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临床试验/CTRI/2023/04/051626
CTRI/2023/04/051626尚未招募2 期

Effect of Platelet-Rich Plasma on the rate of Orthodontic Tooth Movement and on the Biomarkers present in Gingival Crevicular Fluid – An In-Vivo Study.

Dr DY Patil Dental College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年4月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
INCREASED RATE OF TTOTH MOVEMENT BY ATLEAST 1.5% THAN NORMAL DUE TO THE EFFECT OF PRP

研究概览

简要总结

Orthodontic Treatment requires the use of brackets and wires tofacilitate tooth movement and bring about alignment. This procedure takes anaverage of about 24 months and sometimes more. There have been various studiesto reduce the treatment time and many methods have been put forth to bringabout faster tooth movement. These include acceleration of orthodontic toothmovement by use of ultrasonic vibrations, photobiomodulation, low level lasertherapy, and use of pharmaceutical approach. One of the recently used localagents to accelerate the rate of orthodontic tooth movement is platelet-richplasma (PRP). PRP is defined as an autologous concentration of platelets in aminute volume of plasma. The alpha granules in the platelets are the mostabundant secretory granules. They contain numerous proteins, including growthfactors and chemokines, which are crucial for primary hemostasis and woundhealing. Additionally, the rate of orthodontic movement can be studied throughthe biomarkers present in the Gingival Crevicular Fluid(GCF) which is agingival exudate. Using the knowledge of the biochemical changes taking placein the GCF following the use of PRP, we can attempt to synthetically alter thetooth movement and accelerate our treatment time.

Novelty: We plan to use the information in accelerating orthodontic treatmenttime in adults so that more adult patients can seek orthodontic treatment.

Objectives: The study’s objective is to find the effect of PRP on therate of tooth movement and on the biomarkers that are present in GCF.

Methods: The method would include injecting a small amount of PRP which would beprepared from the patient’s own blood, into the desired site in the mouth.Later, GCF samples would be collected from these sites at designated time intervalsto study the effect of PRP on the biomarkers in GCF.

Expected outcome:

1)Intervention side tooth movement will be accelerated.

2)Identification of biomarkers responsible for enhanced tooth movement.

  1. Isolated Biomarkers for faster tooth movement therapy.

研究设计

研究类型
Interventional
分配方式
Adaptive randomization, such as minimization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
16.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 20 participants between the ages of 16 and 35 who have a full complement of teeth and good periodontal health and no severe medical history or metabolic bone disease will be chosen for the study.
  • The selected subjects either had bimaxillary protrusion or Class II Division I malocclusion, undergoing orthodontic treatment and requiring extraction of 1st premolars.

排除标准

  • Exclusion criteria for the trial will be those with periodontal diseases/poor oral hygiene, patients with autoimmune diseases, pregnancy, and lactation and those on medication (e.g. antibiotics, antihistamines, cortisone, hormones, and any other medication that may interfere with the inflammatory process or adversely affect the periodontium) and syndromic patients.

结局指标

主要结局

INCREASED RATE OF TTOTH MOVEMENT BY ATLEAST 1.5% THAN NORMAL DUE TO THE EFFECT OF PRP

时间窗: We intend to check the amount of tooth movement at 1, 2 and 3 months time interval

次要结局

  • EFFECT OF BIOMARKERS IN THE GCF COLLECTED DURING THE 3 MONTHS OF TRIAL PERIOD(3 MONTHS)

研究者

发起方
Dr DY Patil Dental College
申办方类型
Research institution and hospital

研究点 (1)

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