Ignite Creation Date:
2024-05-06 @ 2:44 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02110550
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2014-04-07
Brief Title:
Evaluation of a New Design of Crowns in the Posterior Teeth
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Evaluation of IPS EMax-CAD Endocrown in Molars Compared to the Conventional Design
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
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:
Background no randomized controlled trial has tried to compare treatment outcomes between the IPSemmax endocrowns and the IPSemmax conventional crowns
Objective to investigate the clinical performance of the IPSemmax endocrowns and the IPSemmax conventional crowns Design and setting Parallel-groups randomized controlled trial on patients with one or more intensive damaged molars requiring crowning and being treated at the University of Damascus Dental School in Damascus Syria All molars will be examined at the baseline assessment using a modified US Public Health Service USPHS criteria
Participants Incoming patients to the Fixed Prosthetic and Endodontic Departments will be examined to find any excessively damaged molars requiring crowning Forty patients will be recruited according to specific inclusion criteria Randomization will be performed using computer-generated tables allocation will be concealed using sequentially numbered opaque and sealed envelopesThe included 40 patients will be analyzed age range between 20-60 years They will be randomly distributed into two groups with 20 patients in each group 11 allocation ratio
Intervention Excessively damaged and endodontically treated molars will be restored with IPSemmax endocrowns or IPSemmax crowns supported with composite core
Main outcome measure marginal adaptation and anatomic form will be investigated clinically and by apical radiographs at the baseline assessment using the modified USPHS at six assessment times during an 18-month observation period
Assessor blinding will be employed
Objective to investigate the clinical performance of the IPSemmax endocrowns and the IPSemmax conventional crowns Design and setting Parallel-groups randomized controlled trial on patients with one or more intensive damaged molars requiring crowning and being treated at the University of Damascus Dental School in Damascus Syria All molars will be examined at the baseline assessment using a modified US Public Health Service USPHS criteria
Participants Incoming patients to the Fixed Prosthetic and Endodontic Departments will be examined to find any excessively damaged molars requiring crowning Forty patients will be recruited according to specific inclusion criteria Randomization will be performed using computer-generated tables allocation will be concealed using sequentially numbered opaque and sealed envelopesThe included 40 patients will be analyzed age range between 20-60 years They will be randomly distributed into two groups with 20 patients in each group 11 allocation ratio
Intervention Excessively damaged and endodontically treated molars will be restored with IPSemmax endocrowns or IPSemmax crowns supported with composite core
Main outcome measure marginal adaptation and anatomic form will be investigated clinically and by apical radiographs at the baseline assessment using the modified USPHS at six assessment times during an 18-month observation period
Assessor blinding will be employed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None