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CTRI Number  CTRI/2024/10/075097 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Compare Two Different Designs of Maxillary Skeletal Expanders 
Scientific Title of Study   Comparative Evaluation of the Skeletal, Dentoalveolar and Dental Changes Following Maxillary Skeletal Expansion Using Expanders of Two Different Designs –A Randomized Clinical Trial 
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 Shobha Sundareswaran 
Designation  professor 
Affiliation  KMCT Dental College, Kozhikode 
Address  Department of Orthodontics & Dentofacial Orthopedics KMCT Dental College Kozhikode Kerala

Kozhikode
KERALA
673602
India 
Phone  9447067245  
Fax    
Email  drshobhakumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shobha Sundareswaran 
Designation  Professor 
Affiliation  KMCT Dental College, Kozhikode 
Address  Department of Orthodontics & Dentofacial Orthopedics KMCT Dental College Kozhikode Kerala

Kozhikode
KERALA
673602
India 
Phone  9447067245  
Fax    
Email  drshobhakumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shobha Sundareswaran 
Designation  Professor 
Affiliation  KMCT Dental College, Kozhikode 
Address  Department of Orthodontics & Dentofacial Orthopedics KMCT Dental College Kozhikode Kerala

Kozhikode
KERALA
673602
India 
Phone  9447067245  
Fax    
Email  drshobhakumar@gmail.com  
 
Source of Monetary or Material Support  
KMCT Dental College Kozhikode Kerala Pin code :673602 
 
Primary Sponsor  
Name  Dr Bini KK  
Address  KMCT DENTAL COLLEGE MANASSERY , MUKKAM KOZHIKODE PIN-673602 kerala 
Type of Sponsor  Other [self funded] 
 
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 BINI K K  KMCT Dental College  5th floor, Department of Orthodontics & Dentofacial Orthopedics
Kozhikode
KERALA 		 9494323869

biniseemanthini@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMCT DC ETHICS COMMITTEE  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, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  FAVEX -maxillary skeletal expansion  maxillary skeletal expansion using favex 
Intervention  MSE-Maxillary Skeletal Expansion  Maxillary skeletal expansion using MSE for a period of one month in each case 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  (1)presence of transverse skeletal maxillary deficiency with or without the presence of
posterior crossbite as described by Penn CBCT transverse analysis (2)incomplete
radiographic ossification of the mid palatal suture according to Angelieri’s classification
(3) bilateral presence of first and second upper premolars and first upper molars . 
 
ExclusionCriteria 
Details  (1)Those with any craniofacial irregularities, and any bone defects, (2) those who have
received previous orthodontic / orthopedic treatment (3) patients with systemic and
periodontal disease (4) those with a portion of suture where fusion has occurred ( stage E in
accordance with Angilieri’s classification) and with no low- density spaces along the suture. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Amount of Maxillary Skeletal Expansion Assessed by Change in Midpalatal Sutural Width   Three months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in Nasal Width
2.Change in Alveolar Bone Thickness
3.Change in Buccal
Alveolar Bone Crest Level
4.Change in Dental Inclination 		 Three months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   01/11/2024 
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="0"
Months="3"
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 - All of the individual participant data collected during the trial, after de-identification.

  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 - 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 - Proposals should be directed to [biniseemanthini@gmail.com].

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 01-01-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The aim of the study is to comparatively evaluate skeletal, dental and dentoalveolar changes after maxillary skeletal expansion using two different designs of tooth bone-borne expanders in adolescent patients by Cone beam computed tomography (CBCT). 24 patients will be recruited based on inclusion and  exclusion  criteria and  randomly allocated to intervention/ comparator groups. After achieving maxillary skeletal expansion, primary and secondary outcomes will be evaluated. 
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