Dental Caries, Dental Restoration Failure
Conditions
Keywords
Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Composite resin
Brief summary
The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.
Detailed description
In this post-market prospective randomized controlled clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. The bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.
Interventions
DEVICEFiltek One
Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.
DEVICEFiltek Z250
Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.
Sponsors
3M
Louisiana State University Health Sciences Center in New Orleans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double blind (Subject, Investigator, Outcomes Assessor)
Intervention model description
In a split-mouth design, each participant will receive 2 matched restorations, one of each material.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be older than 18 years of age * have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings * both study teeth must be vital (tested with cold) * both study fillings must be visible on the cheek-side of the tooth.
Exclusion criteria
* do not meet all inclusion criteria * are under active orthodontic treatment * have severe medical complications * have dry mouth * have chronic gum disease or poor oral hygiene * are unavailable for long term recall (minimum of 2 years required) * cannot tolerate the rubber dam * have an unstable tooth contacts * have severe bruxing or clenching, or are in need of jaw joint therapy * are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with restoration failure of either material | 2 years | Restoration failure is based on clinical performance criteria according to the Fédération Dentaire Internationale (FDI) rating system. An assessment of score 5, indicating poor performance, in any of the three categories esthetic, functional or biological performance will be considered a failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance score for each restoration | 2 years | Quality rating for each restoration/material based on the FDI clinical performance scores (1-5) for the three categories esthetic, functional and biological performance. |
| Confirmation of material safety | 2 years | Number of participants with unanticipated treatment-related Adverse Events as assessed by • Fatal, • Persistent disability or significant incapacity, • Congenital anomaly/birth defect or cancer, • Life-Threatening, • Associated with overdose, • Required hospital admission or prolongation of hospitalization (Adverse Events Reporting Requirements LSUHSC-NO IRB). |
Countries
United States
Outcome results
None listed