Clinical Performance of Posterior Composite Tooth Fillings in Adults

Not Applicable

Completed

• Conditions: Dental Restoration Failure; Dental Caries
• Interventions: Device: Filtek One; Device: Filtek Z250

• Registration Number: NCT03175627
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-05-10
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Filtek One	Filtek One	Bulk fill composite material used for posterior tooth fillings.
Filtek Z250	Filtek Z250	Composite material used for incremental filling of posterior teeth.

Primary Outcome Measures

Name	Time	Method
Number of participants with restoration failure of either material	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 Outcome Measures

Name	Time	Method
Clinical performance score for each restoration	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.
Confirmation of material safety	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).

Trial Locations

Locations (1)

Lousiana State University Health Science Center, School of DentistrySchool of Dentistry; 🇺🇸 New Orleans, Louisiana, United States