinical Trial)
Cyst is the main cause for longstanding swelling in the mandible or the maxilla, its enlargement usually results in resorption and weakening of bone. Thus the treatment of the cysts is essential to preserve the bone and the adjacent vital structures. Healing of the bone defect and its surrounding soft tissues is a critical issue that needs concerns. Although the Platelet rich fibrin has promising effects in wound healing, it can resorb during 10-14 days. Thus a new autologous platelet concentrate is introduced by Kawasi et al that can remain stable for 4-6 months called albumin PRF.
- Conditions
- Jaw Cysts
- Being tested
- Enucleation with albumin PRF, Enucleation without albumin PRF
- Medical subject headings
- Jaw Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enucleation with albumin PRFOther
The protocol that will be used in the preparation of albumin PRF
- A sample of venous blood, at ten milliliters, at least will be drawn from the patient in a sterile centrifuge tube.
- The venous blood sample will be centrifuged at 700 g for 8 minutes.
- Betadine: Povidone-iodine, 7.5% (0.75% available iodine), Purdue Products L.P
- The platelet-poor plasma layer will be taken and heated at uniform temperature 75 celsius for 10 minutes in a thermostatic water bath incubator to denature albumin protein forming albumin gel.
- Once the albumin gel is cooled, to room temperature for 10 minutes, it will be mixed with the buffy coat layer of PRF using 3 way stop cock and 2 plastic syringes with Luer lock to obtain albumin PRF then leave it in the dappen dish for 5 minutes.
Enucleation without albumin PRFOther
The full-thickness mucoperiosteal flap will be performed using blade no. 15 and Bard- Parker handles extending one tooth anterior and one tooth posterior to the cystic cavity.
The mucoperiosteal flap will be reflected using the periosteal elevator to expose the bone.
Removal of the overlying bone to expose the cystic lesion. Enucleation of the cyst.
| Study group | Role | What they receive |
|---|---|---|
| Enucleation with albumin PRF | Experimental | Not described Receives: Other: Enucleation with albumin PRF |
| Enucleation without albumin PRF | Active comparator | Not described Receives: Other: Enucleation without albumin PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score
It will be assessed on 3rd and 7th day through a 10-point Visual Analogue Scale (VAS)(25) (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Measured: Up to 1 week
Change in soft tissue healing
it will be used using Landry index Healing Index 1: Very poor (has two or more of the following) Healing Index 2: Poor Healing Index 3: Good Healing Index 4: Very good Healing Index 5: Excellent
Measured: up to 2 weeks
change in bone volume
it will be assessed using CBCT
Measured: at baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start19 May 2022
- Primary completion9 Mar 2023 (estimated)
- Study completion9 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaw CystsStudies 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
- 20 participants (estimated)
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
- NCT05658900
- Sponsor's protocol ID
- Cysts_2022
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shokry MMEM, Melek LNF, Amer TA. Three-dimensional volumetric analysis of bone regeneration following jaw cyst enucleation with and without an autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF): a randomized controlled clinical trial. BMC Oral Health. 2025 May 8;25(1):693. doi: 10.1186/s12903-025-06027-w.
PubMed 40340767
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Volumetric Analysis of Bone Regeneration Following Jaw Cysts Enucleation With and Without Autologous Albumin Gel-platelet-rich Fibrin Mixture (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05658900
- Acronym / sponsor ID
- Cysts_2022
- Conditions
- Jaw Cysts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 9 Mar 2023 (estimated)
- Study completion
- 9 Mar 2023 (estimated)
- First posted
- 21 Dec 2022 (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.
Cyst is the main cause for longstanding swelling in the mandible or the maxilla, its enlargement usually results in resorption and weakening of bone. Thus the treatment of the cysts is essential to preserve the bone and the adjacent vital structures. Healing of the bone defect and its surrounding soft tissues is a critical issue that needs concerns. Although the Platelet rich fibrin has promising effects in wound healing, it can resorb during 10-14 days. Thus a new autologous platelet concentrate is introduced by Kawasi et al that can remain stable for 4-6 months called albumin PRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enucleation with albumin PRF | Experimental | Other: Enucleation with albumin PRF |
| Enucleation without albumin PRF | Active comparator | Other: Enucleation without albumin PRF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffering from jaw cystic cavity volume greater than 1cm3
- Patients with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 6 months.
- Cystic lesion that requires removal under local or general anaesthesia.
Key exclusion criteria (5 listed)
- Medically compromised patients contradicting operation.
- Patients with history of chemotherapy or radiotherapy.
- Patients with low level of platelet count.
- Patients with anticoagulant therapy.
- Patients who are unable to attend follow up appointments
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 with albumin PRFThe protocol that will be used in the preparation of albumin PRF 1. A sample of venous blood, at ten milliliters, at least will be drawn from the patient in a sterile centrifuge tube. 2. The venous blood sample will be centrifuged at 700 g for 8 minutes. * Betadine: Povidone-iodine, 7.5% (0.75% available iodine), Purdue Products L.P 3. The platelet-poor plasma layer will be taken and heated at uniform temperature 75 celsius for 10 minutes in a thermostatic water bath incubator to denature albumin protein forming albumin gel. 4. Once the albumin gel is cooled, to room temperature for 10 minutes, it will be mixed with the buffy coat layer of PRF using 3 way stop cock and 2 plastic syringes with Luer lock to obtain albumin PRF then leave it in the dappen dish for 5 minutes. | Other | Enucleation with albumin PRF |
| Enucleation without albumin PRFThe full-thickness mucoperiosteal flap will be performed using blade no. 15 and Bard- Parker handles extending one tooth anterior and one tooth posterior to the cystic cavity. The mucoperiosteal flap will be reflected using the periosteal elevator to expose the bone. Removal of the overlying bone to expose the cystic lesion. Enucleation of the cyst. | Other | Enucleation without albumin PRF |
Primary outcome
Change in pain score
Time frame: Up to 1 week
It will be assessed on 3rd and 7th day through a 10-point Visual Analogue Scale (VAS)(25) (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Change in soft tissue healing
Time frame: up to 2 weeks
it will be used using Landry index Healing Index 1: Very poor (has two or more of the following) Healing Index 2: Poor Healing Index 3: Good Healing Index 4: Very good Healing Index 5: Excellent
change in bone volume
Time frame: at baseline and 6 months
it will be assessed using CBCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 40340767Shokry MMEM, Melek LNF, Amer TA. Three-dimensional volumetric analysis of bone regeneration following jaw cyst enucleation with and without an autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF): a randomized controlled clinical trial. BMC Oral Health. 2025 May 8;25(1):693. doi: 10.1186/s12903-025-06027-w.
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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.
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 with albumin PRF and Enucleation without albumin PRF in people with Jaw Cysts, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M Shokry, BDS (01065734994, m_magdy_shokry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score (time frame: Up to 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05658900, which also lists 1 linked publication.
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 21 Dec 2022.