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CTRI Number  CTRI/2021/04/033170 [Registered on: 27/04/2021] Trial Registered Prospectively
Last Modified On: 07/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   EFFECT OF BODY FAT PERCENTAGE AND BODY MASS INDEX ON ORTHODONTIC TOOTH MOVEMENT 
Scientific Title of Study   ASSESSMENT OF THE IMPACT OF BODY FAT PERCENTAGE AND BODY MASS INDEX ON ORTHODONTIC TOOTH MOVEMENT: A PROSPECTIVE CLINICAL STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHETANA V HIREMATH 
Designation  POST GRADUATE STUDENT DEPARTMENT OF ORTHODONTICS 
Affiliation  SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS , ROOM NO-7, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR, HASSAN
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS , ROOM NO-7, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR, HASSAN
Hassan
KARNATAKA
573202
India 
Phone  9480799162  
Fax    
Email  chetana365@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  REJI ABRAHAM 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT OF ORTHODONTICS 
Affiliation  SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS , ROOM NO-7, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR, HASSAN
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS , ROOM NO-7, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR, HASSAN
Hassan
KARNATAKA
573202
India 
Phone  9947357788  
Fax    
Email  rejiabm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  REJI ABRAHAM 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT OF ORTHODONTICS 
Affiliation  SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS , ROOM NO-7, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR, HASSAN
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS , ROOM NO-7, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR, HASSAN
Hassan
KARNATAKA
573202
India 
Phone  9947357788  
Fax    
Email  rejiabm@gmail.com  
 
Source of Monetary or Material Support  
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR, HASSAN 
 
Primary Sponsor  
Name  SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL 
Address  SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR, HASSAN, KARNATAKA 573202 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 REJI ABRAHAM  SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, HASSAN  ROOM NO-7 ,DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS.
Hassan
KARNATAKA 
9947357788

rejiabm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  TO ASSESS ORTHODONTIC TOOTH MOVEMENT IN PATIENTS IN WHOM UPPER 1ST PREMOLARS ARE EXTRACTED  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Subjects who are willing to participate in the study.
2. Subjects who will undergo fixed orthodontic treatment with Pre-adjusted Edgewise Appliance (PEA) with 0.022ʺslot MBT prescription.
3. Subjects in the age range of 15-35 years.
4. Normal weight subjects with BMI (18.5Kg/m2 or more and less than 25Kg/m2) and overweight or
obese subjects with BMI (25Kg/m2 or more).
5. Subjects with normal Body Fat percentage’s (BF%) 10 to < than 20% for males and 20 to < than
30% for females and high to very high Body Fat percentage’s (BF%) 20% or more for males and
30% or more for females.
6. Subjects who will be entering the retraction stage after completion of the leveling and alignment (Ist phase).
7. Subjects in whom maxillary 1st premolar extraction will be indicated and who will have at least 5mm of space for en masse retraction of maxillary anteriors.

 
 
ExclusionCriteria 
Details  1. Previous history of orthodontic treatment.
2. Presence of any syndromes or systemic diseases.
3. Presence of any signs and symptoms of periodontal disease.
4. Long term use of phenytoin sodium, cyclosporin, anti-inflammatory drugs, steroids and calcium channel blockers.
5. Poor oral hygiene for more than 2 visits.
6. Smoking and other habits such as chewing pan.
7. Pregnant and lactating women.
8. Subjects who are on statins or lipid lowering agents
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
EFFECT OF HIGH OR LOW BODY FAT PERCENTAGE AND BODY MASS INDEX ON ORTHODONTIC TOOTH MOVEMENT  THREE MONTHS FROM THE START OF EN MASSE RETRACTION OF MAXILLARY ANTERIOR TEETH 
 
Secondary Outcome  
Outcome  TimePoints 
TO COMPARE THE EFFECT OF BODY FAT PERCENTAGE ON ORTHODONTIC TOOTH MOVEMENT AND BODY MASS INDEX ON ORTHODONTIC TOOTH MOVEMENT  THREE MONTHS FROM THE START OF EN MASSE RETRACTION OF MAXILLARY ANTERIOR TEETH 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/05/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  REQUEST THROUGH E-MAIL chetana365@gmail.com

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2075?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Orthodontic tooth movement is defined as “the result of a biologic response to interference in the physiologic equilibrium of the dentofacial complex by an externally applied force.” Numerous factors, such as age, drug consumption, diet, several systemic conditions and other intrinsic genetic factors are considered to influence the rate of orthodontic tooth movement. Continuous efforts are being made to find out the factors influencing orthodontic tooth movement. Body Mass Index (BMI) is one of the factors which is thought to influence orthodontic tooth movement. Many studies have been conducted to correlate Body Mass Index (BMI) with orthodontic tooth movement, but the results were either inconclusive or debatable. This was mainly due to the inappropriate methodologies applied in these studies. Another possible reason could be that; in most of these studies, the Body Mass Index (BMI) was used as a reference to differentiate normal and obese individuals. Although the Body Mass Index (BMI, kg/m2) is widely used as a proxy measure of adiposity, it is a measure of excess weight relative to height, rather than excess body fat. Values of body weight adjusted to height in square mm is BMI i.e. (BMI; in kg/m2). BMI values in excess of 25 and 30 are considered to indicate overweight and obesity respectively. A BMI value of 18.5 to 24.9 is considered to be normal. The main assumption of BMI guidelines is that body mass divided by height in m2, is closely associated with body fatness. However, some individuals who are overweight may not be overfat (e.g., bodybuilders). Others have BMI’s within the normal range but may have a high percentage of their body weight as fat.  Hence the drawbacks of these studies were that they only considered BMI as a measure of adiposity to differentiate between obese and normal individuals and did not consider Body Fat percentage (BF%) levels of the studied individuals. Increase in Body Fat percentage (BF%) levels has been correlated with the increase in serum leptin levels. Studies also have found that the leptin which is available in saliva controls bone metabolism which in turn has an inverse effect on the orthodontic tooth movement. Hence the Body Fat percentage (BF%) levels could indirectly play a vital role in the orthodontic tooth movement. So far in the scientific literature, no studies have been reported evaluating the relationship of Body Fat percentage (BF%) on orthodontic tooth movement. Hence with the above background, this study is designed to assess the relationship between BMI, Body Fat percentage (BF%) levels and orthodontic tooth movement.

 
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