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)

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 Overview

• Status: Recruiting
• Conditions: Jaw Cysts
• Intervention / Treatment: Other: Enucleation with albumin PRF; Other: Enucleation without albumin PRF

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed M Shokry, BDS; Phone Number: 01065734994; Email: m_magdy_shokry@hotmail.com

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Recruiting
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
      • Contact: Faculty of Dentistry; Phone Number: (203) 4868308
      • Principal Investigator: Mohamed M Shokry, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enucleation with albumin PRF	Other: Enucleation with albumin PRF; 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.
Active Comparator: Enucleation without albumin PRF	Other: Enucleation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Anticipated): March 9, 2023
• Study Completion (Anticipated): March 9, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Musculoskeletal Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Jaw Diseases; Bone Cysts; Cysts; Jaw Cysts
• Other Study ID Numbers: Cysts_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No