Clinical Performance of Posterior Composite Tooth Fillings in Adults

Dental Caries Clinical Trial

Official title:

Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175627
• Other study ID #: 11-050008
• Status: Completed
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Restoration Failure

Intervention

Device:
• Filtek One
Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.
• Filtek Z250
Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.

Locations

Country	Name	City	State
United States	Lousiana State University Health Science Center, School of DentistrySchool of Dentistry	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years
Secondary	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).	2 years