| CTRI Number |
CTRI/2024/09/074134 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Accuracy of artificial teeth set making procedure in patients with no teeth using different video scanners |
|
Scientific Title of Study
|
Accuracy Of Maxillary Edentulous Digital Models Generated From Final Impressions And Gypsum Models Using Intra-Oral Scanner And Model Scanner |
| 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 Pakalapati Devi Suma |
| Designation |
MDS Student |
| Affiliation |
Vishnu Dental College |
| Address |
PG Clinic-8,Block-2,Department of Prosthodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9490157777 |
| Fax |
|
| Email |
suma.pakalapati@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Guduri Vineeth |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
PG Clinic-8,Block-2, Department of Prosthodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951581618 |
| Fax |
|
| Email |
guduri.vineeth@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Guduri Vineeth |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
PG Clinic-8,Block-2, Department of Prosthodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951581618 |
| Fax |
|
| Email |
guduri.vineeth@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavarm-534202, West Godavari District, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Pakalapati Devi Suma |
| Address |
Vishnu Dental College, Department Of Prosthodontics, PG Clinic-8, Vishnupur, Bhimavarm-534202, West Godavari District, Andhra Pradesh, India |
| 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 Pakalapati Devi Suma |
Vishnu Dental College |
PG Clinic-8,Block-2, Department Of Prosthodontics, Vishnu Dental College, Vishnupur, Bhimavaram-534202
West Godavari
ANDHRA PRADESH |
9490157777
suma.pakalapati@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
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 |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having completely edentulous maxillary arch. |
|
| ExclusionCriteria |
| Details |
Patients with Completely edentulous Maxillary arch having unhealed sockets and bony spicules. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Digital measurement of distance between four markers which will be placed on the completely edentulous maxillary final impression and will be scanned using intra-oral scanner and model scanner. |
1hour after making the final impression. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Completely edentulous maxillary final impression with four markers will be poured with type III dental stone to make gypsum model. It will be scanned using intra-oral scanner and model scanner to generate digital model STL files. The distance between markers will be generated to verify the accuracy. |
Gypsum models will be poured 2hours after making the final impression. |
| Digital measurement of distance between four markers reproduced on the completely edentulous maxillary master models which will be poured from the final impressions, after scanning using intra-oral scanner and model scanner. |
2hours after making the final impression. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The aim of the study is to evaluate the accuracy of digital models generated from scanned maxillary edentulous final impressions and gypsum models using intra-oral scanner and model scanner. Methodology- Completely edentulous maxillary final impression will be made using special tray from the patient. Four markers will be placed on the the final impression which will be scanned by Intra-oral scanner and model scanner to generate digital model STL files. Afterwards, the final impression will be poured using type III dental stone to make gypsum model. Then, the obtained gypsum model will be scanned by the same Intra-oral scanner and model scanner to get digital model STL files. The distance between the four markers will me measured on each obtained STL file for verifying accuracy. The digital model STL file acquired from scanning gypsum model by model scanner will be used as reference scan, to which the other all digital model STL file will be compared to evaluate the accuracy. |