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

NCT ID: NCT03556553

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tooth Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vertise Flow

Superficial Class I cavities restored with Vertise Flow

Group Type EXPERIMENTAL

Vertise Flow

Intervention Type DEVICE

Composite resin

LuxaFlow

Superficial Class I cavities restored with LuxaFlow

Group Type EXPERIMENTAL

LuxaFlow

Intervention Type DEVICE

Composite resin

Teco Adhesive

Intervention Type DEVICE

Adhesive system

Interventions

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Vertise Flow

Composite resin

Intervention Type DEVICE

LuxaFlow

Composite resin

Intervention Type DEVICE

Teco Adhesive

Adhesive system

Intervention Type DEVICE

Other Intervention Names

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Self-adhering flowable composite Flowable composite with Teco adhesive system

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fatma Dilşad Öz

PhD, DDS

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Vertise-Luxa Flow

Identifier Type: -

Identifier Source: org_study_id

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