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

Completed · Not applicable

Conditions studied: Caries, Unsatisfactory or Defective Restoration of Tooth

In brief

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.

Key facts

Study ID

NCT01925040

Run by

Heraeus Kulzer GmbH

People needed

130

Starts

2013-06-01

Expected to finish

2022-07-01

Last updated by the study team

2024-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Oregon Health and Science University-School of Dentistry — Portland, Oregon, United States
• Medical School Hannover — Hanover, Germany

Full record on ClinicalTrials.gov

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