Evaluation of Effect of Platelet-Rich Fibrin on Orthodontic Tooth Movement: a Split Mouth Randomised Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- : Distance of canine retraction in millimeters / month in different groups-control, single dose PRF and multiple doses of PRF.
研究概览
简要总结
it is a randomized control trial and aims at investigating the effects of PRF on rate of tooth movement and root length to be tested on larger sample size of pakistani population
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, Investigator)
盲法说明
This trial will be a double-blind trial where the examiner and the patient both will be blind. Since the placebo and i-PRF will be in similar looking glass tubes the patient and the investigator/ examiner who is the orthodontist will not know which side of the maxilla has been intervened with i-PRF and which one with the placebo injection.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who give written consent to participate in the research
- •Orthodontic patients with good oral hygiene
- •Patients with periodontal probing depths≤3 mm with no bone loss
- •Patients undergoing orthodontic treatment with fixed appliance and requiring upper first premolar extraction followed by canine retraction
- •Patients treated with canine retraction utilizing maximum anchorage in the maxillary arch from trans-palatal arch anchorage device
- •Patients with mild to moderate crowding in maxillary arch
- •Patients with no previous history of orthodontic treatment
排除标准
- •patients who are smokers, health compromised (such as diabetics, with bone disorders, immunocompromised, known with blood dyscrasias) will be excluded from the trial. Patients with drug history of non-steroidal anti-inflammatory drugs, anti-inflammatory (in last 30 days), antibiotic therapy in last 3 months and those women who are pregnant will also be excluded.
- •Other exclusion criteria will be patients with hypodontia, impacted/ectopic canines, extracted first molars, and patients who may discontinue the trial with or without assigning any reasons and those not consenting to participate in the research.
研究组 & 干预措施
EXPERIMENTAL
Only the test side that will be intervened with i-PRF will be obtained from the upper liquid layer and will be placed in dental injectors using a 27 mm gauged needle. During the first application the amount of i-PRF will be standardized as 4 mL and injected through intra-ligamental into the disto-buccal and disto-palatal side of the canine tooth (2 mL for each side) and at the time of second intervention i.e 8th week form the baseline intramucosal injection will be administered equidistant from the maxillary canine and second premolar, 2ml on buccal side and 2ml on palatal side) after anesthetizing the region with local anesthesia (2% Lignocaine).
干预措施: Platelet rich fibrin (Biological)
CONTROL
On control side saline was injected using a 27 mm gauged needle. During the first application the saline was injected through intra-ligamental into the disto-buccal and disto-palatal side of the canine tooth (2 mL for each side) and at the time of second intervention i.e 8th week form the baseline intramucosal injection will be administered equidistant from the maxillary canine and second premolar, 2ml on buccal side and 2ml on palatal side) after anesthetizing the region with local anesthesia (2% Lignocaine).
干预措施: Platelet rich fibrin (Biological)
结局指标
主要结局
: Distance of canine retraction in millimeters / month in different groups-control, single dose PRF and multiple doses of PRF.
时间窗: 5 months
次要结局
- Difference in root length of canine measured before and after canine retraction and compared amongst different groups(5 month)
研究者
Fahad Iqbal Farooqui
Lecturer
Dow University of Health Sciences