| CTRI Number |
CTRI/2024/03/063837 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing skeletal maturity index indicators - cervical vertebral maturation(CVM) and middle phalanx of the third finger (MP3) and insulin like growth factor 1(IGF 1) |
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Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Garg |
| Designation |
post graduate student |
| Affiliation |
Rajasthan university of health sciences |
| Address |
Department of orthodontics and dentofacial orthopedics, room number 3, surendera dental college and research institute, HH gardens, power house road
Ganganagar
RAJASTHAN
335001
India |
| Phone |
07973414841 |
| Fax |
|
| Email |
dr.sakshigarg0105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Eenal Bhambri |
| Designation |
professor and head |
| Affiliation |
Rajasthan university of health sciences |
| Address |
surendera dental college and research institute, HH gardens, power house road
Ganganagar
RAJASTHAN
335001
India |
| Phone |
8769829700 |
| Fax |
|
| Email |
dreenal700@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sakshi garg |
| Designation |
post graduate student |
| Affiliation |
Rajasthan university of health sciences |
| Address |
department of orthodontics and dentofacial orthopedics, room number 3, surendera dental college and research institute, HH gardens, power house road
Ganganagar
RAJASTHAN
335001
India |
| Phone |
07973414841 |
| Fax |
|
| Email |
dr.sakshigarg0105@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS , Room number 3, a block SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE, Sri Ganganagar, rajasthan 335001 |
|
|
Primary Sponsor
|
| Name |
Sakshi Garg |
| Address |
Surendera dental college and research institute , sri ganganagar, rajasthan 335001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sakshi Garg |
Surendera dental college and research institute , sri ganganagar, rajasthan 335001 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sakshi Garg |
surendera dental college and research institute |
department of orthodontics and dentofacial orthopedics, room number 3 , surendera dental college and research institute, HH gardens, power house road
Ganganagar
RAJASTHAN |
07973414841
dr.sakshigarg0105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PATIENT OPTING REGULAR ORTHODONTIC TREATMENT |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Patients with no significant medical history.
Patients from daily register to avoid both deliberate and unconscious bias.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• 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).
|
after the study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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).
|
after the study |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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.
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