Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496126
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-26
Brief Title:
Clinical Comparison of Resin-hybrid Ceramic Restorations Produced Using a Computer-aided DesignComputer-aided Manufacturing CADCAM System With Fiber-reinforced Composite Restorations
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Clinical Comparison of Resin-hybrid Ceramic Restorations Produced Using a Computer-aided DesignComputer-aided Manufacturing CADCAM System With Fiber-reinforced Composite Restorations
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
The aim of this clinical study was to compare the clinical performance of CADCAM endochrone and fibre-reinforced composite restorations in root canal treated teeth with excessive loss
Detailed Description:
Restoration of endodontically treated teeth is one of the significant challenges encountered in dentistry The restoration of these teeth is often confronted with a series of complex factors Following endodontic treatment the coronal structure of the tooth may have been significantly weakened or lost This condition makes it difficult to properly place restorative materials and restore the tooths durability Additionally the weakness or loss of coronal structure after root canal treatment makes it difficult for these teeth to perform their normal functions and withstand chewing forces Consequently the restoration of endodontically treated teeth is a process that requires careful planning by dentists selection of appropriate materials and implementation of suitable techniques
Endocrown restorations and fiber-reinforced composites eg EverX Flow are commonly used options in the restoration of such teeth Endocrown restorations help support the tooth by covering a significant portion of the coronal structure
GC Cerasmart 270 GC Corporation Tokyo Japan is a resin nanoceramic structure containing approximately 71 by weight of nanoceramic particles bonded to a resin matrix Restorations designed digitally can be milled from a milling device for use in the production of restorations With its enhanced strength and wear resistance smooth restorations can be produced limiting both aesthetic appearance and wear of opposing teeth
Fiber-reinforced composites contain glass fibers to increase durability thereby reducing the fragility of teeth after root canal treatment and aiding in preventing cracks EverX Flow is a flowable composite reinforced with short fibers indicated for dentin replacement along with a traditional composite as the enamel layer in direct restorations and core build-ups Due to its short fibers EverX Flow efficiently strengthens restorations and demonstrates high fracture resistance
In each patient one or more endodontically treated teeth will be randomly assigned to be restored using either GC Cerasmart 270 blocks or EverX Flow combined with GC Achord GC Cem One Resin Cement will be used for adhesive procedures in the endocrown group while GC G-Premio Bond will be used in the fiber composite group Restoration procedures will be performed by a single operator Restorations will be evaluated by two calibrated evaluators according to modified USPHS criteria at baseline and at 6 and 12 months Data will be statistically analyzed using chi-square Cochrane and McNemar tests p 005
Endocrown restorations and fiber-reinforced composites eg EverX Flow are commonly used options in the restoration of such teeth Endocrown restorations help support the tooth by covering a significant portion of the coronal structure
GC Cerasmart 270 GC Corporation Tokyo Japan is a resin nanoceramic structure containing approximately 71 by weight of nanoceramic particles bonded to a resin matrix Restorations designed digitally can be milled from a milling device for use in the production of restorations With its enhanced strength and wear resistance smooth restorations can be produced limiting both aesthetic appearance and wear of opposing teeth
Fiber-reinforced composites contain glass fibers to increase durability thereby reducing the fragility of teeth after root canal treatment and aiding in preventing cracks EverX Flow is a flowable composite reinforced with short fibers indicated for dentin replacement along with a traditional composite as the enamel layer in direct restorations and core build-ups Due to its short fibers EverX Flow efficiently strengthens restorations and demonstrates high fracture resistance
In each patient one or more endodontically treated teeth will be randomly assigned to be restored using either GC Cerasmart 270 blocks or EverX Flow combined with GC Achord GC Cem One Resin Cement will be used for adhesive procedures in the endocrown group while GC G-Premio Bond will be used in the fiber composite group Restoration procedures will be performed by a single operator Restorations will be evaluated by two calibrated evaluators according to modified USPHS criteria at baseline and at 6 and 12 months Data will be statistically analyzed using chi-square Cochrane and McNemar tests p 005
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