Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133361
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-11-10
Brief Title:
The Effect of Platelet-rich Plasma on the Rate and Type of Orthodontic Tooth Movement
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Evaluation of the Rate and Type of Orthodontic Tooth Movement When Injecting Platelet-rich Plasma During Mini-implant-based Segmented En-masse Retraction of Upper Anterior Teeth A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This study aims to assess the effect of PRP on the rate and type of OTM during en-masse frictionless retraction of maxillary anterior teeth using a segmental arch technique
Thirty adult patients exhibiting class II division 1 malocclusion requiring upper first premolar extractions followed by en-masse retraction will participate in the study They will be randomly and equally distributed into the PRP group G1 and the control group G2 The injection of PRP will be performed pre-retraction The rate of orthodontic tooth movement will be assessed clinically by measuring the extraction space with a digital caliper The cephalometric radiographs will evaluate the type of OTM at the beginning of en-masse retraction T0 and at the middle of en-masse retraction T1
Thirty adult patients exhibiting class II division 1 malocclusion requiring upper first premolar extractions followed by en-masse retraction will participate in the study They will be randomly and equally distributed into the PRP group G1 and the control group G2 The injection of PRP will be performed pre-retraction The rate of orthodontic tooth movement will be assessed clinically by measuring the extraction space with a digital caliper The cephalometric radiographs will evaluate the type of OTM at the beginning of en-masse retraction T0 and at the middle of en-masse retraction T1
Detailed Description:
One of the most important challenges in daily practice is prolonged orthodontic treatment duration Many therapeutic procedures such as chemical interventions have been introduced to minimize orthodontic treatment time Even though all the methods of chemically assisted acceleration of OTM increase the rate of bone turnover and increase the rate of tooth movement however these chemical agents ie hormones or vitamin D3 have many problems such as systemic effects and short half-life which make them not practical in clinical orthodontic Therefore the injection of PRP has been proposed
-In both groups two first upper premolars were extracted In all patients fixed metal orthodontic brackets with MBT prescription 0022 were bonded After the arches were leveled and aligned a rigid sectional archwire 0021 x 0025 in stainless steel was used for the anterior six teeth To strengthen anchorage microscrews diameter 16 mm length 10 mm were inserted at 8mm from the archwire into the inter-radicular space between the maxillary first molar and second premolar
Two crimpable hooks were used with a height of 8 mm between the lateral incisor and canine on both sides of the sectional wire 0021x0025 to pass the force vector as close as possible to the center of resistance En-masse retraction began one week after premolar extraction using calibrated nickel-titanium coil springs with 175 g force per side
-In PRP 48 ml of blood was collected from the patient in sterile tubes with ACD-A as an anticoagulant PRP was prepared as follows Initially the blood was centrifuged at 2000 rpm for 6 minutes After separation of the blood PRP and some Platelet-Poor Plasma PPP were collected and mixed in a dry tube and then a second centrifugation was done at 2700 rpm for 3 minutes After the second centrifugation the lower 13rd of the tube is PRP About 4 ml of PRP was collected from the tube and then the patient was injected with it After regional anesthesia for pain control 05 ml of PRP was slowly injected submucosally palatal to each tooth from the right canine to the left canine using a 1cc syringe Paracetamol was described for the patient to control pain and ensure confirming not to use ibuprofen or another NSAIDS The injection was applied one time
-In both groups two first upper premolars were extracted In all patients fixed metal orthodontic brackets with MBT prescription 0022 were bonded After the arches were leveled and aligned a rigid sectional archwire 0021 x 0025 in stainless steel was used for the anterior six teeth To strengthen anchorage microscrews diameter 16 mm length 10 mm were inserted at 8mm from the archwire into the inter-radicular space between the maxillary first molar and second premolar
Two crimpable hooks were used with a height of 8 mm between the lateral incisor and canine on both sides of the sectional wire 0021x0025 to pass the force vector as close as possible to the center of resistance En-masse retraction began one week after premolar extraction using calibrated nickel-titanium coil springs with 175 g force per side
-In PRP 48 ml of blood was collected from the patient in sterile tubes with ACD-A as an anticoagulant PRP was prepared as follows Initially the blood was centrifuged at 2000 rpm for 6 minutes After separation of the blood PRP and some Platelet-Poor Plasma PPP were collected and mixed in a dry tube and then a second centrifugation was done at 2700 rpm for 3 minutes After the second centrifugation the lower 13rd of the tube is PRP About 4 ml of PRP was collected from the tube and then the patient was injected with it After regional anesthesia for pain control 05 ml of PRP was slowly injected submucosally palatal to each tooth from the right canine to the left canine using a 1cc syringe Paracetamol was described for the patient to control pain and ensure confirming not to use ibuprofen or another NSAIDS The injection was applied one time
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