| CTRI Number |
CTRI/2025/04/085720 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two materials for Indirect Occlusal Veneers: A clinical trial |
|
Scientific Title of Study
|
Clinical Evaluation of Indirect Occlusal Veneers made with two different materials- An invivo study |
| 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 Keyur Vala |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital, Ahmedabad |
| Address |
Room no. -9, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Ahmedabad, India, Pin- 380016 Civil Hospital Campus, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India |
| Phone |
9537581009 |
| Fax |
|
| Email |
keyur.vala30797@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nupur Dhanak |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital, Ahmedabad |
| Address |
Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Civil Hospital Campus, Asarwa, Ahmedabad
Ahmadabad GUJARAT 380016 India |
| Phone |
9428198077 |
| Fax |
|
| Email |
bhavsarnupur@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Keyur Vala |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital, Ahmedabad |
| Address |
Room no. -9, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Ahmedabad, India, Pin- 380016 Civil Hospital Campus, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India |
| Phone |
9537581009 |
| Fax |
|
| Email |
keyur.vala30797@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Ahmedabad, India, Pin -380016 |
| Type of Sponsor |
Other [Government Dental College 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 Keyur Vala |
Government Dental College and Hospital, Ahmedabad |
Room no.-9, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Ahemedabad Ahmadabad GUJARAT |
09537581009
keyur.vala30797@hotmail.com |
|
|
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: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clinical Evaluation of Indirect Occlusal veneer made with lithium disilicate at the end of 6 months |
Patients with localized or generalized tooth wear, with complain of sensitivity and chewing difficulty in premolars and molars are considered. Molars or Premolars are prepared with minimally invasive chamfer margin and then restored with Lithium disilicate indirect restorations which are bonded. |
| Comparator Agent |
Clinical Evaluation of Indirect Occlusal veneer made with zirconia reinforced lithium silicate at 6 months |
Patients with localized or generalized tooth wear, with complain of sensitivity and chewing difficulty in premolars and molars are considered. Molars or Premolars are prepared with minimally invasive chamfer margin and then restored with zirconia reinforced Lithium silicate indirect restorations which are bonded.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
(a) Age 18-70 years
(b) Optimal oral hygiene.
(c) Patients with molar-incisor hypomineralization
(d) Patients with attrition, abrasion, erosion and biocorrosion
|
|
| ExclusionCriteria |
| Details |
(a) Patients with poor oral hygiene
(b) Heavy smokers or patients with tobacco chewing
(c) Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Zirconia reinforced lithium silicate will perform better than lithium disilicate |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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="0" Months="6" 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
|
In modern restorative dentistry, the emphasis has shifted toward minimally invasive approaches to manage tooth wear, particularly on occlusal surfaces, while conserving healthy tooth structure. Biocorrosion, caused by chemical, biological, and electrochemical interactions (e.g., dietary acids, GERD), is now a major contributor to tooth wear alongside abrasion and attrition. These conditions can impair aesthetics, reduce vertical dimension, and compromise oral function and quality of life. Historically, full-coverage crowns following elective root canals were the standard treatment, but they involve significant tooth reduction and associated complications. In contrast, partial coverage restorations like inlays, onlays, overlays, and occlusal veneers have emerged as conservative, biomechanically favorable alternatives. Occlusal veneers—also known as tabletop restorations—are especially useful for severe occlusal wear. They preserve enamel and require proper bonding protocols and material selection to ensure long-term success. Among restorative materials: -
Lithium disilicate ceramics (e.g., IPS e.max Press) offer a balance of strength, esthetics, and reliable bonding. -
Zirconia-reinforced lithium silicate ceramics (e.g., Celtra Press) provide enhanced strength and crack resistance with good bonding and optical properties. While promising, most data on material performance come from in vitro studies, and there’s a lack of robust clinical comparisons. Therefore, this study aims to evaluate the clinical performance, survival and complications of lithium disilicate vs. zirconia-reinforced lithium silicate occlusal veneers in vivo. |