Clinical Performance of Posterior Composite Tooth Fillings in Adults

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Louisiana State University

Status

Completed

Conditions

Dental Caries
Dental Restoration Failure

Treatments

Device: Filtek Z250
Device: Filtek One

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03175627
11-050008

Details and patient eligibility

About

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

Full 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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

55 participants in 2 patient groups

Filtek One
Active Comparator group
Description:
Bulk fill composite material used for posterior tooth fillings.
Treatment:
Device: Filtek One
Filtek Z250
Active Comparator group
Description:
Composite material used for incremental filling of posterior teeth.
Treatment:
Device: Filtek Z250

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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