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Clinical Performance of Posterior Composite Tooth Fillings in Adults

Primary Purpose

Dental Caries, Dental Restoration Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Filtek One
Filtek Z250
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Composite resin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Filtek One

Filtek Z250

Arm Description

Bulk fill composite material used for posterior tooth fillings.

Composite material used for incremental filling of posterior teeth.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
May 31, 2017
Last Updated
June 25, 2021
Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
3M
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1. Study Identification

Unique Protocol Identification Number
NCT03175627
Brief Title
Clinical Performance of Posterior Composite Tooth Fillings in Adults
Official Title
Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
3M

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Dental Restoration Failure
Keywords
Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Composite resin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In a split-mouth design, each participant will receive 2 matched restorations, one of each material.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind (Subject, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filtek One
Arm Type
Active Comparator
Arm Description
Bulk fill composite material used for posterior tooth fillings.
Arm Title
Filtek Z250
Arm Type
Active Comparator
Arm Description
Composite material used for incremental filling of posterior teeth.
Intervention Type
Device
Intervention Name(s)
Filtek One
Other Intervention Name(s)
3M™ Filtek™ One Bulk Fill Restorative
Intervention Description
Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.
Intervention Type
Device
Intervention Name(s)
Filtek Z250
Other Intervention Name(s)
3M™ Filtek™ Z250 Universal Restorative
Intervention Description
Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.
Primary Outcome Measure Information:
Title
Number of participants with restoration failure of either material
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Clinical performance score for each restoration
Description
Quality rating for each restoration/material based on the FDI clinical performance scores (1-5) for the three categories esthetic, functional and biological performance.
Time Frame
2 years
Title
Confirmation of material safety
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilde C Peters, DMD, PhD
Organizational Affiliation
LSUHSC School of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Lousiana State University Health Science Center, School of DentistrySchool of Dentistry
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Performance of Posterior Composite Tooth Fillings in Adults

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