Clinical Performance of Posterior Composite Tooth Fillings in Adults

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

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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