3 year post market clinical follow-up study
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
dental research
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of restoration survival based on the FDI Criteria.
Secondary outcome
Evaluation of restoration quality based on the FDI Criteria and evaluation of
potential adverse effects.
Background summary
Resin composites are widely used as direct restorative materials for the
restoration of tooth decay. Regular composites have to be applied in several
layers to minimize possible shrinkage. Continuous advancements in the field of
3M restoratives have led to the development of an aesthetic bulk fill material
that can be used for stress bearing Class II restorations. The material is a
new composite resin material with nanofiller technology and two innovative
methacrylate monomers for lower polymerization stress. The restoration can be
applied within one layer, which results in a shorter treatment time. In this
clinical study, the use of this new material for Class II restorations will be
evaluated during a period of 3 years.
Study objective
3 year post market clinical follow-up study
Study design
This prospective non-controlled clinical study aims to evaluate the treatment
of decayed teeth with a newly developed esthetic bulk fill material for Class
II restorations.
Intervention
The intervention of the study is treatment of a Class II restoration with a new
bulk fill material.
Study burden and risks
Insertion of direct restorations is a standard method in today*s dentistry.
Filtek One Bulk Fill is CE marked and thus can be used for routine clinical
treatment. A benefit of using composite for restoration of teeth is the
preservation of tooth substance due to limited invasiveness when compared to
alternative treatment methods (inlay, onlay, partial crown, crown). There are
no additional risks beyond those present during routine clinical restorative
treatment to be expected when using the restorative materials. All subjects
will be evaluated at baseline and after 6, 12, 24 and 36 months. This will
require additional visits. During these visits, the restorations will be
clinically examined and documented according to the FDI criteria. A digital
light photograph from occlusal view prior to restoration placement and at every
evaluation will be taken. At baseline and after 24 months, an impression will
be taken.
ESPE Platz x
Seefeld 82229
DE
ESPE Platz x
Seefeld 82229
DE
Listed location countries
Age
Inclusion criteria
- Subject is between 18 and 70 years of age
- Subject is in good general health and can be classified as ASA 1 or 2
- Subject is in need of at least one Class II restoration without cusp
replacement. The restoration can be a replacement of a failed existing
restoration
- Study teeth must have a good prognosis for the next 3 years (no increased
tooth mobility, periodontal probing depth is * 5 mm, no signs of pulpitis, no
pulp exposure during treatment, study teeth are vital, level of oral hygiene is
sufficient)
- Each study restoration has at least one proximal contact and is stress bearing
- Subject volunteers to participate in the study and is available for recalls
during the 3 years study duration
Exclusion criteria
- Subject does have known allergies against any study substances
- Study teeth with bad prognosis (increased tooth mobility, periodontal probing
depth is > 5 mm, signs of pulpitis, pulp exposure during treatment, non-vital
teeth, level of oral hygiene is insufficient)
- Subject undergoing treatment for bruxism, traumatic malocclusion, or erosion
- Study teeth with pulp exposure
- Subject being pregnant or breast feeding
- Subject participating in other dental studies that might interfere with this
study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61285.029.17 |