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Clinical Study Class II on Ceram.x Universal and Prime&Bond

Dental Caries Clinical Trial

Official title:
Clinical Post-Market Surveillance Study of Ceram.x Universal and Prime&Bond Universal When Used for Class II Restorations at the University of Sheffield

Clinical Trial Summary

Damage to teeth from decay or previous old silver fillings can be repaired with tooth-coloured filling materials that stick to the tooth. These materials have been around for some years and have become more sophisticated; with greater ease of placement by the dentist and better durability for the patient. The fillings are designed to be used in combination with a specific glue (adhesive) that is designed to stick to the different parts of the tooth to provide a good seal, the outer enamel and the inner dentine. This study will examine the performance of a state-of-the-art modern tooth coloured filling material (Ceram X) in combination with an existing adhesive (control adhesive) and a new adhesive (Prime & Bond Universal) used in two different techniques; both of which are known to work but one is easier to apply. This results in three treatment groups. At the start of the study, the test material Prime&Bond Universal is CE-marked, as are all other medical devices used. Thus, this study is not conducted to meet any regulatory requirements. The rationale of this study is the extension of knowledge primarily concerning the clinical performance of Prime&Bond Universal in molars. Two investigators (to be confirmed) will place a minimum of 25 restorations per group (75 restorations in total) to assess the performance of the materials in a comparative design. The study restorations will be monitored for a period of 18 months (with the option to extend the evaluation period to 48 months). After placement of restorations under controlled clinical conditions, the primary objective of the study is the determination of post-operative sensitivity and pulp vitality, marginal adaptation and staining of margins of the restorations. In addition, fracture of material and retention, recurrent caries, occlusal contour and wear, approximal anatomical form will be determined as well as the failure rate as defined by the ADA.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02991573
Study type Interventional
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact
Status Completed
Phase N/A
Start date November 2015
Completion date March 31, 2022
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