FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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.

 
Close