CTRI Number |
CTRI/2025/06/089724 [Registered on: 27/06/2025] Trial Registered Prospectively |
Last Modified On: |
26/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Upper Airway Volume in Orthodontic Patients Undergoing Premolar Extraction using MRI |
Scientific Title of Study
|
Evaluation of Upper Airway Volume in Patients undergoing Orthodontic Treatment with Premolar Extraction -An MRI Based Prospective 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 |
Dr Anurag Negi |
Designation |
Professor and Head |
Affiliation |
All India Institute of Medical Sciences ,Bibinagar |
Address |
Department of Dentistry
All India Institute of Medical Sciences ,Bibinagar
Hyderabad Metropolitan Region Telangana
Nalgonda TELANGANA 508126 India |
Phone |
9868604172 |
Fax |
|
Email |
dranurag.aiims@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anurag Negi |
Designation |
Professor and Head |
Affiliation |
All India Institute of Medical Sciences ,Bibinagar |
Address |
Department of Dentistry
All India Institute of Medical Sciences ,Bibinagar
Hyderabad Metropolitan Region Telangana
Nalgonda TELANGANA 508126 India |
Phone |
9868604172 |
Fax |
|
Email |
dranurag.aiims@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sakshi Katyal |
Designation |
Senior Resident |
Affiliation |
All India Institute of Medical Sciences ,Bibinagar |
Address |
Department of Dentistry
All India Institute of Medical Sciences ,Bibinagar
Hyderabad Metropolitan Region, Telangana
Nalgonda TELANGANA 508126 India |
Phone |
9815964046 |
Fax |
|
Email |
sakshidr.aiimsbbn@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical Sciences Bibinagar,
Hyderabad Metropolitan Region,
Telangana,
508126,
for infrastructure support |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences Bibinagar ,Hyderabad |
Address |
Room no 4, ground floor, AYUSH Building, Department of Dentistry, All India Institute of Medical Sciences ,Bibinagar , Hyderabad Metropolitan Region,Telangana
508126
|
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 Sabi S Kumar |
All India Institute of Medical Sciences, Bibinagar, Telangana |
Department of Dentistry,
Room no 4,
Ground floor, AYUSH Building, India, PIN 508126,
Hyderabad TELANGANA |
6238748362
drsabiaiimsbbnagar@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee of All India Institute of Medical Sciences (AIIMS) Bibinagar |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
19.00 Year(s) |
Age To |
28.00 Year(s) |
Gender |
Both |
Details |
Bimaxillary protrusion (Upper central incisor to Sella Nasion plane to 120 to 135 degree)
Age ranging from 19 to 28 years
All teeth should be present till the second molar
Average growth pattern (Angle Sella Nasion to Gonion Gnathion plane 28 degree to 35 degree)
Participants (or Guardian,if minor) must provide written informed consent
Body mass index (BMI) within normal limits (18.5 to 23.9kg-m2)
|
|
ExclusionCriteria |
Details |
1) Children/Individuals less than 18 years.
2) Any history of adenoidectomy/tonsillectomy, pharyngeal pathology, nasal
3) Obstruction, snoring, obstructive sleep apnea, claustrophobia, previous orthodontic/orthognathic treatment
4) Dental prosthesis that may have caused safety problems during an MRI scan /pacemaker.
5) Patients not indicated for surgical procedures such as extraction (Bleeding or clotting disorders)
6) Supernumerary or missing teeth till second molar.
7) Periodontally compromised patients.
8) Any systemic disorders, syndromic conditions.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Three-dimensionally assess change in airway volume following orthodontic treatment by extraction mechanics |
Baseline and 18 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To correlate the change in arch perimeter with the airway volume
|
Baseline & 18 months |
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
11/07/2025 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
This study aims to evaluate the changes in airway volume using MRI following orthodontic treatment with premolar extraction in Bimaxillary protrusion patients.A total of n=32 patients in the age group of 19-28 yrs with Bimaxillary protrusion indicated for fixed orthodontic treatment with extraction of all the first four premolar teeth will be recruited. Pre-treatment intra-extraoral photographs, study models, Magnetic Resonance Imaging (MRI) will be recorded. MRI will be taken in two stages using 3-Tesla Magnetom VIDA system pretreatment before bonding (T0) and immediately after debonding (T1) to assess the volumetric changes in airway and to correlate with arch perimeter. T1 weighted (T1-w) images will be acquired. The standardised procedure will be followed by stabilising head with foam pads keeping Frankfort horizontal plane (FHP) perpendicular to floor in awake patients with supine position and head in neutral anatomical position. Participants will be instructed to breathe normally through their nose, rest their tongue on the back of the front teeth with teeth lightly touching, and refrain from swallowing. Midsagittal and axial views of airway (T1-w images) will be analysed though software Syngo.via siemens (Siemens Medical Solutions USA). The landmarks identification will be done by the senior orthodontist. Extraction of all first premolars willl be done followed by placement of 0.022 ×0.028-inch slot MBT bracket for the fixed appliance therapy. Interradicular titanium miniscrews ( 1.8x8mm) will be inserted immediately after extraction between second premolar and first molar in both the jaws to preventing mesial drift of posterior teeth during levelling and alignment. Post alignment retraction of anterior teeth will be done by enmass retraction using NiTi closed coil spring (9mm with 250 gm force) by anchorage from MS1.The force range of 250-300grams will be used during the entire course of the procedure. Finishing and detailing will be done till 0.021x0.025 TMA wire. Post-treatment MRI of patient will be recorded immediately after debonding and before placement of fixed retainers.Post-treatment records will be obtained.The data will be analyzed using SPSS v29. The inter-operator and intra-operator reliability assessment will be calculated using inter-class coefficient. Normality of data will be assessed using Shapiro-wilk test. Descriptive statistics will be calculated based on population parameters. Pre (T0) and post-treatment (T1) changes in upper airway volume will be analysed with Paired t-test (Mean + SD) and Post-hoc test will be conducted to evaluate for any co-relation with change in arch-length. |