| CTRI Number |
CTRI/2024/01/061513 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of the retention of denture record bases taken by from conventional impression and digital scan. |
|
Scientific Title of Study
|
Comparative evaluation of retention of record bases fabricated using conventional impression and modified digital scan for complete denture. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima Agrawal |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Prosthodontics and crown & Bridge. Sharad Pawar Dental College and Hospital, Sawangi, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9834263690 |
| Fax |
|
| Email |
mahimaagrawal41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anjali Borle |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Prosthodontics and crown & bridge. Sharad Pawar Dental College and Hospital, Sawangi, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7879960525 |
| Fax |
|
| Email |
dranjaliborle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahima Agrawal |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Prosthodontics and crown & Bridge. Sharad Pawar Dental College and Hospital, Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9834263690 |
| Fax |
|
| Email |
mahimaagrawal41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research |
| Sharad Pawar Dental College and Hospital, Sawangi, Wardha |
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College and Hospital |
| Address |
Sharad Pawar Dental College and Hospital, Sawangi, Wardha |
| 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 Mahima Agrawal |
Sharad Pawar Dental College and Hospital |
Department of Prosthodontics and Crown & Bridge, Floor no 2, room no 202, Sharad Pawar Dental College and Hospital, Sawangi, Wardha
Wardha
MAHARASHTRA |
9834263690
mahimaagrawal41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research, Deemed to be University, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients being willing to participate in the study.
Patients having signed informed consent form.
Patients with well-formed edentulous maxillary arch
|
|
| ExclusionCriteria |
| Details |
Patients with excessive maxillary ridge resorption. Having bony undercut of more than 2mm in the maxillary ridge will be excluded. Patients with poor neuromuscular control. Patients with malignancies. Patients with flabby ridge, papillary hyperplasia.
• Patients with epulis fissuratum.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study integrates the modified digital scans in the workflow of complete denture fabrication. Modified Digital impression will result in more time efficient technique than conventional impression. By the end of the study, we will know whether resiliency of tissues can be recorded by modified digital scans. |
This study will be carried out for a period of 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study integrates the modified digital scans in the workflow of complete denture fabrication. Modified Digital impression will result in more time efficient technique than conventional impression. By the end of the study, we will know whether resiliency of tissues can be recorded by modified digital scans. |
At time of jaw relation. This study will be caried out over a period of 1 year. |
|
|
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)
|
25/04/2024 |
| 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="2"
Months="3"
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
|
An study will be conducted on patients who
present to the OPD with completely edentulous maxillary and mandibular jaw. A
thorough intraoral examination will be carried out. In
group â…
patients conventionally border molded impression with a custom tray will be
made and a definitive cast will be obtained. A record base with heat polymerizing
acrylic resin will be made on the definitive cast. In
group â…¡
patients the maxilla will be scanned using an intraoral scanner. The scanned
image will be modified by incorporating coding calculations according to the
resiliency of the tissues. Using the modified scanned image, the CAD-CAM bases will
be milled. A
platform will be designed with a 45-degree inclination. A dislodging force will
be applied via a dynamometer connected to a hook. This will simulate the
dislodging force thus, clinically testing record base retention. The
retention offered by the conventional record base and CAD-CAM milled record
bases from the modified intraoral scan will be compared. |