FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056754 [Registered on: 22/08/2023] Trial Registered Prospectively
Last Modified On: 09/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparison between 2 different treatment methods to treat infants affected by a genetic defect called cleft lip and palate 
Scientific Title of Study   Qualitative and Quantitative Comparative Evaluation of treatment of Unilateral Cleft Defect of the Lip and Palate using a 3D Printed Passive Pressure Plate and the Nasoalveolar Moulding Device – A Randomised Control 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  Niharika Bhatia 
Designation  Post graduate student 
Affiliation  Department of Orthodontics, Saveetha Dental College and hospital 
Address  Saveetha dental college and hospital, Chennai

Chennai
TAMIL NADU
600077
India 
Phone    
Fax    
Email  152108007.sdc@saveetha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aravind Kumar Subramanian 
Designation  Head of Department , Dean 
Affiliation  Saveetha Dental coillege and hospital 
Address  Department 27, Department of Orthodontics and Dentofacial Orthopedics, Saveetha Dental College and Hospital, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9841299939  
Fax    
Email  aravindkumar@saveetha.com  
 
Details of Contact Person
Public Query  
Name  Dr Aravind Kumar Subramanian 
Designation  Head of Department , Dean 
Affiliation  Saveetha Dental coillege and hospital 
Address  Department no 27, Department of Orthodontics and dentofacial orthopedics, Saveetha Dental College and Hospital, Chennai


TAMIL NADU
600077
India 
Phone  9841299939  
Fax    
Email  aravindkumar@saveetha.com  
 
Source of Monetary or Material Support  
Department of Orthodontics, Saveetha Dental College and Hospital, Chennai. 
 
Primary Sponsor  
Name  Niharika Bhatia 
Address  Saveetha Dental College and Hospital, Poonamallee high road, Vellapanchavadi 
Type of Sponsor  Other [self sponsor] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Niharika bhatia  Saveetha Dental College and Hospital   Clinic 27, Department of Orthodontics Saveetha dental college and hospital,Chennai
Chennai
TAMIL NADU 		 9711121996

152108007.sdc@saveetha.com 
Niharika bhatia  Saveetha Dental College and Hospital   Department of Oral and Maxillofacial Surgery (clinic 20) Saveetha Dental college and hospital, Chennai
Chennai
TAMIL NADU 		 9711121996

152108007.sdc@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Dental College-Institutional human ethical committee SDCIHEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q371||Cleft hard palate with unilateralcleft lip, (2) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D printed Passive Presurgical infant orthopedic plate  To 3D print a plate using acrylic resin material after taking an intraoral scan for the infant. 
Comparator Agent  Active presurgivcal infant orthopedics in the form of -Nasoalveolar moulding device   The NAM plate is fabricated manually on a plaster cast, using cold cure acrylic resin material after taking a highly accurate impression on the maxilla of the infant using putty impression material. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  3.00 Month(s)
Gender  Both 
Details  1.Neonates with a complete unilateral cleft of the lip and palate
2.Under the age of 3 months.
3.Neonates with no neuromuscular disorder
 
 
ExclusionCriteria 
Details  1.Neonates with bi-lateral cleft defect.
2.Above the age of 3 months.
3. Severe systematic illness.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.To measure the total volume of the cleft defect using the 3D software as measured in the base article at 3 different times – start , after 1 months, before surgery)

2. To check the changes in cleft width , cleft area, height of the palatal surface.

2. To measure the periodic weight gain of the baby , in both groups .

 		 initial, 1.5 months, 3 months

 
 
Secondary Outcome  
Outcome  TimePoints 
3. Aesthetic results obtained following surgical approximation.

4 The ease of the surgeon to approximate the 2 segments

5. The ease for the mother/caregiver to re-place the device & during breast feeding 		 initial, 1.5 months , 3 months 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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)   31/08/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
    Response -  Analytic Code

  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 [152108007.sdc@saveetha.com].

  6. For how long will this data be available start date provided 02-11-2024 and end date provided 19-09-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

PARTICIPANTS ARE SCREENED AND CHECKED TO FIT INTO THE INCLUSION CRITERIA.  A SAMPLE SIZE OF 14 PATIENTS IS SELECTED WITH THE COMPLETE UNILATERAL CLEFT OF THE LIP AND PALATE and are randomly divided into 2 groups. Group 1: included those patients who will be treated by a passive presurgical infant orthopedic plate- or the 3-D printed passive pressure plate, while Group 2 included those patients to be treated with active presurgical infant orthopedics ie. conventional nasoalveolar molding device.

All the children falling under both these groups will be evaluated based on 3D intraoral scans that will be taken using a common intraoral scanner, at 3-time intervals - initial (pre-treatment scan ), after 1.5 months and at 3 months. 

The main outcomes that will be assessed will fall into two broad categories: Quantitative and Qualitative assessment.

The volumetric and area analysis of the cleft defect will be assessed using the 3D software and compared for both groups for a comparative evaluation, to sess the effectiveness of both the methods of presurgical infant orthopedics.


 
Close