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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05658900
Enrollment
20
Registered
2022-12-21
Start date
2022-05-19
Completion date
2023-03-09
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw Cysts

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.

Interventions

OTHEREnucleation with albumin PRF

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.

OTHEREnucleation without albumin PRF

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.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain scoreUp to 1 weekIt 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 healingup to 2 weeksit 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 volumeat baseline and 6 monthsit will be assessed using CBCT

Countries

Egypt

Contacts

Primary ContactMohamed M Shokry, BDS
m_magdy_shokry@hotmail.com01065734994

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026