| CTRI Number |
CTRI/2024/03/063772 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the longevity of zirconia occlusal veneers with lithium di-silicate veneers |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Performance and In-Vitro Survival of Different Surface Treated Monolithic Zirconia Occlusal Veneers with Lithium Di-Silicate Veneers |
| 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
DELHI
110002
India |
| Phone |
9654700952 |
| Fax |
|
| Email |
dr_rekhagupta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhav Raj Dang |
| 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 |
8168441304 |
| Fax |
|
| Email |
vaibhavdang23@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 202, Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
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: K032||Erosion of teeth, (2) ICD-10 Condition: K030||Excessive attrition of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lithium di-silicate occlusal veneers |
Lithium di-silicate occlusal veneers surface treated with 10% hydrofluoric acid |
| Intervention |
Monolithic zirconia occlusal veneers |
Monolithic zirconia occlusal veneers surface treated with 98% sulphuric acid and 50um alumina particles |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Localized or generalized advanced posterior teeth occlusal wear
Good oral hygiene
No active pulpal and peri-apical disease |
|
| ExclusionCriteria |
| Details |
Extensive carious lesions
Poor oral hygiene
Endodontically treated tooth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the clinical performance and also in-vitro
survival of two different surface treated zirconia occlusal veneers with lithium di-silicate occlusal veneers using USPHS criteria |
To compare the clinical performance and also in-vitro
survival of two different surface treated zirconia occlusal veneers with lithium di-silicate occlusal veneers. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the survival of zirconia veneers and lithium di-silicate veneers |
0,3, 6,9 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Brief summary This study is a randomized, single blind, parallel group, trial comparing the clinical performance and also in-vitro survival of two different surface treated zirconia occlusal veneers with lithium di-silicate occlusal veneers, that will be conducted in Maulana Azad Institute of Dental Sciences, New Delhi. The primary outcome will be that monolithic zirconia occlusal veneers with different surface treatments can be used as an acceptable material for fabrication of occlusal veneers. |