Assessment of a New Resin-based Composite Filling Material
NCT ID: NCT00738647
Last Updated: 2011-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2007-05-31
2019-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ceram X
Fillings made with a traditional composite material (Ceram X)
Tooth restorations with composite
The cavity is excavated and filled according to the guidelines for composite restorations
Filtek Silorane
Fillings made with a new composite material (Filtek silorane)
Tooth restorations with composite
The cavity is excavated and filled according to the guidelines for composite restorations
Interventions
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Tooth restorations with composite
The cavity is excavated and filled according to the guidelines for composite restorations
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Malene Schmidt, DDS
Role: PRINCIPAL_INVESTIGATOR
Department of Paediatric Dentistry, School of Dentistry, University of Aarhus
Other Identifiers
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Filtek
Identifier Type: -
Identifier Source: org_study_id