Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774614
Status:
UNKNOWN
Last Update Posted:
2021-03-01
First Post:
2021-01-17
Brief Title:
Shade Match Marginal Adaptation and Patient Satisfaction of VITA ENAMIC multiColor Versus IPS eMax CAD Veneers
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Shade Match Marginal Adaptation and Patient Satisfaction of VITA ENAMIC multiColor Versus IPS eMax CAD Anterior Laminate Veneers Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is assumed that there will be no difference in shade match marginal adaptation and patient satisfaction between VITA ENAMIC multiColor and IPS emax CAD anterior laminate veneers
Detailed Description:
Study settings
This study will be carried out on patients enrolled from the Outpatient clinic in fixed prosthodontics clinic Faculty of Oral and Dental Medicine Cairo University
Participant timeline
The patient will be treated in visits designated as follows
1 st Visit Preoperative records face-to-face adherence reminder session clinical radiographic examination and primary impression for diagnostic cast construction
2 nd Visit Teeth preparation secondary impression and temporary restoration
3 rd Visit Try in
4 th Visit Placement and permanent cementation of the final restoration Shade match marginal adaptation and patient satisfaction will be evaluated immediately after cementation
Data collection methods
Primary outcome Shade match will be assessed by using Modified United State Public Health Service Criteria Modified USPHS Criteria
Secondary outcomes
Marginal adaptation will be assessed by modified USPHS criteria Patients satisfaction will be assessed using nominal scores non-acceptable acceptable good and excellent
Data management
All data will be entered electronically in an Excel sheet Patient files are to be stored in numerical order in a secured place
Statistical methods
All Data will be collected checked revised tabulated and entered into the computer
Data will be analyzed using IBM advance statistics Statistics package for social sciences version 21 SPSS inc Chicago IL
Categorical data will be described as numbers and percentage
Data will be explored for normality using Kolmogrov-smirnov test and Shapiro-wilk test
Comparison between two groups for normally distributed numeric variables will be done by Mann-Whitney test An equivalence limit will be tested
A P-value less than or equal to 005 will be considered statistically significant All tests will be two tailed
Data monitoring
Monitoring The main supervisor is responsible of data monitoring if harms arise interim analysis will be done
Harms Any adverse effect like pain or even failure will be recorded documented and treated
Audit Auditing of the study design will be done by the evidence-based committee of the faculty of Oral and Dental medicine at Cairo University
This study will be carried out on patients enrolled from the Outpatient clinic in fixed prosthodontics clinic Faculty of Oral and Dental Medicine Cairo University
Participant timeline
The patient will be treated in visits designated as follows
1 st Visit Preoperative records face-to-face adherence reminder session clinical radiographic examination and primary impression for diagnostic cast construction
2 nd Visit Teeth preparation secondary impression and temporary restoration
3 rd Visit Try in
4 th Visit Placement and permanent cementation of the final restoration Shade match marginal adaptation and patient satisfaction will be evaluated immediately after cementation
Data collection methods
Primary outcome Shade match will be assessed by using Modified United State Public Health Service Criteria Modified USPHS Criteria
Secondary outcomes
Marginal adaptation will be assessed by modified USPHS criteria Patients satisfaction will be assessed using nominal scores non-acceptable acceptable good and excellent
Data management
All data will be entered electronically in an Excel sheet Patient files are to be stored in numerical order in a secured place
Statistical methods
All Data will be collected checked revised tabulated and entered into the computer
Data will be analyzed using IBM advance statistics Statistics package for social sciences version 21 SPSS inc Chicago IL
Categorical data will be described as numbers and percentage
Data will be explored for normality using Kolmogrov-smirnov test and Shapiro-wilk test
Comparison between two groups for normally distributed numeric variables will be done by Mann-Whitney test An equivalence limit will be tested
A P-value less than or equal to 005 will be considered statistically significant All tests will be two tailed
Data monitoring
Monitoring The main supervisor is responsible of data monitoring if harms arise interim analysis will be done
Harms Any adverse effect like pain or even failure will be recorded documented and treated
Audit Auditing of the study design will be done by the evidence-based committee of the faculty of Oral and Dental medicine at Cairo University
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None