| 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
|
|
|
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
|
|
|
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 . |