| CTRI Number |
CTRI/2019/02/017486 [Registered on: 06/02/2019] Trial Registered Prospectively |
| Last Modified On: |
27/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To study change in size of the hole present in palate ( roof) of the mouth and gap present in jaw and lip using two different technique technique in orofacial cleft patient. |
|
Scientific Title of Study
|
Comparative evaluation of nasal and alveolar changes in complete unilateral cleft lip and palate patient using Intraoral and Extraoral nasoalveolar molding technique. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Bhaje |
| Designation |
post graduate student |
| Affiliation |
Govt. Dental College & Hospital Nagpur |
| Address |
Department of Pedodontics and Preventive Dentistry, Govt. Dental College and Hospital Nagpur, Govt.Medical Campus Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8830392231 |
| Fax |
|
| Email |
priyanka22bhaje@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Bhaje |
| Designation |
post graduate student |
| Affiliation |
Govt. Dental College & Hospital Nagpur |
| Address |
Department of Pedodontics and Preventive Dentistry, Govt. Dental College and Hospital Nagpur, Govt.Medical Campus Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8830392231 |
| Fax |
|
| Email |
priyanka22bhaje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritesh Kalaskar |
| Designation |
Professor and Guide |
| Affiliation |
Govt. Dental College & Hospital Nagpur |
| Address |
Department of Pedodontics and Preventive Dentistry, Govt. Dental College and Hospital Nagpur, Govt.Medical Campus Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8550938585 |
| Fax |
|
| Email |
riteshpedo@gmail.com |
|
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Source of Monetary or Material Support
|
| Govt.Dental college and Hospital Nagpur. Govt. medical campus Nagpur. |
|
|
Primary Sponsor
|
| Name |
Priyanka Bhaje |
| Address |
Dept. of Pedodontics and Preventive Dentistry Room no.109 Govt. Dental college & Hospital , Nagpur.Govt. Medical Campus Nagpur.Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyanka Bhaje |
Govt. Dental college and Hospital Nagpur |
Department of Pedodontics and Preventive Dentistry Room no.109.
Nagpur
MAHARASHTRA |
8830392231
priyanke22bhaje@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt. Dental College Nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
extraoral nasoalveolar molding technique |
nasal stent made up of soft stainless steel wire and self cure acrylic resin and lined by soft tissue liner. 3M steri strip adhesive tape for lip tapping. |
| Comparator Agent |
Intraoral nasoalveolar molding technique |
Intraoral acrylic plate madeup of self cure acrylic resin and nasal stent made up of soft stainless steel wire and cold cure acrylic resin. Intraoral plate and nasal stent is lined with soft tissue liner. |
|
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Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
1)Infants below 7 days of age.
2)All non-syndromic Infants.
3)Infants not associated with any systemic illness.
4)Moderately to well nourished healthy Infants.
|
|
| ExclusionCriteria |
| Details |
1)Infants above 7 days of age.
2)Syndromic, malnourished and systemically ill Infants.
3)Guardians who will be unwilling to go through the NAM therapy.
4)Isolated cleft palate, cleft lip and bilateral cleft lip and palate cases.
5)All unoperated unilateral cleft lip and palate cases.
|
|
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Intra alveolar cleft width, total alar base width,collumellar length |
Baseline- 7 days
Post treatment - 3 month |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Nostril height, nostril width (cleft side and non cleft side) |
Base line - 7 days
Post treatment - 3 month |
|
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Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2019 |
| Date of Study Completion (India) |
04/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Cleft lip and palate is the most common congenital anomaly of craniofacial region.Infants born with unilateral cleft lip and palate have characteristic signs like nasal asymmetry due to a shortened columella, displaced alar base, asymmetric and displaced nostril tip and missing nasal floor.Surgeons all over the world tried to improve the aesthetic outcome of this disorder after surgery but the results are unsatisfactory. Nasoalveolar molding (NAM)plays a significant role to improves the aesthetic and functional aspects of nose and maxilla before surgery. It consists of an intraoral molding plate with nasal stent (Intraoral NAM technique) to mold the alveolar ridge and nasal cartilage concurrently.The objective of the NAM is to reduce the severity of the original cleft deformity and thereby significantly improve the surgical outcome of primary lip repair.However for the patient living in remote area where the facilities are not readily available it is difficult for parents to visit the hospital frequently for weekly activation of NAM plate. This makes NAM a poor choice for cleft lip and palate patient due to poor compliance..Cases have been reported in the literature showing NAM technique done by using adhesive lip tapping and nasal stent (Extraoral NAM technique). Adhesive lip tapping with nasal stent alone can decrease the gaps between alveolar segment and tension of the lip and also nasal stent is activated once in a month. Therefore the overall cost is reduced and compliance of both patient and parent is improved.But till date no comparative studies have been reported in the literature showing the efficiency of Extraoral nasoalveolar molding technique. With this background the present study is planned to evaluate nasal and alveolar changes in complete unilateral cleft lip and palate infants ( both right and left side ) using Intraoral and Extraoral NAM technique.
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