跳至主要内容
临床试验/CTRI/2025/07/090218
CTRI/2025/07/090218
尚未招募
2/3 期

Comparative Evaluation of the Effects of Injectable Platelet Rich Fibrin(i-PRF) on Rate of Maxillary Canine Retraction – A Split Mouth Randomized Trial

Dr Himanshu Kumar Sah1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月15日最近更新:

概览

阶段
2/3 期
状态
尚未招募
发起方
Dr Himanshu Kumar Sah
入组人数
20
试验地点
1
主要终点
Rate of canine retraction will compared in the experimental group and control group.

概览

简要总结

A split-mouth, randomized controlled trial will be conducted using a single-center, single-blinded (outcome assessor), parallel, double-arm design with a 1:1 allocation ratio. A total of 20 patients undergoing fixed appliance therapy who meet the inclusion and exclusion criteria will be recruited for the study. In the experimental group, 2 ml of injectable platelet-rich fibrin (i-PRF) will be infiltrated into the buccal submucosa, and 1 ml of i-PRF will be infiltrated into the palatal submucosa. No i-PRF injection will be administered in the control group. The rate of canine retraction will be assessed and compared between both the groups at three time points: T0 (baseline), T1 (after 1 month), and T2 ( after 2 months). Additionally, three-dimensional control (transverse, sagittal, and vertical), as well as gingival and periodontal health of the canine and molar teeth, will be evaluated and compared using the Plaque Index, Gingival Index, Modified Sulcular Bleeding Index, and Pocket Depth at T0, T1, and T2. The data will be analyzed using appropriate statistical analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Patients with Class I bimaxillary protrusion and Class II Division 1 malocclusion requiring extraction of maxillary first premolar.
  • Fully erupted permanent dentition (except third molars).
  • Patient with good oral hygiene.

排除标准

  • Pregnant women.
  • Patients with impacted or blocked canine.
  • Patients with systemic disease.
  • Coagulation disorders or being treated with anticoagulants.
  • Patients who had previous orthodontic treatment or had radiographic evidence of bone resorption.

结局指标

主要结局

Rate of canine retraction will compared in the experimental group and control group.

时间窗: Rate of canine retraction will be evaluated at T0 (baseline),T1 (after 1 month) and T2 (after 2 months) intervals.

次要结局

  • 1. To determine and compare the three-dimensional control (transverse, sagittal and vertical) of canine and molar.(2. To determine gingival and periodontal health of canine and molar.)

研究者

发起方
Dr Himanshu Kumar Sah
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Himanshu Kumar Sah

Chhattisgarh Dental College and Research Institute GE Road Sundra Rajnandgaon CG 491441

研究点 (1)

Loading locations...

相似试验