NCT04796974

Clinical Evaluation of "Cention Forte" Restorative Material

Clinical Evaluation of "Cention Forte" Restorative Material in Class I and II Cavities: A Prospective Controlled Clinical Trial up to 3 Years

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Istanbul Medipol University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Resin composites, the first choice of material for the restoration of posterior teeth, still have several drawbacks including their polymerization shrinkage and potential failure of the resin-dentin interface leading to secondary caries. Time-saving and simplified restorative procedures are an ongoing demand for posterior applications.The bulk-fill resin based composites (BF-RBCs), has been developed with an attempt to speed up the restoration process by enabling up to 4- or 5-mm thick increments to be cured in one step. The photo-polymerized single-step BF-RBC materials seem to have some limitations in terms of adequate polymerization. Therefore, recently, the use of dual-polymeritzed RBCs that are also suitable for bulk-fill application with additional bioactive properties such as acid-neutralizing ion release has been offered as an alternative to photo-polymerized ones. Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) restorative material is one approach that has been introduced as a new material category for this purpose. The hand mixed form is named as Cention N whereas auto-mixed capsule form is Cention. Both of them are resin based composite materials categorised as 'alkasite'. They are self-curing composites with optional photo-polymerzation for full volume (bulk) placement. Their composition is same with only exception of the concentration of the initiators and the powder liquid proportion. Cention is delivered together with Cention Primer to ensures the retention of the filling independent of the preparation. The objective of this prospective clinical trial is to evaluate the clinical performance of Cention and Cention Primer in restoration of Class I and II cavities.

Detailed description

The aim of the study is to place at least 90 posterior restorations with Cention (in at least 45 patients). The patients will be informed about the study and ask to sign the Informed Consent. After having the initial radiographs and images, the preperation will be performed by standard procedures. As the cavity preparation is finished the measurement of the cavity dimensions will be performed by using a periodontal probe. After having the cavity images the cavity will be restored by Cention according to the manufacturer's instructions. Following the occlusal adjustment final image of the restoration will be taken. After 2 weeks the patient will be recalled in order to asses the baseline FDI criteria by two observers. This recall appointment will be done annually up to 3 years.

Conditions

• Caries
• Unsatisfactory or Defective Restoration of Tooth

Interventions

Type	Name	Description
DEVICE	Cention	Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Basic Filling Material). Procedures will be done using local anesthesia. The cavity is excavated and filled according to the guidelines for ordinary restorative techniques

Timeline

• Start date: 2021-03-08
• Primary completion: 2022-06-08
• Completion: 2025-07-08
• First posted: 2021-03-15
• Last updated: 2024-07-10

Locations

1 site across 1 country: Turkey (Türkiye)