Clinical Performance of Posterior Composite Tooth Fillings in Adults

NCT03175627 | Completed FDA Device

• 1 other identifier: 11-050008
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Caries; Dental Restoration Failure

Keywords

Dental caries; Proximal surfaces; Posterior teeth; Carious lesions; Tooth diseases; Dental restorations; Composite resin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical performance score for each restoration

  2 years

• Confirmation of material safety

  2 years

Study Arms (2)

Filtek One

ACTIVE COMPARATOR

Bulk fill composite material used for posterior tooth fillings.

Device: Filtek One

Filtek Z250

ACTIVE COMPARATOR

Composite material used for incremental filling of posterior teeth.

Device: Filtek Z250

Interventions

Filtek One DEVICE

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

Also known as: 3M™ Filtek™ One Bulk Fill Restorative

Filtek One

Filtek Z250 DEVICE

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

Also known as: 3M™ Filtek™ Z250 Universal Restorative

Filtek Z250

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• 3M: collaborator

Study Sites (1)

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

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

Dental Caries; Tooth Diseases

Condition Hierarchy (Ancestors)

Tooth Demineralization; Stomatognathic Diseases

Study Officials

• Mathilde C Peters, DMD, PhD

  LSUHSC School of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind (Subject, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: In a split-mouth design, each participant will receive 2 matched restorations, one of each material.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: May 10, 2017
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)