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CTRI Number  CTRI/2025/05/086693 [Registered on: 09/05/2025] Trial Registered Prospectively
Last Modified On: 10/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A Study on the Impact of Two Orthodontic Treatments on Airway in Children with Early Class III Malocclusion 
Scientific Title of Study   A comparative cephalometric evaluation of changes in the upper airway among patients with developing Class III malocclusion treated using two interceptive orthodontic appliances. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RENJINI KS 
Designation  PG student 
Affiliation  MES Dental college and Hospital 
Address  Karachuthara house Elamkunnapuzha p o
Department of Orthodontics MES Dental college and Hospital Palachode p o Kolathur Via Perinthalmanna Pin 679338
Malappuram
KERALA
682503
India 
Phone  09645345661  
Fax    
Email  renjini.ks8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MOHAMMAD SHALOOB 
Designation  Professor 
Affiliation  MES Dental college 
Address  MES Dental college
Department of Orthodontics Room no 7 MES Dental college and Hospital Palachode p o Kolathur Via Perinthalmanna Pin 679338
Malappuram
KERALA
679321
India 
Phone  9746277277  
Fax    
Email  shaloobdr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr mohammad shaloob  
Designation  professor  
Affiliation  MES DENTAL COLLAGE 
Address  MES DENTAL COLLEGE
Department of Orthodontics Room no 7 MES Dental college and Hospital Palachode p o Kolathur Via Perinthalmanna Pin 679338
Malappuram
KERALA
979321
India 
Phone  9746277277  
Fax    
Email  drshaloob@gmail.com  
 
Source of Monetary or Material Support  
MES Dental college and Hospital Palachode p o Kolathur Via Perinthalmanna Pin 679338 
 
Primary Sponsor  
Name  MES Dental college and Hospital 
Address  MES Dental college and Hospital Department of Orthodontics Room no 7 Palachode p o Kolathur Via Perinthalmanna Pin 679338 
Type of Sponsor  Other [Private Dental College] 
 
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 Renjini KS  MES Dental college and Hospital  MES Dental collage and hospital Department of orthodontics Room no 7 Palachod p o Kolathur Perunthalmanna Malappuram
Malappuram
KERALA 
09645345661

renjini.ks8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUSION ETHICS COMMITTEE MES Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  RME Facemask  Rapid palatal expansion and facemask with expected duration of 12 months 
Comparator Agent  SEC III  The SEC III protocol includes two occlusal acrylic Splints combined with Class III elastics and chin cup with expected duration of 12 months 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Patients with developing skeletal Class III Malocclusion will be included in the study
Angles class III molar and canine relationship with anterior and posterior crossbite
Absence of CO CR discrepancy
Wits appraisal of 2 mm
Skeletal maturation CVMI 2&3 stage
 
 
ExclusionCriteria 
Details  Patients with facial asymmetry
Patients with CVMI stage 4 onward
Patients with a history of previous facial trauma tonsillectomy maxillofacial surgery adenoidectomy
Patients with congenital syndromes
History of metabolic disorders
Presence of periodontitis
History of previous orthodontic orthopaedic treatment
Presence of decayed molar teeth
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate any changes in the upper airway while using the modified SEC III appliance and RME reverse pull headgear in patients with developing skeletal class III malocclusion  Pretreatment taken within 1 week before appliance placement Posttreatment records taken after 10 weeks upon completion of active phase

 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate changes in the upper airway in male & female patients with developing skeletal Class III malocclusion while using the modified SEC III appliance & rapid maxillary expansion with reverse pull headgear  Pretreatment taken within 1 week before appliance placement Posttreatment records taken after 10 weeks upon completion of active phase

 
 
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)   21/05/2025 
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 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 - 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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [renjini.ks8@gmail.com].

  6. For how long will this data be available start date provided 21-05-2025 and end date provided 21-10-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

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

TITLE

Comparative cephalometric evaluation of changes in the upper airway among patients with developing class III malocclusion treated using two interceptive orthodontic appliances.

 INTRODUCTION, RATIONALE, RELEVANCE

Breathing is one of the primary essential processes of the human body, and it is facilitated by the upper airway. Orthodontists have always been interested in investigating the upper airway, with the primary goal being to explain the relationship between pharyngal features and the growth and development of the craniofacial complex. Predisposing factors that block the upper airway include obstructive processes of morphologic, physiologic, or pathologic nature, such as tumors, polyps, allergic and chronic rhinitis, infections, irritant environmental factors, congenital nasal deformities, tonsil, and hypertrophy etc. When that occurs, a functional imbalance leads to an oral breathing pattern that might modify the shapes of the dental arch and the face morphology, ultimately resulting in a malocclusion.

One of the most difficult malocclusions to treat is skeletal Class III malocclusion. Studies on the etiology of Class III malocclusion have shown that 32–63% of patients with a skeletal Class III malocclusion have a retruded maxilla or a combination of a retruded maxilla and excessive mandibular growth. A mixture of various treatment methods, such as chin cups, SEC III appliance, skeletal anchorage systems, removable functional appliances, fixed appliances, and removable appliances are possible approaches. The size of the maxilla and the mandible has been shown to correlate with the pharyngeal airway dimensions. A skeletal change that can occur from the orthopedic treatment of Class III malocclusion is the alteration of the size of the airway. The primary effects of correction with the SEC III appliance were mainly skeletal and slightly dentoalveolar in nature with the greatest impact on maxillary and mandibular position, with significant amount of sagittal advancement in maxilla. The RME- reverse pull headgear induces a significant increase of the inter maxillary vertical relationships.

Airway dimensions can be assessed using different imaging techniques, one of which is lateral cephalometric radiography. Lateral cephalograms are obtained routinely as a part of orthodontic diagnostic procedures.   The accuracy of airway measurements from lateral cephalograms, cone-beam computed tomographic (CBCT) lateral reconstructions, and CBCT axial planes, airway linear measurements are reliable, with both lateral cephalograms and CBCT reconstruction. Cephalometric analysis allows the measurement of the airway dimensions without exposing the patient to additional radiation.In this study pre-and post-treatment lateral cephalometric radiographs of 30 patients who will be treated using two interceptive orthodontic appliances in developing class III malocclusion will be used. Group I patients will be treated using a reverse pull headgear after rapid maxillary expansion (RME).Group II patients will be treated using the modified SEC III appliance having two occlusal splints with Class III elastics, RME, and a chin cup as part of it. 

NOVELTY

Currently studies evaluating the impact of airway dimensions in patients receiving RME -reverse pull headgear/ The modified SEC III appliance treatment for developing skeletal class III malocclusion are not available in the literature and there is a lacuna in the literature. So, the purpose of this study is to assess whether there are any appreciable variations in the airway dimensions when employing two interceptive orthodontic appliances—the modified SEC III appliance and RME -reverse pull headgear in patients with developing skeletal class III malocclusion reporting to the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College Perinthalmanna.

  RESEARCH QUESTION

Will there be a noticeable difference in airway dimensions between the two interceptive orthodontic appliances (the modified SEC III appliance and RME -reverse pull headgear) in patients with developing skeletal class III malocclusion who are reporting to the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College, from May 31, 2024 to December 31, 2025?

AIM

To evaluate any changes in the upper airway while using the modified SEC III appliance and RME -reverse pull headgear in patients with developing skeletal class III malocclusion who are reporting to the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College Perinthalmanna.

INCLUSION CRITERIA

Patients with developing skeletal Class III Malocclusion will be included in the study

Angles class III molar and canine relationship with anterior and posterior crossbite

Absence of CO CR discrepancy

Wits appraisal of 2 mm

Skeletal maturation CVMI 2&3 stage

EXCLUSION CRITERIA

Patients with facial asymmetry

Patients with CVMI stage 4 onward

Patients with a history of previous facial trauma tonsillectomy maxillofacial surgery  adenoidectomy

Patients with congenital syndromes

History of metabolic disorders

Presence of periodontitis

History of previous orthodontic orthopaedic treatment

Presence of decayed molar teeth


 
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