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

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.

Conditions

• Dental Caries

Interventions

DEVICE

Prime & Bond Universal

Prime \& Bond Universal

DEVICE

Ceram X

DEVICE

Prime & Bond XP

Control

PROCEDURE

technique 1

PROCEDURE

technique 2

Sponsors & Collaborators

• Dentsply International

  collaborator INDUSTRY

• Sheffield Teaching Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Nicolas Martin, Professor · Sheffield Teaching Hospitals NHS FT

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2022-03-31

Completion

2022-03-31

Countries

• United Kingdom

Study Locations