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临床试验/CTRI/2024/07/070006
CTRI/2024/07/070006尚未招募Phase 3 4

Comparative Evaluation of Efficacy of the Novel PRP Loop with Opus Loop for Anterior EnMasse Retraction in Angles Class I Deweys Type 2 Malocclusion A Single Blinded Randomized Clinical Trial.

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
PRP loop may be an effective tool for anterior en-masse retraction and may lead to minimum anchorage loss.

研究概览

简要总结

Optimal space closure is a pivotal aspect of orthodontic treatment, particularly challenging in patients with bimaxillary protrusions and Angle’s Class II Division 1 malocclusion. Two primary methods, friction and frictionless mechanisms, are employed for anterior teeth retraction. However, concerns over prolonged treatment duration and increased anchorage demands have prompted exploration into non-frictional approaches. Biomechanical properties significantly influence the efficacy of retraction loops, with ideal loops exhibiting high moment-to-force (M/F) ratios and low force-to-deflection (F/D) ratios. Inspired by existing designs, the "PRP loop" was developed, showing promising biomechanical characteristics in a finite element study. However, its clinical efficacy remains unexplored. This study aims to evaluate and compare the PRP loop with the Opus loop for anterior en-masse retraction in Angle’s Class I Dewey’s Type 2 malocclusion.

Literature review reveals studies highlighting the importance of loop design on tooth movement efficiency and anchorage preservation. Methodology involves a prospective, single-blinded randomized clinical trial with 30 patients divided into PRP and Opus loop groups. Treatment procedures include initial alignment, maxillary premolar extractions, and retraction using respective loops. Evaluation criteria encompass retraction rate, efficacy, and anchorage loss measured through clinical and radiographic assessments.

Statistical analysis will employ Student’s t-test with GraphPad Prism 7.0 and SPSS 27.0 software. Results will contribute to understanding the clinical effectiveness of the PRP loop compared to the Opus loop, providing valuable insights into optimizing space closure techniques in orthodontic practice.

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
15.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Age- 15 to 30 years patients with Angle’s Class I Dewey’s type 2 malocclusion.
  • Patients having average growth pattern requiring maxillary premolar extractions.
  • Moderate to critical anchorage cases.
  • Those with healthy periodontal status, without periodontal pocket depths more than 2 to 3 mm and the ones who require fixed orthodontic treatment.

排除标准

  • Those with Angle’s Class II and III malocclusion.
  • Patients having inborn and developmental syndromes.
  • Systemic disorders like clotting diseases or conditions such as pregnancy.

结局指标

主要结局

PRP loop may be an effective tool for anterior en-masse retraction and may lead to minimum anchorage loss.

时间窗: 1st assessment- 2months | 2nd assessment- after extraction space closure

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Krushnali Kolhatkar

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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