| CTRI Number |
CTRI/2021/02/031576 [Registered on: 26/02/2021] Trial Registered Prospectively |
| Last Modified On: |
23/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of digital and tray impression technique for recording details of cleft lip and palate in new born child |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF DIGITAL AND TRAY IMPRESSION TECHNIQUE AS A METHOD OF RECORDING ANATOMICAL DETAILS OF CLEFT LIP AND PALATE IN NEONATES
–A RANDOMIZED CONTROLLED CLINICAL TRIAL
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
karthika kk |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept. of pediatric dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8943266224 |
| Fax |
|
| Email |
karthikakrishnakumar27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
karthika kk |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept. of pediatric dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8943266224 |
| Fax |
|
| Email |
karthikakrishnakumar27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritesh Kalaskar |
| Designation |
Professor |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept. of pediatric dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8550938585 |
| Fax |
|
| Email |
riteshpedo@gmail.com |
|
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Source of Monetary or Material Support
|
| Government Dental College and Hospital Nagpur |
|
|
Primary Sponsor
|
| Name |
Karthika KK |
| Address |
Dept. of pediatric dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur |
| Type of Sponsor |
Other [Self funded] |
|
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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 |
| Dr Karthika kk |
Government Dental College and Hospital Nagpur |
Department of Pediatric and Preventive Dentistry Room 108 First floor Government Medical Campus, Hanuman Nagar Nagpur-440003
Nagpur
MAHARASHTRA |
8943266224
karthikakrishnakumar27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital 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: Q375||Cleft hard and soft palate with unilateral cleft lip, (2) ICD-10 Condition: Q375||Cleft hard and soft palate with unilateral cleft lip, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digital impression technique |
Recording anatomical details of cleft lip and palate using digital impression technique in neonates
To evaluate accuracy of digital impression technique and adaptation of feeding plate fabricated using the same.
|
| Comparator Agent |
Tray impression technique |
Recording anatomical details of cleft lip and palate using tray impression technique in neonates
To evaluate accuracy of tray impression technique and adaptation of feeding plate fabricated using the same. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
15.00 Day(s) |
| Gender |
Both |
| Details |
Non syndromic male and female cleft lip and palate neonates of 1-15 days of age.
Veau’s Class III, cleft lip and palate cases
Moderate to well- nourished healthy infants (birth weight ≥ 2500gm)
|
|
| ExclusionCriteria |
| Details |
Cleft associated with other anomalies and syndromes
Systemically compromised infants
Parents/ guardian not willing to participate in the study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Accuracy of digital and tray impression as a method of recording cleft lip and palate (Veaus Class III) in neonates
Adaptation of feeding plate fabricated using digital and tray impression technique |
18months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the perception of parents regarding digital and tray impression technique and operator anxiety during recording of impression using both the techniques. |
18months |
|
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Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2021 |
| Date of Study Completion (India) |
21/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/02/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
yet to published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
This study is an open, parallel group, randomized controlled clinical trial evaluating digital and tray impression technique as a method for recording anatomical details of cleft lip and palate in neonates. The study will be conducted on 16 neonates of 1-15 days old with cleft lip and palate {Veau’s class III) reporting to the department of Pediatric and Preventive Dentistry. The primary outcome is to evaluate accuracy of anatomical details of cleft lip and palate recorded using digital and tray impression technique and adaptation of feeding plate fabricated using the same in cleft lip and palate neonates. Secondary outcome is to assess the perception of parents regarding digital and tray impression technique and operator anxiety during recording of impression using both the techniques. |