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CTRI Number  CTRI/2024/05/066991 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of dental impression techniques in children  
Scientific Title of Study   To compare digital and conventional impression techniques in terms of comfort time and accuracy  
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpa SNaik 
Designation  Professor and Head of department  
Affiliation  D Y Patil school of dentistry Navi Mumbai  
Address  Department of pediatric and preventive dentistry,basement D Y Patil school of dentistry sector 7 , High way road nerul navi mumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  9769600440  
Fax    
Email  shilpa.naik@dypatil.edu  
 
Details of Contact Person
Scientific Query
 
Name  MAYURI GORULE 
Designation  Post graduate student  
Affiliation  D Y Patil school of dentistry Navi Mumbai  
Address  Department of pediatric and preventive dentistry,basement D Y Patil school of dentistry sector 7 , High way road nerul navi mumbai

Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  09035494120  
Fax    
Email  mayurigorule97@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MAYURI GORULE 
Designation  Post graduate student  
Affiliation  D Y Patil school of dentistry Navi Mumbai  
Address  Department of pediatric and preventive dentistry,basement D Y Patil school of dentistry sector 7 , High way road nerul navi mumbai

Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  09035494120  
Fax    
Email  mayurigorule97@gmail.com  
 
Source of Monetary or Material Support  
Department of pediatric and preventive dentistry D.Y.Patil deemed to be university School of dentistry navi mumbai  
 
Primary Sponsor  
Name  DrD YPatil school of dentistry Navi mumbai  
Address  Dr.D.Y.Patil Deemed to be University ,School of Dentistry ,Sector 7 ,Highway Road,Nerul,Navi Mumbai Maharastra 400706 
Type of Sponsor  Private medical college 
 
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 
Dr ShilpaSNaik   Dr.D.Y.Patil dental college and hospital navi mumbai   Post graduate clinic department of pediatric and preventive dentistry basement D.Y.Patil deemed to be univeristy School of Dentistry Sector 7 Highway road Nerul Navi Mumbai THane maharashtra 400706
Mumbai (Suburban)
MAHARASHTRA 
9769600440

shilpa.naik@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research and ethical board ,D.Y.Patil Deemed to be university School Of Dentistry ,Navi Mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Alginate impression material   Dentsply slow setting alginate impression material  
Intervention  Digital intraoral scanner   Digital intraoral scanner that is iscan pro scanner  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children with class 1 ASA status
Frankl behaviour rating 3 and 4
Requiring impressions for appliances and study models
No history of previous impressions taken  
 
ExclusionCriteria 
Details  Children with presence of swelling
Children whose parents did not give consent and did not participate in study  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare digital and conventional impression techniques in terms of comfort ,time and accuracy   once 
 
Secondary Outcome  
Outcome  TimePoints 
Digital impression can be an alternative to conventional impression method   3 months  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/05/2024 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Over the years, diagnosis and treatment procedures have relied on plaster models , though the plaster models used in diagnosis and treatment procedures , they have their own disadvantages .Such as , plaster models involves multiple steps, including taking impressions, pouring plaster, and waiting for it to set. This process can be time-consuming and may delay treatment planning.Plaster models are physical objects that require storage space and can be bulky to transport. They can also be fragile and may break during handling or shipping.Plaster models may not always capture fine details accurately, especially in complex cases or with delicate structures like margins or interproximal areas. Plaster models can distort over time due to changes in humidity or temperature, potentially affecting their accuracy and usefulness for treatment planning.Taking impressions for plaster models can be uncomfortable for patients, especially those with a strong gag reflex or sensitivity to materials.Plaster models require materials like gypsum, which can have environmental implications due to mining and manufacturing processes. Additionally, the disposal of used models can contribute to waste.Overall , while plaster models have been a staple in dentistry for many years, advancements in digital technology offer several advantages over traditional methods, including improved accuracy, efficiency, and patient comfort .

 Given this, digital intraoral scanners have emerged as a dominant trend in dentistry, transforming the viability of intraoral scans and digital models as an alternative to traditional impressions. An intraoral scanner is a handheld device used to directly create digital impression data of the oral cavity. Light source from the scanner is projected onto the dental arches, and then a 3D model processed by the scanning software will be displayed in real-time on a touch screen. The device provides accurate details of the hard and soft tissues located in the oral area through high-quality images. This technology offers several advantages, including patient comfort, particularly beneficial for anxious children or those sensitive to gagging or nausea. Additionally, it facilitates improved communication between colleagues and laboratories, reduces waste, lowers shipping costs to laboratories, eliminates the risk of disease transmission, and eliminates the need for articulation of casts for occlusal corrections.

As intraoral scanning technology continues to advance with smaller scanners and faster acquisition times, patients and paediatric dentists may show an increased preference for digital impressions.

Despite the promising aspects, research on the use of digital impression is limited to paediatric dentistry and studies evaluating the concordance of the images obtained from intraoral scanning and the impact of this technique on children. Hence, this study aimed to compare digital and conventional impression methods regarding comfort, accuracy, and time in children aged 7 to 9 years of age .   
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