Clinical Performance of Posterior Composite Tooth Fillings in Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03175627|
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment|
|Dental Caries Dental Restoration Failure||Device: Filtek One Device: Filtek Z250|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
|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|
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
- 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.
- 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.
- 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).
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
|Contact: Kelly D Treas, RDHfirstname.lastname@example.org|
|Contact: Adriana C Wilson, DDS, MsD||(504) email@example.com|
|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 firstname.lastname@example.org|
|Contact: Adriana C Wilson, DDS, MsD 504-941-8283 email@example.com|
|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|
|Study Director:||Mathilde C Peters, DMD, PhD||LSUHSC School of Dentistry|