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CTRI Number  CTRI/2020/01/022796 [Registered on: 15/01/2020] Trial Registered Prospectively
Last Modified On: 07/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Feeding plates for New born babies having a hole in the roof of the mouth. 
Scientific Title of Study   Effectiveness of modified Naso alveolar moulding appliance on feeding and Naso alveolar moulding in unilateral cleft lip and palate babies 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeetha M G  
Designation  Assistant Professor  
Affiliation  SRM Dental College,SRMIST 
Address  second floor,Department of Orthodontics, SRM Dental college 89,bharathi salai
ramapuram
Chennai
TAMIL NADU
600088
India 
Phone  9941314956  
Fax    
Email  sangsortho@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nirmala Anandan 
Designation  HOD and Professor 
Affiliation  SRM Dental College,SRMIST 
Address  Second floor,Department of Biochemistry,BMS block, SRM Dental college 89,bharathi salai Ramapuram
ramapuram
Chennai
TAMIL NADU
600088
India 
Phone  9600164708  
Fax    
Email  dr_s_nirmala@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Sangeetha M G  
Designation  Assistant Professor  
Affiliation  SRM Dental College,SRMIST 
Address  Second floor,Department of Orthodontics, SRM Dental College, 89,bharathi salai
ramapuram
Chennai
TAMIL NADU
600088
India 
Phone  9941314956  
Fax    
Email  sangsortho@gmail.com  
 
Source of Monetary or Material Support  
Sangeetha.M G Assistant Professor SRM Dental college,SRMIST Ramapuram,Chennai  
 
Primary Sponsor  
Name  Prinicipal InvestigatorDr Sangeetha M G  
Address  Assistant Professor,Department Of Orthodontics,SRM Dental College, 89,ramapuram salai;chennai 
Type of Sponsor  Other [Self] 
 
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 
sangeetha  SRM Dental College  Deprtment of Orthodontics,II floor,89,bharathi salai ramapuram chennai
Chennai
TAMIL NADU 
9884597783

mgsortho@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: Q371||Cleft hard palate with unilateralcleft lip,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Acrylic Plate  Self Cure Acrylic.The duration device usage is 3 months. 
Intervention  Polyamide Naso Alveolar Moulding Appliance  Poyamide Material will be used instead of Acrylic.The total duration of the device usage will be 3 months  
 
Inclusion Criteria  
Age From  2.00 Day(s)
Age To  90.00 Day(s)
Gender  Both 
Details  non syndromic newborn unilateral cleft lip and palate babies  
 
ExclusionCriteria 
Details  1.syndromic cleft lip and palate patients
2.presentation with other medical condition 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effective naso alveolar moulding and breast feeding  At the start and At the End of 3 months/12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
pycological improvement of mothers due to better breast feeding .  At the start and At the end of 12 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/01/2020 
Date of Study Completion (India) 07/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Cleft Lip and Palate is one of the most common craniofacial deformities occurring all over the world and has a higher ratio in India. Apart from serious problems like aspiration, infections, poor growth and development of the affected child, the family undergoes emotional struggles, postpartum depression of the new mothers, long term burden of care etc., Feeding the babies is one of the most important and immediate post-natal concern. Feeding plates, special bottles and nipples are available to facilitate feeding of cleft babies. Patients undergo many surgeries for correction of the cleft deformity from the age of 3 months. Reconstruction of the lips, palate and nose to normal anatomy is a challenge for surgeons. Presurgical Infant Orthopedics(PSO) was developed as an adjunct to the surgical management. Presurgical nasoalveolar moulding appliance (PNAM), a type of PSO was introduced by Grayson and Cutting, based on Matsuo’s cartilaginous moulding concept. This technique takes advantage of the malleability of immature cartilage and its ability to maintain a permanent correction of its form. The Primary goal of PNAM is to decrease the severity of the primary cleft deformity and provide symmetry to distorted nasal cartilage along with Nonsurgical lengthening of the columella. Approximation of lip segments and reduction of the cleft size decreases tension in the tissues during and after surgery reducing the severity of scarring. This produces a better surgical outcome of the lip repair and reduces the number of surgical revisions for nasal correction. Unlike other PSOs, NAM not only moulds the alveolar cartilage, but also the nasal cartilage, into near normal form and symmetry through a nasal stent.

 These appliances generally facilitate feeding while reducing the cleft size. But, due to lack of complete oral seal, feeding especially breast feeding is still not completely effective with these babies. With the availability of newer materials like polyamide based denture materials, appliances can be made, to produce better intra oral suction facilitating easy feeding and more comfortability. This research on modified NAM appliance will not only improve alveolar and nasal moulding but also improve the baby’s overall growth and development with effective feeding while alleviating the apprehension of parents leading to a successful childhood.

 
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