Assessment of a New Resin-based Composite Restorative Material
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Aarhus
- Enrollment
- 72
- Primary Endpoint
- Marginal Adaptation
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- 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.
Arms & Interventions
Ceram X
Fillings made with a traditional composite material (Ceram X)
Intervention: Tooth restorations with composite (Procedure)
Filtek Silorane
Fillings made with a new composite material (Filtek silorane)
Intervention: Tooth restorations with composite (Procedure)
Outcomes
Primary Outcomes
Marginal Adaptation
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported