| CTRI Number |
CTRI/2025/06/089579 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| 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 study comparing how well three types of tooth covers with different surface treatments work over time |
|
Scientific Title of Study
|
Evaluation of clinical performance of three differently surface treated monolithic zirconia occlusal veneers. A randomised controlled clinical trial |
| 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 Rekha Gupta |
| Designation |
Professor and Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room- 215,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 |
Dr Rekha Gupta |
| Designation |
Professor and Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room- 215,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 |
Dr Vasudaa T A |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room- 224,Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9789871762 |
| Fax |
|
| Email |
vasudaa.anandan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Institute of Dental Sciences |
| Address |
Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi |
| 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 204, 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 Maulana Azad Institute of Dental Sciences, New Delhi (Govt of NCT of Delhi) |
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 |
Sandblasting Group |
Monolithic zirconia occlusal veneers surface treated with 50µm alumina particles sandblasting |
| Intervention |
Spray liner Group |
Monolithic zirconia occlusal veneers surface treated with lithium-disilicate spray liner |
| Comparator Agent |
Sulphuric acid Group |
Monolithic zirconia occlusal veneers surface treated with 98% sulphuric acid |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 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
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Monolithic zirconia occlusal veneers with three different surface treatments:
(1) 50µm alumina particles sandblasting, (2) Lithium-disilicate spray liner,
(3) 98% sulphuric acid |
At time of cementation, 3,6 and 9 months after cementation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical performance of Monolithic zirconia occlusal veneers with 50µm alumina particles sandblasting |
At time of cementation, 3,6 and 9 months after cementation |
| To evaluate clinical performance of Monolithic zirconia occlusal veneers with Lithium-disilicate spray liner |
At time of cementation, 3,6 and 9 months after cementation |
| To evaluate clinical performance of Monolithic zirconia occlusal veneers with 98% sulphuric acid |
At time of cementation, 3,6 and 9 months after cementation |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This randomized controlled clinical trial evaluates the clinical performance of three different surface-treated monolithic zirconia occlusal veneers in posterior teeth. Patients will be assigned into three groups receiving different surface treatments, and clinical performance will be assessed at multiple follow-up intervals using the modified USPHS criteria. |