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Completed

NCT Number: NCT03175627

Clinical Performance of Posterior Composite Tooth Fillings in Adults

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

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Key information

Conditions

Dental Caries Dental Restoration Failure Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New Orleans, Louisiana, 70119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Filtek One

Device

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

Other names: 3M™ Filtek™ One Bulk Fill Restorative

Filtek Z250

Device

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

Other names: 3M™ Filtek™ Z250 Universal Restorative

Primary outcomes

  1. Number of participants with restoration failure of either material

    Time frame: 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 outcomes

  1. Clinical performance score for each restoration

    Time frame: 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.

  2. Confirmation of material safety

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2017
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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