NCT04324008

Brief Summary

The aim of this study is to evaluate a self-adhesive flowable resin composite, a flowable resin composite with high viscosity and a conventional flowable resin composite in combination with a universal adhesive using two different application modes. All patients will receive at least 4 occlusal restorations. Cavities will be divided into four groups according to restorative systems used: Constic (a self-adhering flowable composite), G-ænial Universal Flo (a highly filled flowable composite), Tetric N-Flow (self-etch) (a conventional flowable composite), Tetrin N-Flow (etch\&rinse).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress95%
Nov 2017Nov 2026

Study Start

First participant enrolled

November 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

March 25, 2020

Last Update Submit

December 2, 2025

Conditions

Keywords

flowable resin compositeocclusal

Outcome Measures

Primary Outcomes (1)

  • Clinical performances of different flowable resin composite

    Two year results according to USPHS criteria

    two years

Study Arms (4)

Constic

EXPERIMENTAL

Constic (DMG, Hamburg, Germany)

Device: Constic

G-ænial Universal Flo

EXPERIMENTAL

G-ænial Universal Flo (GC Corporation, Tokyo, Japan) in combination with G-Premio Bond (self-etch mode)

Device: G-ænial Universal Flo

Tetric N-Flow (self-etch)

EXPERIMENTAL

Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (self-etch mode)

Device: Tetric N-Flow (self-etch)

Tetric N-Flow (etch&rinse)

EXPERIMENTAL

Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (etch\&rinse mode)

Device: Tetric N-Flow (etch&rinse)

Interventions

ConsticDEVICE

Flowable resin composite

Constic

Flowable resin composite

G-ænial Universal Flo

Tetric N-Flow (Tetric N-Bond Universal, self-etch mode)

Tetric N-Flow (self-etch)

Tetric N-Flow (Tetric N-Bond Universal, etch\&rinse mode)

Tetric N-Flow (etch&rinse)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth DiseasesBites and Stings

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

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
Assistant Professor

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

November 1, 2017

Primary Completion

January 1, 2018

Study Completion (Estimated)

November 1, 2026

Last Updated

December 3, 2025

Record last verified: 2025-12

Locations