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
|
|
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
|
|
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
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - REQUEST THROUGH E-MAIL chetana365@gmail.com
- 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.
- 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. |