Clinical Performance of Posterior Composite Tooth Fillings in Adults

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.

Detailed Description
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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.

Official Title
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Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects

Conditions
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Dental Caries, Dental Restoration Failure

Intervention / Treatment
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* Device: Filtek One
* Device: Filtek Z250


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In a split-mouth design, each participant will receive 2 matched restorations, one of each material.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filtek One<br>Bulk fill composite material used for posterior tooth fillings. | Device: Filtek One<br>* Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.<br>* Other names: 3M™ Filtek™ One Bulk Fill Restorative;|
| Active Comparator: Filtek Z250<br>Composite material used for incremental filling of posterior teeth. | Device: Filtek Z250<br>* Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.<br>* Other names: 3M™ Filtek™ Z250 Universal Restorative;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with restoration failure of either material | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance score for each restoration | Quality rating for each restoration/material based on the FDI clinical performance scores (1-5) for the three categories esthetic, functional and biological performance. | 2 years | 
| Confirmation of material safety | 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). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Composite resin