Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities

Tooth Diseases Clinical Trial

Official title:

Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556553
• Other study ID #: Vertise-Luxa Flow
• Status: Completed
• Phase: N/A
• Start date: March 30, 2011
• Est. completion date: June 30, 2016

Study information

• Verified date: September 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate long-term clinical performance of a self-adhering flowable resin composite in comparison with a conventional flowable resin composite used with an etch&rinse adhesive system in minimally invasive class I cavities. Twenty-five patients will receive at least one pair of class I restorations. After class I cavities were prepared they were restored either with a self-adhering flowable resin composite (VertiseFlow/Kerr-VR) or with a flowable resin composite (Luxaflow/DMG-LX) in combination with an etch&rinse adhesive (Teco/DMG) [according to the manufacturers' instructions. Restorations will be evaluated at baseline and yearly according to FDI criteria by two evaluaters. Statistical analysis will be carried out with Pearson Chi-Square test and Cochran Q-test followed by Mc Nemar's.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• having no medical or behavioral problems preventing then from attending review visits, absence of previously placed restorations,having antagonist teeth

Exclusion Criteria:

• poor gingival health,uncontrolled, rampant caries,bruxism,removable partial dentures, xerostomia

Related Conditions & MeSH terms

• Tooth Diseases

Intervention

Device:
• Vertise Flow
Composite resin
• LuxaFlow
Composite resin
• Teco Adhesive
Adhesive system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performances of flowable composite resins	Five year results according to FDIcriteria	Five years