Clinical Performance of Posterior Composite Tooth Fillings in Adults

NCT ID: NCT03175627

Last Updated: 2021-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-10

Study Completion Date

2021-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dental Caries Dental Restoration Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In a split-mouth design, each participant will receive 2 matched restorations, one of each material.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blind (Subject, Investigator, Outcomes Assessor)

Study Groups

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Filtek One

Bulk fill composite material used for posterior tooth fillings.

Group Type ACTIVE_COMPARATOR

Filtek One

Intervention Type DEVICE

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

Filtek Z250

Composite material used for incremental filling of posterior teeth.

Group Type ACTIVE_COMPARATOR

Filtek Z250

Intervention Type DEVICE

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

Interventions

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Filtek One

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

Intervention Type DEVICE

Filtek Z250

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

Intervention Type DEVICE

Other Intervention Names

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3M™ Filtek™ One Bulk Fill Restorative 3M™ Filtek™ Z250 Universal Restorative

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role lead

Responsible Party

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Adriana Cordero Wilson

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mathilde C Peters, DMD, PhD

Role: STUDY_DIRECTOR

LSUHSC School of Dentistry

Locations

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

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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11-050008

Identifier Type: -

Identifier Source: org_study_id

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