| CTRI Number |
CTRI/2025/05/087091 [Registered on: 19/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study is an in vivo study for a completely edentulous arch to evaluate the accuracy of digital scan impressions using two different scanning strategies and reference markers |
|
Scientific Title of Study
|
To Evaluate The Accuracy Of Digital Scan Impressions For Completely Edentulous Arch Using Two Different Scanning Strategies And Reference Markers - An In Vivo Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Arora |
| Designation |
Post Graduate Student |
| Affiliation |
DR HARVANSH SINGH JUDGE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL |
| Address |
Department of Prosthodontics
first floor, room number- 126
Chandigarh
CHANDIGARH
160001
India |
| Phone |
7988681428 |
| Fax |
|
| Email |
riya.ar.14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit Kumar |
| Designation |
Associate Professor |
| Affiliation |
DR HARVANSH SINGH JUDGE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL |
| Address |
DR HARVANSH SINGH JUDGE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL
Departement Of Prosthodontics and Crown and Bridge
first floor room number 126
Chandigarh
CHANDIGARH
160001
India |
| Phone |
9914419876 |
| Fax |
|
| Email |
drlalitbida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Arora |
| Designation |
Post Graduate Student |
| Affiliation |
DR HARVANSH SINGH JUDGE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL |
| Address |
Department of Prosthodontics and crown and bridge
first floor, room number - 126
Chandigarh
CHANDIGARH
160001
India |
| Phone |
7988681428 |
| Fax |
|
| Email |
riya.ar.14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital, Panjab university, sector- 25 chandigarh |
|
|
Primary Sponsor
|
| Name |
Panjab university |
| Address |
panjab university sector 25 chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Riya Arora |
DR HARVANSH SINGH JUDGE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL SECTOR 25 CHANDIGARH |
Department of Prosthodontics first floor room number 126
Chandigarh
CHANDIGARH |
7988681428
riya.ar.14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee panjab university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy volunteers with edentulous arch |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Digitized conventional cast |
For each arch, a conventional impression will be taken using suitable impression material, from which a definitive cast will be poured and digitized using an extraoral laboratory scanner. This digitized cast will serve as the reference scan (Rlab) for each arch. |
| Intervention |
Intraorally scanned ridges |
1st scan- Continuous/ Non-stitched complete arch scan without reference marks
2nd scan- Stitched complete arch scan without reference marks
3rd scan- Continuous/ Non-stitched complete arch scan with reference marks
4th scan- Stitched complete arch scan with reference marks
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a Healthy subjects having completely edentulous well rounded ridge in upper or lower jaw
b No infectious disease
c Age Subjects between 30 to 70 years of age
d Subjects having normal salivary flow and not taking any medication that would alter the quality or quantity of saliva
|
|
| ExclusionCriteria |
| Details |
a) Pregnant and lactating women
b) Subjects with temporomandibular joint disorder
c) Subjects having any tissue pathology, neuromuscular problem or need for pre prosthetic surgery
d) Extremely resorbed ridges
e) Flabby and hypertrophic/ hyperplastic mucosa
f) Subjects having high arched-palate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To investigate the scan accuracy of stitched digital scan and non-stitched digital scan to a reference scan for completely edentulous arch |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the influence of reference markers on the accuracy of the stitched & nonstitched digital scans for completely edentulous arch |
baseline |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
comparing the accuracy of the stitching and non-stitching technique in case of completely edentulous arch. In addition to that use of surgical markers for making reference marks intraorally to check whether using artificial reference markers has an effect on the accuracy of digital scan impressions and whether it facilitates superimposition of the digital scan images. This study will lead to a better understanding of the scanning strategy for obtaining a completely edentulous arch impression and the influence of using artificial landmarks for the same |