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

NCT ID: NCT01925040

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2022-07-31

Brief Summary

The purpose of this study is to compare the clinical performance of a new resin based filling material to an established resin-based filling material in posterior teeth at 2 different study centers.

Detailed Description

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).

Conditions

Caries; Unsatisfactory or Defective Restoration of Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Venus Pearl

Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.

Group Type: EXPERIMENTAL

Placement of restoration

Intervention Type: DEVICE

Placement of restorations

control resin-based filling material

Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.

Group Type: ACTIVE_COMPARATOR

Placement of restoration

Intervention Type: DEVICE

Placement of restorations

Interventions

Placement of restoration

Placement of restorations

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heraeus Kulzer GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Werner Geurtsen, Prof. Dr.

Role: STUDY_CHAIR

Hannover Medical School

Gabriela Ibarra, DDS, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Werner Geurtsen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical School Hannover

Locations

Oregon Health and Science University-School of Dentistry

Portland, Oregon, United States

Medical School Hannover

Hanover, , Germany

Countries

United States; Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HKG-DT-01/2011-SOCO-CLIN

Identifier Type: -

Identifier Source: org_study_id