Comparison of 2 Different Resin Based Filling Materials in Posterior Teeth - a Multicenter Study

The objective of this study is to compare the performance of the composite resin Venus Pearl
and a commercially available control composite material for the restoration of class
II-cavities. Primary endpoints of the study are a mean score for each patient calculated
from aesthetic, functional attribute and biological parameters. Secondary endpoints are the
evaluation of secondary caries, plaque accumulation and gingival reactions and the
comparison of the primary score at week 1, month 6, month 12 and month 24 after restoration.
Beside this, the single components of the three categories of the primary endpoints will be
compared. The study will be executed as a multi-center (Oregon Health & Science University,
Portland, OR, USA and Medical School Hannover, Hannover, Germany), single-blinded and
randomized clinical investigation. 90 comparable cavities per study site will be treated (45
cavities for each material at each site).

Inclusion Criteria:

- Patients should be 18 years and older.

- Study teeth should have an interproximal (Class II) carious lesion or an existing
defective class II restoration requiring restorative therapy on premolars or molars.

- The maximum cavity depth determined by the radiograph will be D2 (Tyas
classification).

- The teeth included in the study need to have a proximal contact with the adjacent
tooth and be in occlusion with the opposing dentition.

- The teeth included in the study should be vital with no signs of pulpal pathology.

- Patients that report brushing regularly without severe gingival inflammation and/or
extensive caries.

- Patients should have no allergies or systemic diseases which inhibit the treatment.

- Patients should have voluntary participation and sign a written informed consent
form.

- Patients should be willing to participate in the recall/re-examination appointments.

Exclusion Criteria:

- Simultaneous participation in another study about dental restorative materials.

- Written informed consent form not signed.

- Nonvital pulp / periapical lesion.

- Insufficient oral hygiene despite detailed instructions.

- Pregnancy/ breast feeding before placement of the study restoration.

- Minors.

- Severe malocclusion/ malalignment/ traumatic occlusion/ bruxism.

- Known allergy to any components present in any of the materials that are used for
this study.

- Unclear mucosal alterations, e.g. oral lichenoid reactions/lesions.

- Severe medical complications (organ transplants, cancer, immune-compromised,
long-term antibiotic or steroid therapy).

- Infectious diseases such as HIV/Aids, Hepatitis, etc.

- Application of bleaching products less than 14 days before placement of the
restoration.

- Orthodontic treatment during the study.

- Xerostomia.

- Untreated periodontal diseases.

- Rampant or extensive caries present.

- Systemic diseases with potential oral manifestation.

- Sufficient isolation according to the criteria of adhesive techniques not possible,
e.g. application of rubber dam.

- Direct adhesive restoration not indicated.

- Replacement of more than one cusp indicated.

- Dental fears patients.