Class II Division 1 Malocclusion Clinical Trial
Official title:
Comparison Between The Effect of Platelet Rich Plasma (PRP) and Injectable Platelet Rich Fibrin (I-PRF) on Orthodontic Tooth Movement
Verified date | April 2022 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
60 patients needed therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines were divided to randomly three groups: (1) PRP group: Received PRP injections, (2) I-PRF group: Received I-PRF injections, (3) Control group: conventional treatment with no injections. TPAs were used as an anchor unit. Coil springs were used to distalize the upper canines on 0.019 x 0.025-inch stainless archwires. Alginate impressions and dental casts of the maxillary arch were done at five-time points over a 4-month follow-up period. The amount of canine movement, canine rotation, and anchorage loss were measured on three-dimensional digital models superimposed on the rugae area.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 25, 2020 |
Est. primary completion date | May 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: 1. both male and female subjects 2. 18-25 years old 3. Class II Division 1 malocclusion, treated with extraction of the maxillary first premolars 4. Full permanent dentition 5. Good general and oral health Exclusion Criteria: 1. extreme skeletal class II malocclusion, overjet > 10 mm ANB>7? 2. diseases and medications that were likely to affect bone biology 3. poor oral hygiene 4. previous orthodontic treatment 5. smoking 6. coagulation disorders, or being treated with anticoagulants |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | University of Damascus | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University | Hama University |
Syrian Arab Republic,
Ali Mahmood TM, Chawshli OF. The Effect of Submucosal Injection of Plasma-Rich Platelets on Blood Inflammatory Markers for Patients with Bimaxillary Protrusion Undergoing Orthodontic Treatment. Int J Inflam. 2019 Oct 1;2019:6715871. doi: 10.1155/2019/6715871. eCollection 2019. — View Citation
Dixon V, Read MJ, O'Brien KD, Worthington HV, Mandall NA. A randomized clinical trial to compare three methods of orthodontic space closure. J Orthod. 2002 Mar;29(1):31-6. — View Citation
Rashid A, ElSharaby FA, Nassef EM, Mehanni S, Mostafa YA. Effect of platelet-rich plasma on orthodontic tooth movement in dogs. Orthod Craniofac Res. 2017 May;20(2):102-110. doi: 10.1111/ocr.12146. — View Citation
Reyes Pacheco AA, Collins JR, Contreras N, Lantigua A, Pithon MM, Tanaka OM. Distalization rate of maxillary canines in an alveolus filled with leukocyte-platelet-rich fibrin in adults: A randomized controlled clinical split-mouth trial. Am J Orthod Dentofacial Orthop. 2020 Aug;158(2):182-191. doi: 10.1016/j.ajodo.2020.03.020. Epub 2020 Jun 24. — View Citation
Tehranchi A, Behnia H, Pourdanesh F, Behnia P, Pinto N, Younessian F. The effect of autologous leukocyte platelet rich fibrin on the rate of orthodontic tooth movement: A prospective randomized clinical trial. Eur J Dent. 2018 Jul-Sep;12(3):350-357. doi: 10.4103/ejd.ejd_424_17. — View Citation
Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in canine retraction rate | The amount of canine retraction per month was calculated by measuring the distance from the canine cusp tip in the baseline model to the canine cusp tip in the next superimposed model. The amount of distance being retracted in millimeters was divided to the duration of retraction in months to give an estimation of the retraction rate. | The estimation took place at five time points: the beginning of tooth movement (T0) and at 4, 8, 12, and 16 weeks following T0 | |
Secondary | Change in the maxillary first molar position (anchorage loss) | Anchorage loss was calculated in the superimposed digital models from the mesial central fossa of a maxillary first molar of the baseline model the mesial central fossa of maxillary first molar in the next superimposed model. | T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction | |
Secondary | Change in canine rotation | The amount of canine rotation was measured in superimposed digital models. Mesial and distal contact points of the canines were used to make a horizontal line that would make an angle with the similar line in the next superimposed model, this angle referred to the amount of canine rotation between the two superimposed models. | T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction |
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