| CTRI Number |
CTRI/2020/10/028407 [Registered on: 14/10/2020] Trial Registered Prospectively |
| Last Modified On: |
11/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to compare digital and regular impressions accuracy in case of individuals completely lacking teeth |
|
Scientific Title of Study
|
A comparative evaluation between accuracy of intraoral digital and conventional
completely edentulous arch impressions: An in vivo study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aarushi Anand |
| Designation |
Post graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Room no 2,Department of Prosthodontics,Rajarajeswari Dental College and Hospital,No 14,Ramohalli cross,Kumbalgodu,Mysore Road,Bengaluru,Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
7004796836 |
| Fax |
|
| Email |
anandaarushi@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Shetty |
| Designation |
Head of the Department |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Room no 2,Department of Prosthodontics,Rajarajeswari Dental College and Hospital,No 14,Ramohalli cross,Kumbalgodu,Mysore Road,Bengaluru,Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
9886012845 |
| Fax |
|
| Email |
gautamshettydental@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarushi Anand |
| Designation |
Post graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Room no 2,Department of Prosthodontics,Rajarajeswari Dental College and Hospital,No 14,Ramohalli cross,Kumbalgodu,Mysore Road,Bengaluru,Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
7004796836 |
| Fax |
|
| Email |
anandaarushi@ymail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College and Hospital,No 14,Ramohalli cross,Kumbalgodu,Mysore road,Bengaluru,Karnataka 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Aarushi Anand |
| Address |
Room no 2,Department of Prosthodontics,Rajarajeswari Dental College and Hospital,No 14,Ramohalli cross,Kumbalgodu,Mysore road,Bengaluru,Karnataka 560074 |
| 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 |
| Dr Aarushi Anand |
Rajarajeswari Dental College and Hospital |
Room no 2,Department of Prosthodontics,Rajarajeswari Dental College and Hospital,No 14,Ramohalli cross,Kumbalgodu,Mysore road,Bangalore,Karnataka 560074
Bangalore
KARNATAKA |
7004796836
anandaarushi@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Rajarajeswari Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional impression |
Conventional impression using impression compound on completely edentulous maxillary arches |
| Intervention |
Digital impressions |
Digital impressions on completely edentulous maxillary arches using Intraoral scanner (TRIOS3, 3Shape AS Denmark) |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Completely edentulous patients with healthy soft tissues |
|
| ExclusionCriteria |
| Details |
1)Subjects with congenital anomalies/malformations
2) Previous orthognathic surgery
3) Allergic to impression material
4) Bony and soft tissue protuberances, active lesions, deformity or scars and trauma of the palate.
5)Patients with inadequate mouth opening
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the accuracy of conventional and digital methods for generating full arch impressions in completely edentulous patients |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comfort and acceptability of digital impressions by patients |
2 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of our study is to evaluate the feasibility of using contemporary intraoral scanners (IOSs)
to digitize edentulous jaws and to verify the accuracies of the obtained data.The objective is to compare the accuracy of conventional and
digital methods for generating full arch impressions in completely edentulous
patients in an in vivo situation.A total of 20 completely edentulous cases, who shall visit the hospital
for their complete denture treatment will be taken for the study and subjected to conventional and digital impression techniques for taking impressions of the maxillary arch.The conventional impressions will be scanned with the reference scanner using a
highly accurate protocol for scanning large objects. The scanned data will be
exported in the stereo lithography (STL) data format.To
compare the impressions within each test group, the scan data will be
superimposed using special diagnostic software, which will use a best-ï¬t
algorithm to match 2 surfaces, and the differences will be analysed. |