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Clinical Performance of Posterior Composite Tooth Fillings in Adults

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ClinicalTrials.gov Identifier: NCT03175627
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
3M Health Care
Information provided by (Responsible Party):
Adriana Cordero Wilson, 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.

Condition or disease Intervention/treatment Phase
Dental Caries Dental Restoration Failure Device: Filtek One Device: Filtek Z250 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In a split-mouth design, each participant will receive 2 matched restorations, one of each material.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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 Name: 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 Name: 3M™ Filtek™ Z250 Universal Restorative




Primary Outcome Measures :
  1. Number of participants with restoration failure of either material [ Time Frame: 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 :
  1. Clinical performance score for each restoration [ Time Frame: 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.

  2. Confirmation of material safety [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175627


Contacts
Contact: Kelly D Treas, RDH 985-817-9599 kdufr2@lsuhsc.edu
Contact: Adriana C Wilson, DDS, MsD (504) 941-8283 acorde@lsuhsc.edu

Locations
United States, Louisiana
Lousiana State University Health Science Center, School of DentistrySchool of Dentistry Recruiting
New Orleans, Louisiana, United States, 70119
Contact: Kelly D Treas, RDH    985-817-9599    kdufr2@lsuhsc.edu   
Contact: Adriana C Wilson, DDS, MsD    504-941-8283    acorde@lsuhsc.edu   
Principal Investigator: Adriana C Wilson, DDS, PhD         
Principal Investigator: Mathilde C Peters, DMD, PhD         
Sub-Investigator: William R Yeadon, DDS         
Sub-Investigator: Jonathan X Esquivel, DDS         
Sub-Investigator: Faye Mascarenhas, BDS, MS         
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
3M Health Care
Investigators
Study Director: Mathilde C Peters, DMD, PhD LSUHSC School of Dentistry

Responsible Party: Adriana Cordero Wilson, Clinical Assistant Professor, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT03175627     History of Changes
Other Study ID Numbers: 11-050008
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Adriana Cordero Wilson, Louisiana State University Health Sciences Center in New Orleans:
Dental caries
Proximal surfaces
Posterior teeth
Carious lesions
Tooth diseases
Dental restorations
Composite resin

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases