NCT03556553

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2011

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

May 24, 2018

Last Update Submit

September 13, 2021

Conditions

Tooth Diseases

Keywords

composite resinocclusal caries

Outcome Measures

Primary Outcomes (1)

  • Clinical performances of flowable composite resins

    Five year results according to FDIcriteria

    Five years

Study Arms (2)

Vertise Flow

EXPERIMENTAL

Superficial Class I cavities restored with Vertise Flow

Device: Vertise Flow

LuxaFlow

EXPERIMENTAL

Superficial Class I cavities restored with LuxaFlow

Device: LuxaFlowDevice: Teco Adhesive

Interventions

Vertise FlowDEVICE

Composite resin

Also known as: Self-adhering flowable composite
Vertise Flow
LuxaFlowDEVICE

Composite resin

Also known as: Flowable composite with Teco adhesive system
LuxaFlow
Teco AdhesiveDEVICE

Adhesive system

LuxaFlow

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, DDS

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 14, 2018

Study Start

March 30, 2011

Primary Completion

June 30, 2011

Study Completion

June 30, 2016

Last Updated

September 14, 2021

Record last verified: 2021-09