Faculty of Dentistary - Al-Azhar University
Cairo, Egypt
NCT Number: NCT06461364
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.
Looking for future studies?
Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Cairo, Egypt
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 technique/intervention, 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To assess the performance of bulk-fill restorations on premolar teeth in class II cavities using some selected FDI criteria, a total sample size of 30 (10 for each group test) will be sufficient to detect: an effect size of 1.22 at a power (1-β error) of 0.8 and using a two-sided hypothesis test and a significance level (α error) 0.05 for data. Two teeth will be added to each group to compensate drop out samples.
Time frame: from 3 months to 12 months
evaluated surface luster and surface staining
Time frame: from 3 months to 12 months
evaluated fracture of material and retention,occlusal contour and wear
Time frame: from 3 months to 12 months
Biological evaluated post operative hypersensitivity and recurrence caries
Egymedicalpedia
Industry
Evaluation of Cuspal Deflection and Fracture Resistance of Different Bulk-fill Restorations and Their Clinical Performance in Class II Cavities
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07648485
Cavity, Dental, Dental Caries
View Trial DetailsNCT06588725
Behavior, Cavity, Dental
Nashville, Tennessee, United States
View Trial DetailsNCT07718412
Behavior, Dental Caries
Sivas, Merkez, Turkey (Türkiye)
View Trial DetailsNCT07720999
Dental Caries, Neurologic Manifestations
Cairo, Cairo Governorate, Egypt
View Trial Details