Volumetric Analysis of Bone Following Jaw Cysts Enucleation With and Without Alb-PRF

Not Applicable

Recruiting

• Conditions: Jaw Cysts
• Interventions: Other: Enucleation without albumin PRF; Other: Enucleation with albumin PRF

• Registration Number: NCT05658900
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-19
• Status Verified: 2022-12
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-21
• Last Update Posted: 2022-12-21
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enucleation without albumin PRF	Enucleation without albumin PRF	-
Enucleation with albumin PRF	Enucleation with albumin PRF	-

Primary Outcome Measures

Name	Time	Method
Change in soft tissue healing	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	at baseline and 6 months	it will be assessed using CBCT
Change in pain score	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)

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Azarita, Egypt