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

Orthodontics Clinical Trial

Official title:

The Effect of Multiple Injections of Platelets Rich Fibrin (i-PRF) on The Rate of Canine Retraction A Split-mouth: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766618
• Other study ID #: I-PRF in orthodontics
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: Mohamed M Alkhawaga, BDS
• Phone: +201099345694
• Email: mohamed.mamdouh[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Platelet-rich fibrin injection is a second-generation platelet concentrate, prepared from centrifuged blood which is a rich source of platelets, stem cells, and growth factors seven times greater than that released by platelet-rich plasma. It is a simplified procedure with no biochemical manipulation of blood, free from anticoagulants which are known to inhibit wound healing or any gelling agent, and easily usable with a low rate of mistakes during the preparation procedure.

A variety of growth factors are released by PRF such as platelet-derived growth factor (PDGF), transforming growth factor β (TGF-β), and vascular endothelial growth factor (VEGF), which play a crucial role in angiogenesis, collagen synthesis, and bone regeneration.

Treatment with extraction especially in adult patients may take a longer time due to reported increase in bone density and lower bone regenerative rate. Also, the retraction process to close extraction spaces most of the time is accompanied by bone loss and root resorption as reported in the previous studies. i-PRF can accelerate tooth movement, in addition, prevent tooth retraction undesirable side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Orthodontics
• Platelet-Rich Fibrin

Intervention

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

Locations

Country	Name	City	State
Egypt	Vice president of graduate studies of Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (31)

Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0. — View Citation

Adarsh K, Sharma P, Juneja A. Accuracy and reliability of tooth length measurements on conventional and CBCT images: An in vitro comparative study. J Orthod Sci. 2018 Sep 6;7:17. doi: 10.4103/jos.JOS_21_18. eCollection 2018. — View Citation

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 an — View Citation

Arqub SA, Gandhi V, Iverson MG, Ahmed M, Kuo CL, Mu J, Dutra E, Uribe F. The effect of the local administration of biological substances on the rate of orthodontic tooth movement: a systematic review of human studies. Prog Orthod. 2021 Feb 1;22(1):5. doi: — View Citation

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. — View Citation

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. E — View Citation

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 c — View Citation

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: Periodont — View Citation

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 — View Citation

Dohan Ehrenfest DM, Del Corso M, Diss A, Mouhyi J, Charrier JB. Three-dimensional architecture and cell composition of a Choukroun's platelet-rich fibrin clot and membrane. J Periodontol. 2010 Apr;81(4):546-55. doi: 10.1902/jop.2009.090531. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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; — View Citation

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/j — View Citation

Gollapudi M, Bajaj P, Oza RR. Injectable Platelet-Rich Fibrin - A Revolution in Periodontal Regeneration. Cureus. 2022 Aug 31;14(8):e28647. doi: 10.7759/cureus.28647. eCollection 2022 Aug. — View Citation

Gupta P, Bhagyalakshmi A, Avinash BS, Prashant A, Raghunath N. Evaluation of injectable platelet-rich fibrin effect on the rate of canine retraction and alkaline phosphatase levels: An in-vivo study. Am J Orthod Dentofacial Orthop. 2022 Aug 22:S0889-5406( — View Citation

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;1 — View Citation

Huang H, Williams RC, Kyrkanides S. Accelerated orthodontic tooth movement: molecular mechanisms. Am J Orthod Dentofacial Orthop. 2014 Nov;146(5):620-32. doi: 10.1016/j.ajodo.2014.07.007. Epub 2014 Oct 28. — View Citation

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.20 — View Citation

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. — View Citation

Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available. — View Citation

Mheissen S, Daraqel B, Alzoubi EE, Khan H. Effectiveness of platelet-rich concentrates on the rate of orthodontic tooth movement: a systematic review and meta-analysis. Eur J Orthod. 2022 Sep 3:cjac049. doi: 10.1093/ejo/cjac049. Online ahead of print. — View Citation

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 — View Citation

Miron RJ, Fujioka-Kobayashi M, Bishara M, Zhang Y, Hernandez M, Choukroun J. Platelet-Rich Fibrin and Soft Tissue Wound Healing: A Systematic Review. Tissue Eng Part B Rev. 2017 Feb;23(1):83-99. doi: 10.1089/ten.TEB.2016.0233. Epub 2016 Oct 10. — View Citation

Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub — View Citation

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 m — View Citation

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.2019.10.00 — View Citation

Song D, Shujaat S, de Faria Vasconcelos K, Huang Y, Politis C, Lambrichts I, Jacobs R. Diagnostic accuracy of CBCT versus intraoral imaging for assessment of peri-implant bone defects. BMC Med Imaging. 2021 Feb 10;21(1):23. doi: 10.1186/s12880-021-00557-9 — 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 — View Citation

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 — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess Periodontal health at the injection side.	2. Assess Periodontal health on the injection side through periodontal charting mainly propping depth.	5 months
Primary	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	1. Assess bone level between intervention and control side.	1. bone level between intervention and control side will be assessed through pre and post retraction CBCT for the upper arch.	bone level will be measured at the beginning of the study (T1) and by the fifth month of the study (T5)