Evaluation of Efficacy of Injectable Platelet-Rich Plasma (PRP) in Reducing Alveolar Bone Resorption Following Rapid Maxillary Expansion (RME): A Cone Beam Computed Tomography (CBCT) Assessment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Changes in buccal alveolar bone height loss and thickness reduction amount
研究概览
简要总结
The purpose of this study is to determine if the injection of Platelet-rich plasma (PRP) is effective in reducing alveolar bone loss that happens after each rapid maxillary expansion (RME) on the buccal aspect of the posterior teeth.
16 patients with a skeletal maxillary constriction aged between 10-16 years old will get into orthodontic treatment to widen the maxilla using Hyrax appliance.
An amount of patient blood will be withdrawn and centrifuged to get PRP. Then the PRP will be injected in one half of each patient mouth in a split-mouth design, beneath the buccal periosteal of the first molars and first premolars, the halves will be chosen randomly.
High resolution CBCT images will be taken before and after orthodontic treatment to analyze buccal bone thickness and height changes.
详细描述
Correction of the maxillary transverse discrepancy is essential for treatment of various types of malocclusions. Palatal expansion is the most common method used to improve the transverse dimensions of the maxilla especially Rapid maxillary expansion (RME) . RME is associated with intermittent high force systems which cause lateral flexion of the alveolar processes and buccal displacement of the anchorage teeth . Displacement of these teeth outside the alveolar anatomic limits can damage the periodontium and finally compromising tooth longevity.
Several researchers have studied the incidence of buccal dehiscence and fenestrations after RME , using CBCT Images.
From here It was thought about using a method to eliminate these dangerous side effects. It was found that platelet rich plasma (PRP) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).
This is the first study in the world that will use PRP with orthodontic treatment, because of its benefits and easiness of using in dental clinic.
Study sample, that consists of 16 patients, was calculated using (G-power sample size calculator) depending on the buccal alveolar bone thickness changes, with a study power of 95%.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-16 years old patients
- •Complete emergence of first molars and first premolars
- •Clinical maxillary transverse deficiency
- •Good oral hygiene (Gingival index <1) according to Silness & loe 1964
- •( Plaque index <1)
排除标准
- •The presence of a medical situations that affects orthodontic treatment and periodontal health
- •The presence of drug therapy affect orthodontic treatment and periodontal health
- •Bad oral hygiene (gingival and plaque index >1)
- •Patient with physical and psychological limitations
- •Metallic restorations or endodontic treatments on the appliance supporting teeth (first molars and first premolars)
- •Craniofacial anomalies
- •Previous orthodontic treatment
- •Patients who did not correctly follow the protocol of activation
- •Patients who did not return for control dental appointments
- •Patients whose cementation of the appliance failed
- •Patients whose dental structures were difficult to visualize on the CBCT scans as a result of artifact
研究组 & 干预措施
Platelet Rich Plasma
Platelet Rich Plasma (PRP) will be injected beneath the buccal periosteal of the first molar and premolar in one mouth side with a split-mouth design before the beginning of Rapid Maxillary Expansion and after 7 days of it.
干预措施: Platelet Rich Plasma (Drug)
No Platelet Rich Plasma
No Platelet Rich Plasma (PRP) will be injected in the other mouth side with a split-mouth design during Rapid Maxillary Expansion.
干预措施: No Platelet Rich Plasma (Drug)
结局指标
主要结局
Changes in buccal alveolar bone height loss and thickness reduction amount
时间窗: Evaluation before and after RME. (after 3 months)
Buccal alveolar bone height loss and thickness reduction amount (The incidence of Dehiscence) as a result of RME (On the intervention compared to non-intervention side) before and after expansion. Assessment will be done using CBCT before treatment (T0) and after 3 months (T2)
次要结局
- Changes in the appliance supporting teeth inclination(Evaluation before and after RME. (after 3 months))
- Pain levels(3 months)
- Patient acceptance(3 months)