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CTRI Number  CTRI/2023/04/051686 [Registered on: 17/04/2023] Trial Registered Prospectively
Last Modified On: 18/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of conventional and miniscrew-assisted rapid palatal expansion 
Scientific Title of Study   Comparative evaluation of the skeletal and dentoalveolar effects of conventional and miniscrew-assisted rapid palatal expansion: A Randomized Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivek kumar Thakur 
Designation  Graded Specialist Orthodontics 
Affiliation  Army Dental Centre Research and Referral 
Address  Army Dental Centre R and R Hospital, near Subroto park. Delhi Cantt. New Delhi 110010

New Delhi
DELHI
110010
India 
Phone  9765160641  
Fax    
Email  drvivekortho31@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek kumar Thakur 
Designation  Graded Specialist Orthodontics 
Affiliation  Army Dental Centre Research and Referral 
Address  Army Dental Centre R and R Hospital, near Subroto park. Delhi Cantt. New Delhi 110010


DELHI
110010
India 
Phone  9765160641  
Fax    
Email  drvivekortho31@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vivek kumar Thakur 
Designation  Graded Specialist Orthodontics 
Affiliation  Army Dental Centre Research and Referral 
Address  Army Dental Centre R and R Hospital, near Subroto park. Delhi Cantt. New Delhi 110010


DELHI
110010
India 
Phone  9765160641  
Fax    
Email  drvivekortho31@gmail.com  
 
Source of Monetary or Material Support  
Government funding agency (AFMRC project) 
 
Primary Sponsor  
Name  Armed Forces Medical Research Committee 
Address  Office of the DGAFMS/DG-3B, Ministry of Defence, Pin- 908713 c/o 56 APO 
Type of Sponsor  Government funding agency 
 
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 
Lt Col Vivek Kumar Thakur  Surgery 6, New Orthodontic Block, Army Dental Centre R and R, Dhaula khuan, Delhi Cantt.  Army Dental Centre R & R, Dhaula khuan, Delhi Cantt.
New Delhi
DELHI 
9765160641

thakurvivek13@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  
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  1. conventional maxillary expansion appliances  Conventional maxillary expansion appliances- (a) Banded Hyrax appliance (b) Bonded Hyrax appliance. The total duration of rapid maxillary expansion intervention varies between 4 to 6 months, including the active phase of 2-4 weeks followed by the retention phase. 
Comparator Agent  2. Mini implant assisted rapid palatal expansion (MARPE).  with MARPE appliance also the total duration of rapid maxillary expansion intervention varies between 4 to 6 months, including the active phase of 2-4 weeks followed by the retention phase. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Transverse maxillary hypoplasia or presence of posterior crossbite 
 
ExclusionCriteria 
Details  1. Previous h/o Orthodontic Treatment
2. Severe systemic illness
3. Syndromic and CL & P cases
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The skeletal expansion achieved in milimeters.
2. The dentoalveolar expansion achieved in milimeters.
 
T0 - Pretreatment
T1 - post-expansion (after consolidation and expansion appliance removal)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the amount of vertical changes produced by different rapid maxillary expansion appliances studied.

2. To determine the mandibular rotation produced by different rapid maxillary expansion appliances studied.

 
T0 - Pretreatment
T1 - post-expansion (after consolidation and expansion appliance removal)
 
 
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)   02/05/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Management of skeletal discrepancies in the transverse plane requires early intervention. Rapid Maxillary Expansion (RME) occupies a unique niche in Orthodontics in managing transverse discrepancies. Multiple options are available in the literature for correcting the discrepancy in various age groups depending upon the tenacity of the mid-palatine and circummaxillary sutures.

           Biomechanically RME induces displacement and stress patterns in the craniofacial skeleton in response to forces applied which are clinically manifested as desirable and undesirable responses. Different types of RME devices and techniques have been discussed in literature such as Tooth Borne appliances and Bone borne appliances using Simple Removable Plates, Hyrax Screws, Hass Screw, Bonded Acrylic appliances, Banded Appliances with screws and Bone borne miniscrew-assisted rapid palatal expansion (MARPE) appliance. Skeletal and Dental changes are observed depending on the type of appliance, its area of operation and the site of placement.

In the presently available literature, there are lacunae in comparative evidence between both conventional and MARPE appliances. Hence the study shall evaluate the skeletal and dentoalveolar effects of conventional and miniscrew-assisted rapid palatal expansion. This study shall provide evidence and enable the clinician to choose between the two appliances, considering the three-dimensional effects of these appliances.

 
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