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CTRI Number  CTRI/2023/07/054684 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 28/06/2023
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 evaluate the effects of ultrasound in bone formation after upper jaw expansion through radiograph 
Scientific Title of Study   Evaluation of the role of Low-Intensity Pulsed Ultrasound on Midpalatal sutural bone formation after rapid palatal expansion through Cone Beam Computed Tomography : A Pilot Randomised Controlled 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 MeenasundariS 
Designation  Junior resident 
Affiliation  Centre for Dental Education and Research 
Address  4th floor - Division of Orthodontics and Dentofacial Deformities CDER,AIIMS Block D2 Ansari nagar east New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  meena96sundariq@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ritu Duggal 
Designation  Chief and HOD 
Affiliation  Centre for Dental Education and Research 
Address  Room No 401, 4th floor- Division of Orthodontics and Dentofacial Deformities CDER,AIIMS Block D2 Ansari nagar east New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  rituduggal@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ritu Duggal 
Designation  Chief and HOD 
Affiliation  Centre for Dental Education and Research 
Address  Room No 401, 4th floor- Division of Orthodontics and Dentofacial Deformities CDER,AIIMS Block D2 Ansari nagar east New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  rituduggal@rediffmail.com  
 
Source of Monetary or Material Support  
Dr. Meenasundari 
 
Primary Sponsor  
Name  Meenasundari 
Address  4th floor Division of Orthodontics and dentofacial deformities CDER Block D2 Ansari nagar east New Delhi 110029 
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 Meenasundari  Centre for Dental Education and Research   4th floor - Division of Orthodontics and Dentofacial Deformities Block D2 Ansari nagar east New Delhi - 110029
South
DELHI 		 9500573508

meena96sundariq@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M260||Major anomalies of jaw size,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Rapid maxillary expansion without LIPUS in post expansion period 
Intervention  Low-Intensity Pulsed Ultrasound  Rapid maxillary expansion with LIPUS in post expansion period. It operates at 1.5 MHz frequency frequency in a pulsed wave - 100,1000Hz, low intensity - 30mW/cm2, 60mW/cm2 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Patients with maxillary skeletal posterior cross bite
Patients with informed consent 
 
ExclusionCriteria 
Details  Patients with cleft lip and or palate and syndromic patients
Patients with history of trauma or fracture in the maxillofacial region
Patients with history of any systemic bone disorders.
Medically compromised patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
comparison of Radiographic bone density preoperative and after rapid palatal expansion in intervention and control group  preoperatively and 3 months after expansion  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   07/08/2023 
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="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Maxillary transverse discrepancy is one of the most pervasive skeletal problems in the craniofacial region. For patients with maxillary constriction and transverse , Rapid maxillary expansion is a commonly performed treatment approach that promotes opening of mid-palatal suture. However, it has a high release rate. To avoid relapse, qualifies bone organization required for maintenance of the expanded maxillary sutures. Therefore, the concept of accelerating new bone formation was expected to improve the stability of the expanded maxilla and shorten the retention period.
Low intensity pulsed ultrasound is a medium frequency ultrasound with low intensity. It has been used extensively in the field of orthopaedic surgery to improve fracture healing. The purpose of the study is to evaluate the effects of Low-Intensity Pulsed Ultrasound on enhancing the mid-palatal sutural bone formation after rapid maxillary expansion appliance which thereby shorten the retention period and improve the stability of expansion.
 
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