Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461364
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-09
Brief Title:
Clinical Performance of Bulk-fill Restorations in Class II Cavities
Sponsor:
Egymedicalpedia
Organization:
Egymedicalpedia
Study Overview
Official Title:
Evaluation of Cuspal Deflection and Fracture Resistance of Different Bulk-fill Restorations and Their Clinical Performance in Class II Cavities
Status:
COMPLETED
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:
Direct composite resin restorations are considered an essential treatment option in the dental clinic because of increasing the demands for esthetics These materials are primarily used as anterior and posterior filling materials for the restoration of dental caries crown fractures tooth wear and congenital defects
Detailed Description:
It has been reported that the polymerization shrinkage and its associated contraction stress are the greatest limitation in the use of resin-based composite RBC as a restorative material for posterior teeth
Shrinkage stress that is generated due to the polymerization reaction is known as a multifaceted complicated condition There are many factors aiding to development of the rate of shrinkage stress such as material formulation degree of conversion polymerization kinetics flow capacity in the early stages of the curing reaction and elastic modulus of the material itself
Shrinkage stress appear in the form of several manifestations as cuspal movement which can result in enamel micro cracks cervical marginal gaps creating postoperative sensitivity discoloration of the margins recurrent caries breakages of the restoration and finally replacement of composite restorations
New types of restorative materials called bulk-fill restorative materials have been introduced to reduce time required for placement These materials can be placed in bulk layer up to 4-5mm with adequate polymerization and low polymerization shrinkage stress However little information is available regarding the effect of these restorative materials on cuspal deflection
The first thermoviscous bulk-fill composite has the viscosity of a flowable composite and the sculptability of a packable composite all in a single material Prior to placement this material is warmed in a modified caps warmer Bulk-fil composite satisfies the sealing of the proximal box as well as attains the desired anatomy in a single bulk-cure product in class II restorations
Cuspal deflection is a common biomechanical phenomenon that occurs in teeth restored with composite resin-based materials and represents the interaction between polymerization stress of material and the compliance of remaining tooth structure which may cause failure during composite curing or act as a preloading facilitating tooth fracture under occlusal loads Cuspal deflection can be perceived clinically by the patient as postoperative sensitivity
The fracture of teeth is a common dental problem Many factors such as tooth anatomy contribute to cusp fracture however cavity preparation procedures seem to be the major cause of most cuspal fractures Posterior teeth particularly premolars have an anatomic shape that makes them more likely to fracture under occlusal load whereas sound teeth are rarely fracture under normal masticatory function Several studies have emphasized the importance of maintaining dental structure to preserve the strength of remaining tooth Generally the wider the involvement by caries or cavity preparation the weaker the tooth
The FDI criteria-based proposal allows to classify the evaluation of dental restorations according to functional biological and aesthetic categories Their use was thus recommended in clinical trials assessing dental restorations in terms of materials operative techniqueintervention as well as in clinical practice to determine whether a restoration should be maintained repaired or replaced One study compared the FDI criteria and the traditional United States Public Health Service USPHS also known as Ryge criteria criteria for the evaluation of dental restorations
Shrinkage stress that is generated due to the polymerization reaction is known as a multifaceted complicated condition There are many factors aiding to development of the rate of shrinkage stress such as material formulation degree of conversion polymerization kinetics flow capacity in the early stages of the curing reaction and elastic modulus of the material itself
Shrinkage stress appear in the form of several manifestations as cuspal movement which can result in enamel micro cracks cervical marginal gaps creating postoperative sensitivity discoloration of the margins recurrent caries breakages of the restoration and finally replacement of composite restorations
New types of restorative materials called bulk-fill restorative materials have been introduced to reduce time required for placement These materials can be placed in bulk layer up to 4-5mm with adequate polymerization and low polymerization shrinkage stress However little information is available regarding the effect of these restorative materials on cuspal deflection
The first thermoviscous bulk-fill composite has the viscosity of a flowable composite and the sculptability of a packable composite all in a single material Prior to placement this material is warmed in a modified caps warmer Bulk-fil composite satisfies the sealing of the proximal box as well as attains the desired anatomy in a single bulk-cure product in class II restorations
Cuspal deflection is a common biomechanical phenomenon that occurs in teeth restored with composite resin-based materials and represents the interaction between polymerization stress of material and the compliance of remaining tooth structure which may cause failure during composite curing or act as a preloading facilitating tooth fracture under occlusal loads Cuspal deflection can be perceived clinically by the patient as postoperative sensitivity
The fracture of teeth is a common dental problem Many factors such as tooth anatomy contribute to cusp fracture however cavity preparation procedures seem to be the major cause of most cuspal fractures Posterior teeth particularly premolars have an anatomic shape that makes them more likely to fracture under occlusal load whereas sound teeth are rarely fracture under normal masticatory function Several studies have emphasized the importance of maintaining dental structure to preserve the strength of remaining tooth Generally the wider the involvement by caries or cavity preparation the weaker the tooth
The FDI criteria-based proposal allows to classify the evaluation of dental restorations according to functional biological and aesthetic categories Their use was thus recommended in clinical trials assessing dental restorations in terms of materials operative techniqueintervention as well as in clinical practice to determine whether a restoration should be maintained repaired or replaced One study compared the FDI criteria and the traditional United States Public Health Service USPHS also known as Ryge criteria criteria for the evaluation of dental restorations
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