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临床试验/CTRI/2024/03/063837
CTRI/2024/03/063837尚未招募不适用

Comparative evaluation of skeletal maturity using Middle Phalanx of the third Finger (MP3) , Cervical Vertebral Maturation (CVM) , and Insulin Like Growth Factor 1 ( IGF 1) : An In-Vivo Study

Sakshi Garg1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月15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
30
试验地点
1
主要终点
• To investigate whether blood IGF-1 levels are a reliable predictor of skeletal maturity.

研究概览

简要总结

**AIM:**To evaluate the reliability of IGF-1 for assessing skeletal maturity by comparing IGF-1 levels with MP3 stages and cervical vertebral stages.

OBJECTIVES:

·       To investigate whether blood IGF-1 levels are a reliable predictor of skeletal maturity.

·       To find out a correlation of IGF-1 with stages of cervical vertebral maturation (CVM).

·       To find out a correlation of IGF-1 with stages of the middle phalanx of the third finger (MP3).

Materials:

In this study, following armamentarium will be required:

·       Lateral cephalogram

·       Middle phalanx of middle finger radiograph

·       Insulin like growth factor 1 test in serum

METHODOLOGY

Lateral cephalogram, MP3 radiographs on intraoral periapical films will be obtained for each patient whose growth modification is required and on the same day blood samples will be collected. Serum is separated from the blood samples and are labelled with a patient code (without any mention of patient details such as name, age, sex) and are properly sealed and stored in thermocol box with ice pack (kept between 2 degrees Celsius – 8 degrees Celsius) and will be sent to the laboratory for chemiluminescence immunoassay for determination of IGF-1 levels by a fully automated, two-site chemiluminescent immunoassay. Lateral cephalograms will be taken in natural head position. All the radiographs will be exposed at 80 KVP, 9mA for 1.25 seconds with Ortho pantomography machine of model Kodak CS8000C. The cervical staging technique as described by Baccetti et al will be  used to stage the cervical vertebrae.The intra oral periapical film will be used for radiograph of the middle phalanx of the third finger (MP3) of the right hand. This will be done by placing the hand palm downward on a flat non metallic surface. The middle phalanx of the right middle finger will be placed such that it lied at the center of the x-ray film. The cone of the standard dental x-ray machine (60 KVP and 7mA) will be positioned in light contact with the middle phalanx perpendicular to the dental x-ray film. The exposure time will be set to 0.25 seconds with Ortho pantomography machine of model Kodak CS8000C. For interpretation of MP3 radiograph method introduced by Rajagopal and Kansal will be used.

研究设计

研究类型
Observational

入排标准

年龄范围
8.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Patients with no significant medical history.
  • Patients from daily register to avoid both deliberate and unconscious bias.

排除标准

  • Patient suffering from any serious illness, growth abnormality e.g. craniofacial syndromes, rickets, medical syndromes, bone disease, bone deformities, bleeding disorders.
  • Patients with history of any serious trauma or injury to the face and the hand and wrist region.

结局指标

主要结局

• To investigate whether blood IGF-1 levels are a reliable predictor of skeletal maturity.

时间窗: after the study

• To find out a correlation of IGF-1 with stages of cervical vertebral maturation (CVM).

时间窗: after the study

• To find out a correlation of IGF-1 with stages of the middle phalanx of the third finger (MP3).

时间窗: after the study

次要结局

  • To investigate whether blood IGF-1 levels are a reliable predictor of skeletal maturity.(• To find out a correlation of IGF-1 with stages of cervical vertebral maturation (CVM).)

研究者

发起方
Sakshi Garg
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sakshi Garg

Rajasthan university of health sciences

研究点 (1)

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