Clinical Performance of Posterior Composite Tooth Fillings in Adults

Louisiana State University Health Sciences Center in New Orleans55 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dental Caries Dental Restoration Failure

Interventions

Filtek OneDEVICE

Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.

Filtek Z250DEVICE

Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lousiana State University Health Science Center, School of DentistrySchool of Dentistry

New Orleans, Louisiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 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).

Time frame: 2 years

Data from ClinicalTrials.gov

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