Dental Cervical Non-carious Lesion
Conditions
Brief summary
A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious cervical lesions.
Detailed description
This is a prospective, randomized, monocenter parallel group study on restoration of tooth with non-carious cervical restorations. Each patient receives cervical restoration(s) either with glass hybrid EQUIA forte or with composite resin/adhesive combination Filtek Supreme XT/Clearfil SE Bond in anterior/posterior tooth region. Restorations will be provided by one experienced operator. One of two independent examiners will evaluate the restorations at baseline (1 week after placement), and after 18, and 36 months according to the FDI criteria. Reliability of examination will be assessed on a random sample of 30 restorations.
Interventions
OTHEREquia Forte
Restoration of cavities with a Glasshybrid material (Equia Forte)
OTHERFiltek Supreme XT/Clearfil SE Bond
Restoration of cavities with a composite resin based material after placing an adhesive
Sponsors
GC Europe
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* indication of a restorative treatment for a sclerotic non-carious cervical lesion * lesions should be accessible for treatment and visual-tactile re-evaluation * sufficient moisture control should be possible * cervical margins should be located in dentin whereas the coronal margin should be located in enamel
Exclusion criteria
* allergy/hypersensitivity against any of the used materials * participants should not be systematically ill, disabled, pregnant or participating in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of restorations with a re-intervention per all restorations | 36 months | Number of all restorations with a re-intervention being required per all placed restorations (events/sample) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Restoration score | 36 months | score according to FDI criteria |
| Costs for initial and retreatment | recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months) | Costs incurred for staff and material for initial and re-treatments |
Countries
Germany
Outcome results
None listed