Assessment of a New Resin-based Composite Filling Material

Caries Clinical Trial

Official title:

Assessment of a New Resin-based Composite Restorative Material

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00738647
• Other study ID #: Filtek
• Status: Active, not recruiting
• Phase: N/A
• First received: August 19, 2008
• Last updated: November 4, 2011
• Start date: May 2007
• Est. completion date: August 2019

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: August 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Poor oral hygiene or teeth needing endodontic treatment.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caries
• Restoration Defects

Intervention

Procedure:
• Tooth restorations with composite
The cavity is excavated and filled according to the guidelines for composite restorations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Adaptation		1 year	No