The Effect of Multiple Injections of Platelets Rich Fibrin (i-PRF) on The Rate of Canine Retraction A Split-mouth: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Rate of canine retraction.
研究概览
简要总结
this clinical trial aims to prove that multiple injections will produce a steady rate of acceleration of orthodontic tooth movement.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •History of previous orthodontic treatment.
- •Systemic disease or drugs affecting tooth movement.
- •Poor oral health that precludes orthodontic treatment (presence of caries, active white spots, or periodontal diseases)
- •Severe crowding cases with ectopic erupted canines
研究组 & 干预措施
injection site
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.
干预措施: Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement (Procedure)
control site
it is the arm where the patients will not receive any injection with the same method of retraction as the intervention side.
结局指标
主要结局
Rate of canine retraction.
时间窗: 5 months
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.
次要结局
- 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))
研究者
Mohamed Mamdouh Mohamed Elmoghazy Alkhawaga
Doctor: Mohamed Mamdouh Mohamed Elmoghazy Alkhawaga
Cairo University