Volumetric Analysis of Bone Following Jaw Cysts Enucleation With and Without Alb-PRF
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)
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2022
CompletedFirst Submitted
Initial submission to the registry
December 12, 2022
CompletedFirst Posted
Study publicly available on registry
December 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2023
CompletedDecember 21, 2022
December 1, 2022
10 months
December 12, 2022
December 12, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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)
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
up to 2 weeks
change in bone volume
it will be assessed using CBCT
at baseline and 6 months
Study Arms (2)
Enucleation with albumin PRF
EXPERIMENTALEnucleation without albumin PRF
ACTIVE COMPARATORInterventions
The 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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203, Egypt
Related Publications (1)
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.
PMID: 40340767DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
December 12, 2022
First Posted
December 21, 2022
Study Start
May 19, 2022
Primary Completion
March 9, 2023
Study Completion
March 9, 2023
Last Updated
December 21, 2022
Record last verified: 2022-12