Volumetric Analysis of Bone Following Jaw Cysts Enucleation With and Without Alb-PRF
Primary Purpose
Jaw Cysts
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Enucleation with albumin PRF
Enucleation without albumin PRF
Sponsored by
About this trial
This is an interventional treatment trial for Jaw Cysts
Eligibility Criteria
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
Sites / Locations
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, EgyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enucleation with albumin PRF
Enucleation without albumin PRF
Arm Description
Outcomes
Primary Outcome Measures
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)
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
change in bone volume
it will be assessed using CBCT
Secondary Outcome Measures
Full Information
NCT ID
NCT05658900
First Posted
December 12, 2022
Last Updated
December 12, 2022
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT05658900
Brief Title
Volumetric Analysis of Bone Following Jaw Cysts Enucleation With and Without Alb-PRF
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
March 9, 2023 (Anticipated)
Study Completion Date
March 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw Cysts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enucleation with albumin PRF
Arm Type
Experimental
Arm Title
Enucleation without albumin PRF
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Enucleation with albumin PRF
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enucleation without albumin PRF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain score
Description
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)
Time Frame
Up to 1 week
Title
Change in soft tissue healing
Description
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
Time Frame
up to 2 weeks
Title
change in bone volume
Description
it will be assessed using CBCT
Time Frame
at baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M Shokry, BDS
Phone
01065734994
Email
m_magdy_shokry@hotmail.com
Facility Information:
Facility Name
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
City
Alexandria
State/Province
Azarita
ZIP/Postal Code
00203
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faculty of Dentistry
Phone
(203) 4868308
First Name & Middle Initial & Last Name & Degree
Mohamed M Shokry, BDS
12. IPD Sharing Statement
Learn more about this trial
Volumetric Analysis of Bone Following Jaw Cysts Enucleation With and Without Alb-PRF
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