Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457737
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-03
Brief Title:
The Performance of Posterior Partial Coverage Coronal Restorations Luted With Two Differrent Systems
Sponsor:
King Abdullah University Hospital
Organization:
King Abdullah University Hospital
Study Overview
Official Title:
The Performance of Posterior Partial Coverage Coronal Restorations Cemented Using Two Different Luting Systems A Comparative Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth It will follow a split-mouth design with 60 participants selected based on strict criteria Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria evaluating retention color match marginal discoloration secondary caries anatomical form marginal adaptation and surface roughness
The null hypothesis
The use of preheated resin composite for cementing partial coverage restoration will not result in significantly superior clinical performance when compared to that after using dual-cure resin cement
The null hypothesis
The use of preheated resin composite for cementing partial coverage restoration will not result in significantly superior clinical performance when compared to that after using dual-cure resin cement
Detailed Description:
The adhesive cementation of ceramic partial coverage restorations is a technique-sensitive process essential for achieving optimal retention and marginal integrity While dental resin cements are commonly used for adhesive luting of indirect ceramic restorations concerns exist regarding their long-term reliability due to susceptibility to degradation over time and polymerization shrinkage-related issues
This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth aiming to address these drawbacks It will follow a split-mouth design with 60 participants selected based on strict criteria The preparation and delivery appointments follow specific guidelines incorporating the Morphology Driven Preparation Technique MDPT Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria evaluating retention color match marginal discoloration secondary caries anatomical form marginal adaptation and surface roughness
The objectives of this clinical trial are to evaluate the clinical performance of posterior partial coverage coronal restorations utilizing two different luting systems preheated resin-based composite versus conventional dual-cure resin cement in a split-mouth study design
This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth aiming to address these drawbacks It will follow a split-mouth design with 60 participants selected based on strict criteria The preparation and delivery appointments follow specific guidelines incorporating the Morphology Driven Preparation Technique MDPT Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria evaluating retention color match marginal discoloration secondary caries anatomical form marginal adaptation and surface roughness
The objectives of this clinical trial are to evaluate the clinical performance of posterior partial coverage coronal restorations utilizing two different luting systems preheated resin-based composite versus conventional dual-cure resin cement in a split-mouth study design
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