| CTRI Number |
CTRI/2024/09/073409 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the accuracy of digital
impression taken with intraoral scanner with the accuracy of impression taken
with impression materials ( traditional method) in patients with acquired upper
jaw ( maxilla) defects due to cancer, fungus, trauma. |
|
Scientific Title of Study
|
A parallel randomised control trial for comparison
of accuracy of digital impression versus conventional impression technique in
maxillectomy patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rekha Gupta |
| Designation |
Professor and Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9654700952 |
| Fax |
|
| Email |
dr_rekhagupta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rekha Gupta |
| Designation |
Professor and Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9654700952 |
| Fax |
|
| Email |
dr_rekhagupta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Patil |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9423837684 |
| Fax |
|
| Email |
Patilaish.patil83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Institute of Dental Sciences |
| Address |
Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi: 110002 |
| Type of Sponsor |
Government 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 Rekha Gupta |
Maulana Azad Institute of Dental Sciences |
Room 205, Department of Prosthodontics, second floor,Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi: 110002
Central
DELHI |
9654700952
dr_rekhagupta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional impression |
Accuracy of conventional impression acquired with
traditional impression materials in maxillectomy patients evaluated at time of intervention once |
| Intervention |
Intraoral scanner |
Accuracy of digital impression acquired with the help
of intraoral scanner in maxillectomy patients evaluated at time of intervention once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with unilateral maxillectomy defects who
will be reporting to the hospital and willing to participate in the study and havingAdequate number of teeth present on the non-defect side. |
|
| ExclusionCriteria |
| Details |
Bilateral maxillectomy defects or Active or recurrent lesions or Insufficient number of teeth present on the non-defect side. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measuring and comparing the accuracy of impressions taken using intraoral scanner and conventional impression materials |
Measuring and comparing the accuracy of impressions taken using intraoral scanner and conventional impression at time of delivery of Obturator once which will be set as baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recording and comparing the level of comfort and easiness of patient with impressions taken with intraoral scanner and conventional impression materials |
On the day of delivery of Obturator |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
05/09/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study will compare the accuracy and precision of cast of maxillectomy patients obtained from impression with digital method i.e. intraoral scanner with the cast obtained by conventional impression methods The accuracy of the cast will be evaluated by an expert prosthodontist on a likert scale. Further, the fit , retention and stability of the obturator that is fabricated in both group of patients will be evaluated by an expert prosthodontist as well as the patient on an obturator functioning scale. The comfort and patient satisfaction of the respective impression techniques will also be evaluated. |