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临床试验/CTRI/2024/04/066015
CTRI/2024/04/066015尚未招募不适用

Comparison Of mini-implant supported maxillary canine retraction with and without submucosal injection of autologous platelet rich plasma :A prospective ,single –blind ,split mouth randomized controlled trial.

Arushi Malhotra1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年4月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
18
试验地点
1
主要终点
The predictor variable is the canine retraction technique i.e canine retraction with and without PRP injection. The canine retraction rate is our primary outcome.

研究概览

简要总结

The study is a Prospective ,Single-blind ,Randomized controlled trial with a Split-mouth design to evaluate the efficacy of submucosal injection of platelet rich plasma (PRP) for accelerating orthodontic tooth movement (OTM) in fixed orthodontic patients . The study will be conducted at the Department of orthodontics and dentofacial Orthopaedics (Bhojia dental collage and hospital ,Baddi). The study population will include subjects with permanent dentition of either gender between 16 and 25 years of age requiring bilateral extraction of maxillary first permanent molar as part of their comprehensive treatment. The inclusion criteria also specify critical anchorage ,adequate inter-radicular distance between maxillary first permanent molar and second premolar for insertion of mini screws , and good gingival and periodontal health . The intervention involves the application of fixed orthodontic brackets and extraction of maxillary first premolars for all patients. The principal investigator will be responsible for examining the subjects and determining their eligibility . The trial coordinator will evaluate the rate of canine retraction , and the follow-up process will involve assessing the subjects and analyzing the data. The study will be conducted according to the 1975 Helsinki declaration guidelines as revised in 2013 . statistical analysis will be done with SPSS version 22.0.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
16.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Age range 16-25 years Critical anchorage Adequate interradicular distance between the maxillary first permanent molar and second premolar for insertion of mini screws.
  • Good gingival and periodontal health (probing depth ≤3mm,gingival index score ≤1).
  • No systemic disease Full development of teeth except 3rdmolars.
  • Patients requiring bilateral extraction of maxillary 1st premolar as part of their comprehensive treatment.
  • Platelet count above 100000/mL.

排除标准

  • Clotting or bleeding disorders.
  • Smokers, alcoholism Pregnancy Systemic disease or medications intake that interfere with orthodontic tooth movement or platelet count.
  • Sign and symptom of periodontal disease.
  • Gingival inflammation.
  • (gingivitis) Poor oral hygiene for ≥ 2 visits.
  • History of previous orthodontic treatment.
  • Dental caries.
  • Long term use of antibiotics,phenytoin, cyclosporine,anti-inflammatory drugs, systemic corticosteroids and calcium channel blockers.
  • Crossbite or deviation during jaw closure caused by occlusal interferences.
  • Patient with severe tooth displacement (eg ectopic canine).

结局指标

主要结局

The predictor variable is the canine retraction technique i.e canine retraction with and without PRP injection. The canine retraction rate is our primary outcome.

时间窗: Base time point T0, then every monthly time point till four months i.e. T1, T2, T3, T4

次要结局

  • Canine Rotations & molar rotations will be measured at monthly time intervals till 4 months from the base time point(base time point T0, then monthly intervals T1, T2, T3 & T4)
  • Pain scores will be measured on VAS at base point, at 24 hours & after 7 days(base point, at 24 hours , after 7 days)

研究者

发起方
Arushi Malhotra
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Arushi malhotra

Bhojia Dental college and hospital Bhud , Nalagarh

研究点 (1)

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