Evaluation the Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Upper Canine Retraction and the Levels of Acceptance and Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of the rate of canine retraction
研究概览
简要总结
Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region , and the other side served as the control. canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side , soldered transpalatal arch will be used as an anchor unit.
Pre- and post distalization dental casts will be evaluated to study rate of canine distalization, over a follow-up period until a Class I canine relationship will be achieved. The levels of Pain and discomfort will be monitored using a questionnaire with a VAS scale administered three times during the first day after prf injection.
详细描述
Reduced orthodontic treatment duration is important for care providers and orthodontic patients.it is also desirable that aesthetic concerns and time dependent adverse events such as discomfort, pain, external root resorption, suboptimal oral hygiene, white spot lesions and dental caries are held to the minimum. Although the surgical assisted accelerated orthodontic tooth movement (such as distraction of periodontal ligament, distraction of dentoalveolus, periodontally accelerated osteogenic orthodontics (PAOO),Corticision, orthognathic surgery, piezocision, piezopuncture and micro osteoperforation). It has been proved to be the most effective one currently, its disadvantages are: it is a bone surgery, and it causes loss of alveolar bone that undermines the periodontal support of the target teeth.
Noninvasive and nonsurgical methods have always been preferred by both the clinicians and the patients. These techniques have ranged from application of biological molecules to innovative technologies such as resonance vibration, cyclic forces, light electrical currents, magnetic field forces, low-intensity laser irradiation and low-level light therapy. Endogenously produced biologicals have been tested based on their roles in the turnover of alveolar bone in response to orthodontic tooth movement as well as during wound healing.
That's why the submucosal injection of platelet rich plasma (PRP) is a technique developed for accelerating orthodontic tooth movement by simulating the effects of bone insult without surgery and loss of alveolar bone, Some researchers found that prp injection created a regional acceleratory phenomenon-like effect which forms the basis of rapid tooth movement compared with conventional orthodontic treatment.
From here it has been thought about using a method to eliminate the surgical techniques' side effects. It has been found that platelet rich fibrin (PRF) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).
PRF characteristics in comparison to platelet rich plasma PRP are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
One blinded
入排标准
- 年龄范围
- 15 Years 至 27 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult healthy patients, Male and female, Age range: 15-27 years.
- •Class II Division 1 malocclusion:
- •Mild / moderate skeletal Class II (ANB ≤7) Overjet ≤10 Normal or excessive facial height (Clinically and then cephalometry assessed using these angles : SN-MP , MM , Y axis) Mild to moderate crowding ≤ 4
- •permanent occlusion.
- •Exist all the upper teeth (except third molars).
- •Good oral and periodontal health:
- •Probing depth < 4 mm No radiographic evidence of bone loss. Gingival index ≤ 1 Plaque index ≤ 1
排除标准
- •Medical problems that affect tooth movement (corticosteroid, NSAIDs, ...)
- •patients have anti indication for oral surgery ( medical - social - psycho)
- •Presence of primary teeth in the maxillary arch
- •Missing permanent maxillary teeth (except third molars).
- •Poor oral hygiene or Current periodontal disease:
- •Probing depth ≥ 4 mm radiographic evidence of bone loss Gingival index > 1 Plaque index > 1
- •Patient had previous orthodontic treatment
- •Craniofacial anomalies (cleft lip and palate patients)
- •coagulation disorders and patients treated with anticoagulants.
- •patients with immunodeficiency disorders
结局指标
主要结局
Change of the rate of canine retraction
时间窗: Before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1) which will be approximately after 6 months from the beginning of canine retraction
The rate of canine retraction defines as the distance traveled in millimeters (mm) divided by the time required (in week). Orthodontic models will be taken before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1). The distance of canine retraction will be calculated by measuring the difference between the initial cast and the final cast using the method described by Ziegler and Ingervall, which rely on Stable palatal reference Points (the medial ends of the third palatal rugae, Midpalatal Suture) and the tips of the canines and then this distance will be divided by the number of intervals (weeks) to give the rate of retraction in millimeters per week. Measurements will be made from the orthodontic models manually by direct technique using digital dental calipers.
次要结局
- pain levels(on the first day after an hour, 2 hours and 6 hours of PRF injection)