Clinical Performance of Posterior Composite Tooth Fillings in Adults

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

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

Study Overview

• Status: Completed
• Conditions: Dental Caries; Dental Restoration Failure
• Intervention / Treatment: Device: Filtek One; Device: Filtek Z250

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Lousiana State University Health Science Center, School of DentistrySchool of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Filtek One; Bulk fill composite material used for posterior tooth fillings.	Device: Filtek One; 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
Active Comparator: Filtek Z250; Composite material used for incremental filling of posterior teeth.	Device: Filtek Z250; Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.; Other Names: 3M™ Filtek™ Z250 Universal Restorative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	2 years

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborators: 3M
• Investigators: Study Director: Mathilde C Peters, DMD, PhD, LSUHSC School of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Dental caries; Proximal surfaces; Posterior teeth; Carious lesions; Tooth diseases; Dental restorations; Composite resin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 11-050008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes