The Effect of Multiple Injections of (PRF) on The Rate of... | NCT05766618

NCT05766618

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Measure	Description	Time Frame
Assess Periodontal health at the injection side.	2. Assess Periodontal health on the injection side through periodontal charting mainly propping depth.	5 months

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Mohamed M Alkhawaga, BDS	Contact	+201099345694		mohamed.mamdouh@dentistry.cu.edu.eg

Facility	Status	City	State	ZIP	Country	Contacts
Vice president of graduate studies of Cairo University	Recruiting	Cairo	Giza Governorate		Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31155698	Result	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.
25439213	Result	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.