Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Assessment of a New Resin-based Composite Filling Material

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: August 19, 2008
Last updated: November 4, 2011
Last verified: November 2011

Evaluation of a new resin-based composite material.

Amalgam and composite are the most commonly used restorative materials in dentistry. Due to the toxicity of mercury and the subsequent environmental problems, the search for alternatives continues and search into new composite restorative materials intensifies. The presently available composites have improved, but shrinkage of the composite during the curing procedure is still a clinical problem. A new composite restorative material has among other advantages demonstrated lower shrinkage in laboratory studies, due to a new formulation of the material.

This project aims to study the clinical performance of this new composite compared to a commonly used composite restoration material. 72 patients (158 teeth) are allocated to the project which is carried out at the School of dentistry, University of Aarhus, Denmark.

Condition Intervention
Restoration Defects
Procedure: Tooth restorations with composite

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of a New Resin-based Composite Restorative Material

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Marginal Adaptation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: May 2007
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ceram X
Fillings made with a traditional composite material (Ceram X)
Procedure: Tooth restorations with composite
The cavity is excavated and filled according to the guidelines for composite restorations
Experimental: Filtek Silorane
Fillings made with a new composite material (Filtek silorane)
Procedure: Tooth restorations with composite
The cavity is excavated and filled according to the guidelines for composite restorations

Detailed Description:

This project aims to study the clinical performance of a new composite restoration material (Filtek Silorane®) compared to a conventional composite restoration material (Ceram X®).

Amalgam and composite are the most commonly used restorative materials, with the number of composite restorations increasing over the past 20 years. Composite restorative materials have improved considerably over the years. They have almost reached the same resistance to wear as amalgam, and are as a consequence now also used for molar restorations.

The main reasons for replacing composite restorations are fractures and caries associated with the restorations.

To reduce the risk of caries a new composite material Filtek Silorane® with reduced polymerization shrinkage has been developed.

Extensive laboratory studies have been performed on the new material, but the clinical attributes have yet to be disclosed.

The study will be carried out as a randomized, double blinded, longitudinal study, with assessment of the restorations after one year.

The project includes 72 patients, 158 teeth. Most of the patients have been recruited from the Treatment Planning Clinic at the dental school in Aarhus. After giving their consent to take part in the study, the teeth are randomized into two treatment groups. Multi surface restorations of both upper and lower molars and premolars are performed

The treatment procedure is:

The patients are offered local anesthetic before treatment start. The cavity is excavated and filled according to the guidelines for composite restorations. An impression of the cavity is taken before and after it has been filled. After treatment bw-radiographs are taken.

The control procedure is:

The restoration is evaluated according to marginal adaptation, cavo surface marginal discoloration, approximal contact, fractures, caries associated with restorations and postoperative hypersensitivity. The controls will take place after three weeks and one year.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients registered for treatment with a posterior multi surface composite restoration.

Exclusion Criteria:

  • Poor oral hygiene or teeth needing endodontic treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00738647

Sponsors and Collaborators
University of Aarhus
Principal Investigator: Malene Schmidt, DDS Department of Paediatric Dentistry, School of Dentistry, University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus Identifier: NCT00738647     History of Changes
Other Study ID Numbers: Filtek
Study First Received: August 19, 2008
Last Updated: November 4, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Filling materials
Restorative materials
clinical trial
Resin based composite processed this record on February 25, 2015