NCT04565860

Brief Summary

Composite resins have been widely used in the last years to restore teeth due to increases in patients' esthetic expectations. Therefore optical and mechanical properties of composite resins were being developed day by day. Although there have been many in vitro studies about bulk-fill composite in the literature, the number of clinical trials is insufficient. Therefore, the aim of this study was to evaluate the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental techniques) in Class II carious lesions using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 15, 2020

Last Update Submit

September 24, 2020

Conditions

Dental Composite

Keywords

Bulk-fill compositeIncremental techniqueComposite resinFDIUSBHS

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.

    FDI; The World Dental Federation. USPHS; The United States Public Health Service. The 2-year results of the restorations were evaluated with the FDI and USPHS criteria. Two calibrated observers who were blinded to the objective of this study performed the evaluations.

    Two-year

  • Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.

    FDI; The World Dental Federation. USPHS; The United States Public Health Service. The 4-year results of the restorations were evaluated with the FDI and USPHS criteria. Two calibrated observers who were blinded to the objective of this study performed the evaluations.

    Four-year

Study Arms (4)

X-tra fil (bulk-filling) (X-traB)

ACTIVE COMPARATOR

X-tra fil composite placed as bulk-filling

Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)

X-tra fil (incremental) (X-traI)

ACTIVE COMPARATOR

X-tra fil composite placed as incremental

Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)

Filtek Bulk (bulk-filling) (FBB)

ACTIVE COMPARATOR

Filtek Bulk composite placed as bulk-filling

Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)

Filtek Bulk (incremental) (FBI)

ACTIVE COMPARATOR

Filtek Bulk composite placed as incremental

Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)

Interventions

Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)OTHER

Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick. In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).

Also known as: X-tra fil (Voco) bulk-fill composite resin. Filtek Bulk (3M ESPE) bulk-fill composite resin
Filtek Bulk (bulk-filling) (FBB)Filtek Bulk (incremental) (FBI)X-tra fil (bulk-filling) (X-traB)X-tra fil (incremental) (X-traI)

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least 4 Class-II caries lesions
  • Good health
  • Acceptable level of oral hygiene

You may not qualify if:

  • Did not have four caries lesions at least
  • Did not have Class-II caries lesions
  • Deep caries reaching the pulp
  • The patients are not 18-20 years old
  • Bruxism
  • Periodontal disease
  • Refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuh Naci Yazgan University

Kayseri, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant, Investigator, Outcomes Assessor)
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof Nurdan Çakır

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 25, 2020

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

September 25, 2020

Record last verified: 2020-09

Locations

TU(1)