CariesNCT00738647
Assessment of a New Resin-based Composite Filling Material
A study testing Tooth restorations with composite in people with Caries and Restoration Defects, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Restoration Defects
- What is being tested?
- Tooth restorations with composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients registered for treatment with a posterior multi surface composite restoration.
Who cannot join
- Poor oral hygiene or teeth needing endodontic treatment.
About this study
Official title: Assessment of a New Resin-based Composite Restorative Material
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.
Read the 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.
- Conditions
- Caries, Restoration Defects
- Being tested
- Tooth restorations with composite
- Keywords
- Filling materials, Restorative materials, clinical trial, Resin based composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth restorations with compositeProcedure or surgery
The cavity is excavated and filled according to the guidelines for composite restorations
| Study group | Role | What they receive |
|---|---|---|
| Ceram X | Active comparator | Fillings made with a traditional composite material (Ceram X) Receives: Procedure: Tooth restorations with composite |
| Filtek Silorane | Experimental | Fillings made with a new composite material (Filtek silorane) Receives: Procedure: Tooth restorations with composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Adaptation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startMay 2007
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malene Schmidt, DDS, Principal investigator, Department of Paediatric Dentistry, School of Dentistry, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738647
- Sponsor's protocol ID
- Filtek
- Status last verified
- Nov 2011
- First submitted
- 19 Aug 2008
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New Resin-based Composite Restorative Material
- ClinicalTrials.gov ID
- NCT00738647
- Acronym / sponsor ID
- Filtek
- Conditions
- Caries, Restoration Defects
- Keywords
- Filling materials, Restorative materials, clinical trial, Resin based composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceram X | Active comparator | Procedure: Tooth restorations with compositeFillings made with a traditional composite material (Ceram X) |
| Filtek Silorane | Experimental | Procedure: Tooth restorations with compositeFillings made with a new composite material (Filtek silorane) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients registered for treatment with a posterior multi surface composite restoration.
Key exclusion criteria (1 listed)
- Poor oral hygiene or teeth needing endodontic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth restorations with compositeThe cavity is excavated and filled according to the guidelines for composite restorations | Procedure or surgery | Ceram X, Filtek Silorane |
Primary outcome
Marginal Adaptation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malene Schmidt, DDS principal investigator
Department of Paediatric Dentistry, School of Dentistry, University of Aarhus
Questions about this trial
What is this clinical trial studying?
A study testing Tooth restorations with composite in people with Caries and Restoration Defects, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal Adaptation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011.