| CTRI Number |
CTRI/2019/08/020963 [Registered on: 29/08/2019] Trial Registered Prospectively |
| Last Modified On: |
26/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of functioning of two different types of prosthetic plates in patients with upper jaw resection |
|
Scientific Title of Study
|
To compare the functioning of delayed surgical obturator fabricated using conventional and vacuum formed method in maxillectomy patients: A randomized control 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 Tosin C |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
2nd floor
CDER
AIIMS
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9449354233 |
| Fax |
|
| Email |
tosinc5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Jain |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Prosthodontics
CDER
AIIMS
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868187441 |
| Fax |
|
| Email |
jainveena1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dheeraj Koli |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Prosthodontics
CDER
AIIMS
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958661988 |
| Fax |
|
| Email |
dr.dheerajkoli@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CDER |
| Address |
CDER
AIIMS
New Delhi
PIN:110029 |
| 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 Tosin C |
All India Institute of Medical Sciences, New Delhi |
2nd floor, Department of
Prosthodontics, Centre of Dental Education and Research
New Delhi
DELHI |
9449354233
tosinc5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduates AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C050||Malignant neoplasm of hard palate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed surgical obturator using autopolymerising acrylic resin(conventional method) |
obturator functioning, psychological distress and quality of life will be measured at 48 hours and 5 weeks after insertion of prosthesis using questionnaire survey |
| Intervention |
Delayed surgical obturator using vacuum formed thermoplastic sheet |
obturator functioning, psychological distress and quality of life will be measured at 48 hours and 5 weeks after insertion of prosthesis using questionnaire survey |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Maxillectomy patients indicated for prosthetic rehabilitation |
|
| ExclusionCriteria |
| Details |
Patients with associated midfacial defect
Patients with involvement of soft palate, mandible or tongue.
Patients with defect of soft palate only
Patients not willing to undergo prosthodontic treatment
Patients with completely edentulous arches
Total bilateral maxillectomy patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in obturator functioning |
At 48 hours and 5 weeks after insertion of prosthesis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in psychological distress and quality of life |
Before surgery and one week after surgery; 48 hours after insertion of prosthesis and five weeks after insertion of prosthesis. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
10/09/2019 |
| 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="7"
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)?
|
|
Brief Summary
|
Surgical obturators are given to maxillectomy patients to help restore the patients eating and speech to near normal levels among other benefits. Conventionally, cold cure/heat cure acrylic resin is used for their fabrication. But patients often complain about unaesthetic display of retentive clasps, compromised retention and leakage of fluid, especially if the defect is large. This study has been designed to fabricate and compare the delayed surgical obturator using vacuum formed thermoplastic sheet with the conventional method in terms of obturator functioning, quality of life and psychological distress as it may be a easier and quicker alternative. |