Clinical trial NCT05766618: The Effect of Multiple Injections of (PRF) on The Rate of Canine Retraction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Platelet-Rich Fibrin
Acceleration
Orthodontics
Keywords: injectable platelets rich fibrin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a split-mouth randomized, controlled single-center superiority trial, with two parallel groups with a 1:1 allocation ratio.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of canine retraction.
timeFrame: 5 months
Secondary outcomes:
measure: 1. Assess bone level between intervention and control side.
timeFrame: bone level will be measured at the beginning of the study (T1) and by the fifth month of the study (T5)
Other outcomes:
measure: Assess Periodontal health at the injection side.
timeFrame: 5 months
Locations:
city: Cairo
country: Egypt
facility: Vice president of graduate studies of Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Mohamed M Alkhawaga, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Fady Fahim, phD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Sally Magdy, phD
role: STUDY_CHAIR
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