The Effect of Multiple Injections of (PRF) on The Rate of Canine Retraction

NCT05766618 | Unknown Phase 3

• 1 other identifier: I-PRF in orthodontics
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

this clinical trial aims to prove that multiple injections will produce a steady rate of acceleration of orthodontic tooth movement.

Conditions

Platelet-Rich Fibrin; Acceleration; Orthodontics

Keywords

injectable platelets rich fibrin

Outcome Measures

Primary Outcomes (1)

• Rate of canine retraction.

  Rate of orthodontic tooth movement will be measured by calculating the difference in the canine position in mm throughout digital superimposition of consecutive digital models that will be made every four weeks.

  5 months

Secondary Outcomes (1)

• 1. Assess bone level between intervention and control side.

  bone level will be measured at the beginning of the study (T1) and by the fifth month of the study (T5)

Other Outcomes (1)

• Assess Periodontal health at the injection side.

  5 months

Study Arms (2)

injection site

EXPERIMENTAL

it is the arm where the patients will receive the PRF injection intraligamentally in distobuccal, and distopalatal areas of the distal surface of the canine also submucosal injection will be given buccally and palatially (0.25mm) for each side in either the right or left side of the arch.

Procedure: Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement

control site

NO INTERVENTION

it is the arm where the patients will not receive any injection with the same method of retraction as the intervention side.

Interventions

Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement PROCEDURE

Preparatory phase * Space closure will be done on a 17x25 stainless steel wire * Both molars will be indirectly anchored to the miniscrew * Extend closing coil spring of suitable length from the canine hock to the first molar hock for retraction. * Apply a force of 150gm for each side. The force is measured by a force gauge and activated each visit to keep it constant all over the retraction phase. PRF Injection protocol * The First injection will be 3 weeks before extraction * By the end of the fourth week the patients will be referred for pre-intervention records. Upper arch CBCT will be obtained to take preintervention measurements of the alveolar bone. * At the time of canine retraction patient will receive another injection immediately and an alginate impression will be taken * follow up every month and injection will be repeated month after month with an observational period of 5 months.

Also known as: The effect of autologous platelet concentrates on orthodontic tooth movement

injection site

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• adult patient
• Full set of permanent dentition (excluding third molars).
• Good oral hygiene
• protrusion cases that require extraction of premolars (Bimaxillary protrusion or class II div 1)

You may not qualify if:

• History of previous orthodontic treatment.
• Systemic disease or drugs affecting tooth movement.
• Smokers
• Poor oral health that precludes orthodontic treatment (presence of caries, active white spots, or periodontal diseases)
• Severe crowding cases with ectopic erupted canines

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Vice president of graduate studies of Cairo University

Cairo, Giza Governorate, Egypt

RECRUITING

Related Publications (31)

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• 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.

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• El-Timamy A, El Sharaby F, Eid F, El Dakroury A, Mostafa Y, Shaker O. Effect of platelet-rich plasma on the rate of orthodontic tooth movement. Angle Orthod. 2020 May 1;90(3):354-361. doi: 10.2319/072119-483.1.

  PMID: 33378433 RESULT

• Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.

  PMID: 33459765 RESULT

• KINGSLEY CS. Blood coagulation; evidence of an antagonist to factor VI in platelet-rich human plasma. Nature. 1954 Apr 17;173(4407):723-4. doi: 10.1038/173723a0. No abstract available.

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  PMID: 15085519 RESULT

• He L, Lin Y, Hu X, Zhang Y, Wu H. A comparative study of platelet-rich fibrin (PRF) and platelet-rich plasma (PRP) on the effect of proliferation and differentiation of rat osteoblasts in vitro. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):707-13. doi: 10.1016/j.tripleo.2009.06.044.

  PMID: 19836723 RESULT

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  PMID: 20373539 RESULT

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.

  PMID: 16504849 RESULT

• Del Corso M, Vervelle A, Simonpieri A, Jimbo R, Inchingolo F, Sammartino G, Dohan Ehrenfest DM. Current knowledge and perspectives for the use of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in oral and maxillofacial surgery part 1: Periodontal and dentoalveolar surgery. Curr Pharm Biotechnol. 2012 Jun;13(7):1207-30. doi: 10.2174/138920112800624391.

  PMID: 21740371 RESULT

• Reichert C, Kutschera E, Plotz C, Scharf S, Golz L, Fimmers R, Fuhrmann C, Wahl G, Braumann B, Jager A. Incidence and severity of gingival invaginations associated with early versus late initiation of orthodontic space closure after tooth extraction : A multicenter pilot and randomized controlled trial. J Orofac Orthop. 2017 Sep;78(5):415-425. doi: 10.1007/s00056-017-0098-9. Epub 2017 Jun 28.

  PMID: 28660421 RESULT

• Farshidfar N, Amiri MA, Firoozi P, Hamedani S, Ajami S, Tayebi L. The adjunctive effect of autologous platelet concentrates on orthodontic tooth movement: A systematic review and meta-analysis of current randomized controlled trials. Int Orthod. 2022 Mar;20(1):100596. doi: 10.1016/j.ortho.2021.10.004. Epub 2021 Dec 2.

  PMID: 34866025 RESULT

• Sivarajan S, Ringgingon LP, Fayed MMS, Wey MC. The effect of micro-osteoperforations on the rate of orthodontic tooth movement: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2020 Mar;157(3):290-304. doi: 10.1016/j.ajodo.2019.10.009.

  PMID: 32115107 RESULT

• Mheissen S, Khan H, Alsafadi AS, Almuzian M. The effectiveness of surgical adjunctive procedures in the acceleration of orthodontic tooth movement: A systematic review of systematic reviews and meta-analysis. J Orthod. 2021 Jun;48(2):156-171. doi: 10.1177/1465312520988735. Epub 2021 Feb 5.

  PMID: 33546565 RESULT

• Alfailany DT, Hajeer MY, Aljabban O, Mahaini L. The Effectiveness of Repetition or Multiplicity of Different Surgical and Non-Surgical Procedures Compared to a Single Procedure Application in Accelerating Orthodontic Tooth Movement: A Systematic Review and Meta-Analysis. Cureus. 2022 Mar 12;14(3):e23105. doi: 10.7759/cureus.23105. eCollection 2022 Mar.

  PMID: 35296053 RESULT

• Figueiredo DS, Houara RG, Pinto LM, Diniz AR, de Araujo VE, Thabane L, Soares RV, Oliveira DD. Effects of piezocision in orthodontic tooth movement: A systematic review of comparative studies. J Clin Exp Dent. 2019 Nov 1;11(11):e1078-e1092. doi: 10.4317/jced.56328. eCollection 2019 Nov.

  PMID: 31700581 RESULT

• Elmotaleb MAA, Elnamrawy MM, Sharaby F, Elbeialy AR, ElDakroury A. Effectiveness of using a Vibrating Device in Accelerating Orthodontic Tooth Movement: A Systematic Review and Meta-Analysis. J Int Soc Prev Community Dent. 2019 Jan-Feb;9(1):5-12. doi: 10.4103/jispcd.JISPCD_311_18. Epub 2019 Feb 14.

  PMID: 30923687 RESULT

• Bakdach WMM, Hadad R. Effectiveness of low-level laser therapy in accelerating the orthodontic tooth movement: A systematic review and meta-analysis. Dent Med Probl. 2020 Jan-Mar;57(1):73-94. doi: 10.17219/dmp/112446.

  PMID: 32314880 RESULT

• Imani MM, Golshah A, Safari-Faramani R, Sadeghi M. Effect of Low-level Laser Therapy on Orthodontic Movement of Human Canine: a Systematic Review and Meta-analysis of Randomized Clinical Trials. Acta Inform Med. 2018 Jun;26(2):139-143. doi: 10.5455/aim.2018.26.139-143.

  PMID: 30061788 RESULT

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• Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.

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• Cagli Karci I, Baka ZM. Assessment of the effects of local platelet-rich fibrin injection and piezocision on orthodontic tooth movement during canine distalization. Am J Orthod Dentofacial Orthop. 2021 Jul;160(1):29-40. doi: 10.1016/j.ajodo.2020.03.029. Epub 2021 May 4.

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• Choukroun J, Ghanaati S. Reduction of relative centrifugation force within injectable platelet-rich-fibrin (PRF) concentrates advances patients' own inflammatory cells, platelets and growth factors: the first introduction to the low speed centrifugation concept. Eur J Trauma Emerg Surg. 2018 Feb;44(1):87-95. doi: 10.1007/s00068-017-0767-9. Epub 2017 Mar 10.

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MeSH Terms

Interventions

proliferation regulatory factors, human urine

Study Officials

• Mohamed M Alkhawaga, BDS

  Cairo University

  PRINCIPAL INVESTIGATOR

• Fady Fahim, phD

  Cairo University

  STUDY DIRECTOR

• Sally Magdy, phD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mohamed M Alkhawaga, BDS

CONTACT

+201099345694; mohamed.mamdouh@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor: Mohamed Mamdouh Mohamed Elmoghazy Alkhawaga

Model Details: This study is a split-mouth randomized, controlled single-center superiority trial, with two parallel groups with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 13, 2023
• Study Start: April 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

EG (1)