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CTRI Number  CTRI/2024/04/066366 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 04/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing airway changes in patients with cleft lip and palate in early age when treated with aligners and expanders. 
Scientific Title of Study   Comparative Assessment of Volumetric Airway Changes in Unilateral Cleft Lip and Palate patients in Mixed Dentition treated for Maxillary Expansion using Aligners and Ni-Ti palatal expander: A 3-D CBCT 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 Riddhi Bansal 
Designation  Post gradute student 
Affiliation  Manav Rachna Dental College 
Address  Manav Rachna Dental College School of Dental Sciences MRIIRS Department no 3 Ground floor Surajkund Road Faridabad HARYANA 121003 India

Faridabad
HARYANA
121003
India 
Phone  8827269156  
Fax    
Email  bansalriddhi4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Puneet Batra 
Designation  Principal (Prof) HOD 
Affiliation  Manav Rachna Dental College 
Address  Manav Rachna Dental College School of Dental Sciences MRIIRS Department no 3 Ground floor Surajkund Road Faridabad HARYANA 121003 India

Faridabad
HARYANA
121003
India 
Phone  9810335961  
Fax    
Email  drpuneetbatra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Riddhi Bansal 
Designation  Post gradute 
Affiliation  Manav Rachna Dental College 
Address  Manav Rachna Dental College School of Dental Sciences MRIIRS Department no 3 Ground floor Surajkund Road Faridabad HARYANA 121003 India

Faridabad
HARYANA
121003
India 
Phone  8827269156  
Fax    
Email  bansalriddhi4@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Manav Rachna Dental College School of Dental Sciences MRIIRS Department no 3 Ground Floor Surajkund Road Faridabad Haryana India Pin- 121003 
 
Primary Sponsor  
Name  Dr. Riddhi Bansal 
Address  Manav Rachna Dental College School of Dental Sciences MRIIRS Department no 3 Ground floor Surajkund Road Faridabad 
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 Riddhi Bansal  MANAV RACHNA DENTAL COLLEGE  Department of Orthodontics and Dentofacial Orthopedics Department no 3 Ground floor Surajkund Road Faridabad
Faridabad
HARYANA 
8827269156

bansalriddhi4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manav Rachna Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K008||Other disorders of tooth development,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aligners  Maxillary expansion will be done with Aligners till the arch is expanded and crossbite is corrected and assessment of volumetric airway changes will be done immediately after the expansion is achieved at T1 (after expansion) 
Intervention  NiTi palatal expander  Maxillary expansion will be done with NiTi palatal expander till complete dentoalveolar expansion is achieved and crossbite is corrected and assessment of volumetric airway changes will be done after the desired expansion is achieved at the time of removal of expansion appliance at T1 (after expansion) 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Complete unilateral cleft lip and palate
Both sexes
Age group from 7 years to 11 years
 
 
ExclusionCriteria 
Details  Syndromic cleft lip and palate patients
Individuals with systemic diseases affecting bone density
Erupted permanent canines
Bilateral cleft lip and palate patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the volumetric airway changes after maxillary expansion using aligners and Ni-Ti palatal expander in unilateral cleft lip and palate patients in mixed dentition palate patients in mixed dentition  T0- Before expansion
T1- After expansion 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate changes in questionnaire based assessment of OSA risk in UCLP patients treated with expansion appliances  T0- Before expansion
T1- After expansion 
 
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   Phase 4 
Date of First Enrollment (India)   28/05/2024 
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="2"
Months="0"
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 - NO
Brief Summary  

One of the most prevalent congenital abnormalities of the craniofacial region, cleft lip and palate(CLP) accounts for about 15% of all congenital deformities globally. The accompanying facial traits of children with CLP include a retrognathic maxilla and midface hypoplasia, which leads to diminished upper airway dimensions that do not improve even with surgical treatment. In children, the primary cause of respiratory problems is the obstruction of upper airway which is relieved by Rapid Maxillary Expansion (RME) which is also frequently employed to address the transverse deficiency. However, comparative studies show that Slow Maxillary Expansion(SME) provide more controlled anterior expansion than RME and is also equally effective in increasing pharyngeal airway volume in growing patients. Both Ni-Ti palatal expander and Aligners effectively causes SME, but aligners provide an added advantage to improve the alignment of dentition simultaneously with expansion. In this study, we will be doing a comparative assessment of volumetric airway changes in cleft lip and palate patients when treated with aligners and Ni-Ti palatal expander.


 
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