The objective of the study is to evaluate the clinical survival and quality parameters of posterior composite resin restorations made with Filtek Bulk Fill Posterior Restorative over a follow-up period of five years and to compare it with data yielded from intra-individual control restorations (split-mouth) made of Filtek Supreme XTE.
Conditions
Interventions
Group 1: Insertion of a class-II composite resin restoration using Filtek Bulk Fill Posterior Restorative following a standardized treatment protocol.
Group 2: Insertion of a class-II composite resin
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subject Inclusion Criteria • Male or female patients diagnosed for restorative treatment using composite resin restorations on two or more posterior teeth (molars, premolars) • Aged 18 – 80 • Good general health Restoration Inclusion Criteria • Class-II restoration on posterior tooth (molars, premolars) • Restoration with antagonist and at least one proximal contact • Good prognosis of tooth – 5 year survival of tooth can be expected • Class II restoration requiring replacement of one cusp are only included if both Class II restorations of the same individual require replacement of one cusp
Exclusion criteria
Exclusion criteria: Subject Exclusion Criteria • Patient is pregnant or nursing • Dental personnel or dental student • Severely neglected oral hygiene • Disabilities or reduced manual dexterity that may interfere with normal oral hygiene procedures Restoration Exclusion Criteria • Severe periodontal disease (Periodontal Community Screening Index Grade 4, i.e. periodontal probing depth =6mm) on tooth to be treated • Extensive tooth substance loss requiring replacement of more than one cusp • Pulpitic pain before treatment or pulp exposure during treatment • Non-vital teeth • Signs of parafunctions / bruxism • Known allergies against any of the study substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival of restorations after 1, 2, 3 and 5 years. Definition of overall survival: Restorations which are in-situ and completely intact at follow-up will be recorded as overall survival (score 1 through 3 in all categories of the Hickel/FDI criteria). In case any type of failure (score 5) or unfavorable event (score 4) happened during the follow-up period the restoration will be classified as a failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality parameters of restorations Definition of quality parameter: FDI clinical criteria and scoring system. | — |
Countries
Germany
Contacts
Public ContactKyrill Schoilew
Poliklinik für ZahnerhaltungskundeKlinik für Mund-, Zahn- und KieferkrankheitenUniversitätsklinikum Heidelberg
Outcome results
None listed