Effect of Injectable Platelet-rich Fibrin (i-PRF) on the Rate of Orthodontic En Masse Retraction of Maxillary Anterior Teeth: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Rate of En masse retraction
研究概览
简要总结
The aim of this study is to investigate the effect of local injection of injectable platelet rich fibrin (i-PRF) on the rate of orthodontic en masse retraction of anterior teeth clinically and to report any associated pain as well.
详细描述
Trial will be carried on 2 groups, each involve 13 participants with a total of 26 participants.
- Subject examination to ensure he/she meets the eligibility criteria of the research.
- Leveling and alignment using fixed orthodontic appliance.
- Upper first premolars extraction as a part of the orthodontic treatment planning.
- With the starting of en masse retraction, injection of the (i-prf) obtained from venous sample palatally and distally to the anterior teeth in the intervention group, and sham injection in the control group. The injection in both groups will be done just before retraction, 21 and 42 days after beginning of retraction Rate of en masse retraction will be calculated for patients in both groups at the monthly basis for for months after starting en masse retraction, data will be analyzed statistically.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Data assessment will be blinded as an assessor not participating in the study will be responsible for measuring the rate of en masse retraction, as the patient name could be hidden during data analysis. The models will be coded with numbers assigned to the participants, and will be sent to an assessor not participating in the research.
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Orthodontic patients with and age range (16 - 30) years.
- •Protruded upper anterior teeth requiring extraction of first premolars and anterior teeth retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division
- •Patients with full permanent dentition (with the exception of third molars).
- •Healthy dental and periodontal condition with good oral hygiene
排除标准
- •Patients with extensive restorations on the anterior teeth.
- •Subjects taking medication affecting inflammatory process of the orthodontic tissue reaction.
- •History of previous orthodontic treatment or trauma to the anterior teeth.
- •Syndromic patients and patients with systemic diseases.
- •Poor oral hygiene or periodontal diseases.
研究组 & 干预措施
intervention group
Intervention group subjects will receive injectable platelet rich fibrin (i-prf) . The (i-prf) will be injected in the periodontal ligament of maxillary anterior teeth during en masse retraction.The injection sites will be the sites of bone compression to target the surfaces of the bone where osteoclastogenesis and bone resorption occurs during en masse retraction.
Considering that the obtained (i-prf) after centrifuging would be 4 ml, 1 ml will be injected intraligamentally distal to the right and left canines, and 0.5 ml will be injected intraligamentally palatal to each incisor. The study group will receive i-PRF intraligamentally in the periodontal ligament space of the maxillary six anterior teeth three times as follow, just before anterior teeth retraction, and after 21 days of the retraction, and after 42 days of the retraction. Before each time of injection, an anesthetic solution will be administered for pain control.
干预措施: injectable platelet rich fibrin(i-prf) (Biological)
control group
Subjects in the control group will only receive sham (placebo) injection three successive times with and interval of 21days between each injection, similar to the timepoints of (i-prf) injection in the intervention group. Also the sites of injection will be similar to the sites of injection of the intervention group; 1 ml of the placebo agent will be injected intraligamentally distal to the right and left canines, and 0.5 ml will be injected intraligamentally palatal to each incisor. An anesthetic solution will be administered for pain control before the administration of the sham injections.
干预措施: Sham Injection (Drug)
结局指标
主要结局
Rate of En masse retraction
时间窗: 4 months
Alginate impression will be taken for each participant to obtain a plaster model obtained at five time points: before incisor retraction (T0), after one month (T1), after two months (T2), after three months(T3), and after four months (T4) of retraction. The models will be coded with numbers assigned to the participants, and will be sent to an assessor not participating in the research. In both groups, the amount of space closure will be calculated by a digital caliper in millimeters for each time point (T) and averaged for right and left sides.
次要结局
- Associated Pain(4 months)
研究者
Ahmed magdy Mohamed Sabrah
PhD Candidate
Cairo University