| 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
|
|
|
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
|
|
|
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. | |