Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03399760
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2018-01-08
Brief Title:
Efficacy of Injectable Platelet Rich Fibrin i-PRF in Enhancing Bone Quality
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Evaluation the Dento-alveolar Changes After Platelet Rich Fibrin i-PRF Injection During Upper Canine Retraction Using Cone-beam Computed Tomography CBCT
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into two groups and will randomly assigned to one side of the maxillary arch at the first premolar region and the other side served as the control Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side Soldered transpalatal arch will be used as an anchor unit The dento-alveolar changes will be assessed immediately before retraction and after 6 months using CBCT
Detailed Description:
Extraction is a procedure that is currently performed in orthodontics either in the context of early treatment or for adolescents with severe crowding or protrusionoverjet The consequences of this simple procedure may show up many mucosal and osseous complications such as bone resorption with collapse of the alveolar process a gingival cleft or gingival recession in the area surrounding the extraction site Besides the potential esthetic repercussions these periodontal defects also give rise to a clinical problem with achieving some orthodontic movements such as complete closure of the space or uprighting a root
A systematic review evaluating alveolar bone dimension changes of extraction sockets showed a range of width reduction of 26-46mm Two-thirds of the loss occurred in the first 3 months the remodeling of alveolar bone in the extraction site always decreases ridge volume and deforms the ridge configuration which impairs orthodontic movement of the tooth posteriorly
Endogenously produced biologicals have been tested based on their roles in the turnover of alveolar bone in response to orthodontic tooth movement as well as during wound healing
From here it has been thought about using a method to enhance bone quality after extraction The platelet rich fibrin PRF has the ability to enhance tissue regeneration accelerate wound healing and inducing stem cells differentiation through its growth factors GFs
PRF characteristics in comparison to platelet rich plasma PRP are
1 its preparation is completely natural and there is no need for thrombin addition so there isnt immune reaction
2 it contains stem cells
3 it requires one stage centrifugation
4 PRF has been reported to gradually release autologous growth factors and expressed stronger and more durable effect on the cellular proliferation and differentiation than PRP in vitro This is the first study in the world that will use i-PRF with Orthodontic treatment because of its benefits and easiness of using in dental clinic Study sample that consists of 20 patients Allocation of the sides of intervention PRF injection and control sides is made by computer program Excel
After ensuring of the patients compliance with the terms and conditions of this study the purpose and methods of the study will be explained to the patients using Information Sheet In case of approval to participate the patients asked to sign the Informed Consent
Extra Intra-oral photographs impressions and clinical examination will be made
Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time 20ml of patients blood will be withdrawn and centrifuged 700 rpm within 3 minutes to get 4ml i-PRF PRF will be injected at the area of the extracted first premolar The first point place is in the buccal interventional side supra periosteal injection and the second point place is in the palatal interventional sidesub periosteal injection PRF will be injected twice at the beginning and at the middle of the canine retraction
High resolution CBCT will be taken before the beginning of canine retraction T0 and after 6 months T1
A systematic review evaluating alveolar bone dimension changes of extraction sockets showed a range of width reduction of 26-46mm Two-thirds of the loss occurred in the first 3 months the remodeling of alveolar bone in the extraction site always decreases ridge volume and deforms the ridge configuration which impairs orthodontic movement of the tooth posteriorly
Endogenously produced biologicals have been tested based on their roles in the turnover of alveolar bone in response to orthodontic tooth movement as well as during wound healing
From here it has been thought about using a method to enhance bone quality after extraction The platelet rich fibrin PRF has the ability to enhance tissue regeneration accelerate wound healing and inducing stem cells differentiation through its growth factors GFs
PRF characteristics in comparison to platelet rich plasma PRP are
1 its preparation is completely natural and there is no need for thrombin addition so there isnt immune reaction
2 it contains stem cells
3 it requires one stage centrifugation
4 PRF has been reported to gradually release autologous growth factors and expressed stronger and more durable effect on the cellular proliferation and differentiation than PRP in vitro This is the first study in the world that will use i-PRF with Orthodontic treatment because of its benefits and easiness of using in dental clinic Study sample that consists of 20 patients Allocation of the sides of intervention PRF injection and control sides is made by computer program Excel
After ensuring of the patients compliance with the terms and conditions of this study the purpose and methods of the study will be explained to the patients using Information Sheet In case of approval to participate the patients asked to sign the Informed Consent
Extra Intra-oral photographs impressions and clinical examination will be made
Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time 20ml of patients blood will be withdrawn and centrifuged 700 rpm within 3 minutes to get 4ml i-PRF PRF will be injected at the area of the extracted first premolar The first point place is in the buccal interventional side supra periosteal injection and the second point place is in the palatal interventional sidesub periosteal injection PRF will be injected twice at the beginning and at the middle of the canine retraction
High resolution CBCT will be taken before the beginning of canine retraction T0 and after 6 months T1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None