| CTRI Number |
CTRI/2025/03/082121 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of enamel wear of antagonist teeth due to polished crowns of monolithic zirconia and lithium disilicate using direct intraoral scanning |
|
Scientific Title of Study
|
Comparison of enamel wear of antagonist teeth between polished crowns of monolithic zirconia and lithium disilicate using direct intraoral scanning: a randomised controlled 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 Shruti Singh |
| Designation |
Master of Dental Surgery student (Post graduate dental student) |
| Affiliation |
Bapuji Dental College and Hospital, Davangere, Karnataka, India |
| Address |
Dr Shruti Singh
PG Student
Department of Prosthodontics and Crown and Bridge
Bapuji Dental College and Hospital, Davangere, Karnataka, India
PIN code- 577004
Davanagere
KARNATAKA
577004
India |
| Phone |
7406172870 |
| Fax |
|
| Email |
shrutisingh1602@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leela B |
| Designation |
Reader |
| Affiliation |
Bapuji Dental College and Hospital, Davangere, Karnataka, India |
| Address |
Department of Prosthodontics and Crown and Bridge
Bapuji Dental College and Hospital, Davangere, Karnataka, India
PIN code- 577004
Davanagere
KARNATAKA
577004
India |
| Phone |
8105957440 |
| Fax |
|
| Email |
drleela82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Singh |
| Designation |
Master of Dental Surgery student (Post graduate dental student) |
| Affiliation |
Bapuji Dental College and Hospital, Davangere, Karnataka, India |
| Address |
Dr Shruti Singh
PG Student
Department of Prosthodontics and Crown and Bridge
Bapuji Dental College and Hospital, Davangere, Karnataka, India
PIN code- 577004
Davanagere
KARNATAKA
577004
India |
| Phone |
7406172870 |
| Fax |
|
| Email |
shrutisingh1602@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shruti Singh
PG Student
Department of Prosthodontics and Crown and Bridge
Bapuji Dental College and Hospital, Davangere, Karnataka, India
PIN code- 577004 |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Singh |
| Address |
Dr Shruti Singh
PG Student
Department of Prosthodontics and Crown and Bridge
Bapuji Dental College and Hospital, Davangere, Karnataka
PIN code- 577004 |
| Type of Sponsor |
Other [Individual] |
|
|
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 Shruti Singh |
Bapuji Dental College and Hospital |
Bapuji Dental College and Hospital, MCC B Block, Davangere, Karnataka, India
PIN code- 577004
Davanagere
KARNATAKA |
7406172870
shrutisingh1602@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bapuji Dental College and Hospital, Davangere, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lithium Disilicate Crowns |
The enamel wear against Lithium Disilicate crowns will be measured for one year |
| Comparator Agent |
Zirconia Crowns |
The enamel wear against Zirconia crowns will be measured |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) For patients who require and are willing to go for tooth-coloured crowns.
2) Restorable teeth in need of full veneer crowns with respect to either maxillary or mandibular first molars.
3) Fair oral hygiene and Periodontal status.
4) Dental and Skeletal Class I Molar relation.
5) Patients available for follow-up after 6 months and 12 months of crown cementation. |
|
| ExclusionCriteria |
| Details |
1) Systemic, medical compromising, calcium or metabolic conditions which may affect research.
2) Missing antagonist teeth.
3) Untreated carious antagonist teeth.
4) Periodontally compromised teeth.
5) Grossly attrited antagonist teeth (ASA III and ASA IV).
6) Occlusal restorations with respect to antagonist teeth.
7) Developmental defects affecting enamel and/or dentin.
8) Parafunctional Habits (bruxism, bruxomania, clenching).
9) TMJ disorders or antagonist plunger cusps.
10) Antagonist prosthetic crowns.
11) Diet with high titrable acidity.
12) Habits of unilateral mastication.
13) Tobacco chewing habits. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enamel wear wrt antagonist teeth |
6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To choose which crowns are better, measurement being direct intraoral measurement |
6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
1. To assess enamel wear of antagonist teeth against polished monolithic zirconia crown using direct intraoral scanning. 2. To assess enamel wear of antagonist teeth against polished lithium disilicate crown using direct intraoral scanning. 3. To compare enamel wear of antagonist teeth between polished crowns of monolithic zirconia and lithium disilicate using direct intraoral scanning. |