| CTRI Number |
CTRI/2024/03/064627 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of wear of natural tooth opposing crowns of different materials |
|
Scientific Title of Study
|
In Vivo Evaluation Of Wear Of Natural Enamel
Antagonist To Monolithic Zirconia, Monolithic Lithium Disilicate And Lithium Disilicate Layered PEEK Crowns
|
| 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 Shivani Anand |
| Designation |
PG student |
| Affiliation |
panjab university |
| Address |
Dr Harvansh Singh judge institute of dental sciences and hospital
room no 126 department of prosthodontics
Chandigarh
CHANDIGARH
160014
India |
| Phone |
7838866258 |
| Fax |
|
| Email |
Shivanianand2510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit kumar |
| Designation |
Associate Professor |
| Affiliation |
panjab university |
| Address |
Dr Harvansh Singh judge institute of dental sciences and hospital
room no 126 department of prosthodontics
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9914419876 |
| Fax |
|
| Email |
drlalitbida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalit kumar |
| Designation |
Associate Professor |
| Affiliation |
panjab university |
| Address |
Dr Harvansh Singh judge institute of dental sciences and hospital
room no 126 department of prosthodontics
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9914419876 |
| Fax |
|
| Email |
drlalitbida@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shivani Anand (self)
Dr harvansh singh judge institute of dental science room no 126 department of prosthodontics |
|
|
Primary Sponsor
|
| Name |
Dr Shivani Anand |
| Address |
Dr Harvansh Singh judge institute of dental sciences & hospital |
| Type of Sponsor |
Other [self] |
|
|
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 Shivani Anand |
Department of prosthodontics room no 126 |
Dr Harvansh Singh judge institute of dental sciences and hospital
Chandigarh
CHANDIGARH |
07838866258
Shivanianand2510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Punjab university institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient needing crown on 2nd premolar and 1st molar of any arch having opposing natural enamel |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
contralateral natural tooth of the same patient with follow up for 9 months |
contralateral natural tooth of the same patient |
| Intervention |
crown with follow up for 9 months |
material including monolithic zirconia, monolithic lithium disilicate, and peek layered with lithium disilicate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Subjects needing a crown on either 2nd Premolar or 1st molar of any arch.
b) Subjects having normal Class I Angle’s occlusion.
c) Presence of natural antagonist against the proposed full coverage restoration.
d) Presence of same tooth on the contralateral side with natural antagonist for comparative analysis.
e) Subjects with similar facial biotype.
|
|
| ExclusionCriteria |
| Details |
a) Subjects with parafunctional habits, for example bruxism.
b) Subjects with temporomandibular joint disorder and habit of unilateral mastication.
c) Subjects likely to shift out of the area within the 6 months duration of the study.
d) Subjects with excessive wear of posterior teeth i.e. dentinal exposure.
e) Subjects with restored antagonist tooth opposing the test group tooth or the contralateral side tooth.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
)To evaluate the wear of natural enamel antagonist to -:
I) Monolithic lithium disilicate crown
II) Monolithic zirconia crowns
III) PEEK coping layered with lithium disilicate crowns
|
baseline, 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare wear of natural enamel antagonist to above restorative crowns with enamel to enamel wear on contralateral side in same pair of opposing teeth. |
baseline, 9 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
02/04/2024 |
| 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 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
|
To evaluate the wear of natural enamel antagonist to monolithic zirconia, monolithic lithium disilicate and lithium disilicate layered PEEK restorations and wear of natural enamel antagonist to respective contralateral natural teeth. |