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CTRI Number  CTRI/2017/02/007964 [Registered on: 27/02/2017] Trial Registered Prospectively
Last Modified On: 23/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Influence of orthopedic therapy in cleft lip palate patient 
Scientific Title of Study   3-DIMENSIONAL (3D) ASSESSMENT OF EFFECT OF ORTHOPEDIC TREATMENT MODALITIES IN NONSYNDROMIC UNILATERAL CLEFT LIP AND PALATE (NSUCLP) PATIENTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shahistha Parveen 
Designation  Reader 
Affiliation  Yenepoya University 
Address  R.no. 8 Department of Orthodontics Yenepoya University University Road Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  09886794150  
Fax    
Email  drshahistaparveen@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Shahistha Parveen 
Designation  Reader 
Affiliation  Yenepoya University 
Address  R.no.8 Department of Orthodontics Yenepoya University University Road Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  09886794150  
Fax    
Email  drshahistaparveen@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Shourya Hegde 
Designation  Reader 
Affiliation  Yenepoya University 
Address  Department of Orthodontics Yenepoya University Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9880488299  
Fax    
Email  mail@shourya.org  
 
Source of Monetary or Material Support  
Yenepoya University University Road, Deralakatte, Mangalore 575018. 
 
Primary Sponsor  
Name  Yenepoya University 
Address  Yenepoya University University Road, Deralakatte, Mangalore 575018 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Yenepoya University  University Road, Deralakatte, Mangalore 575018. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Srinivas Gosla Reddy  GSR Institute of Craniofacial Surgery  17-1-383/55 Vinay Nagar Colony I S Sadan Saidabad Hyderabad
Hyderabad
ANDHRA PRADESH 
9849016969

goslareddy@gmail.com 
Dr Akhter Husain  Yenepoya University  Department of Orthodontics Yenepoya University Mangalore
Dakshina Kannada
KARNATAKA 
9845084266

drakhter@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
GSR institute of facial and plastic Surgery  Approved 
YenepoyaUniversitEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cleft patients undergoing skeletal correction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Facemask with expansion appliance   CBCT will be taken before the initiation of treatment (T0) and after the completion of orthopedic treatment (T1) to assess and compare the changes associated with different devices. 
Intervention  Max gym with expansion appliance  CBCT will be taken before the initiation of treatment (T0) and after the completion of orthopedic treatment (T1) to assessthe changes associated with the device. 
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. Patients with NSUCLP between the age of 9-16 years.
2. Cleft patients in mixed/ permanent dentition.
3. Cleft patients with a history of primary surgery for repair of cleft lip and palate need to address sagittal discrepancy.
4. Cleft patients with constricted arch need to undergo expansion.
5. No gross facial symmetry determined clinically.
  
 
ExclusionCriteria 
Details  1. Syndromic cleft lip and palate patients.
2. Bilateral cleft lip and palate patients
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To check whether intervention appliance can be used as substitute for orthopedic correction  12months after the appliance intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Newly introduced appliance can
generalized in all population with deficient maxilla  
Not applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2017 
Date of Study Completion (India) 22/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Non yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Cleft lip and palate is one of the commonest craniofacial disorders with incidence ranging from 1 in 300 to 1 in 2,500 live births. In India, 78 cleft infants are born every day, or 3 infants with clefts born every hour. Cleft lip and palate patients need extensive treatment from early age until adulthood. Primary surgeries have an effect on growth of the maxillofacial complex.

Deficient maxilla (both in transverse and sagittal dimension) is one of the most common features of surgically corrected cleft lip and palate which is thought to be due to the presence of the scar tissue.

 To correct the transverse discrepancies, orthodontists often use orthopedic appliances such as expansion appliances and to correct the sagittal discrepancies, face mask is used. The combined use of expansion appliance and a facemask is a contemporary technique for maxillary protraction during growth in cleft patients. However, the use of facemask has few shortcomings such as long duration of wear and the efficacy of appliance is highly dependent on patient compliance. Max gym is a dentofacial orthopaedic apparatus, proposed to protract the maxilla using variable weights stacked upon a pulley mechanism via a maxillary splint with incorporated expansion appliances. The patient is trained to pull away from this appliance which will help in correcting maxillary deficiency in sagittal and transverse dimension. The difference between face mask and the max gym is that, the anchorage taken by the appliance is from the wall as opposed to the patient’s chin and forehead as in face mask therapy. The forces used to bring about skeletal changes in max gym are heavier and the duration of use is much lesser unlike the face mask which has lighter and continuous forces. Patient’s compliance is better as it eliminates wearing of extra oral appliance for longer duration. There is general agreement that orthopedic forces applied to the maxillary complex are more effective in growth modulation and invasive surgical procedure can be minimized/avoided at a later date. 

This study will assess and compare the changes in craniofacial structures by two different protraction appliances using Cone Beam Computed Tomography (CBCT).

 
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