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Clinical Evaluation of Bulk-fill Composite Resins in Class II Restorations

Erciyes University Clinical Research Ethics Committee

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04565860
Enrollment
158
Registered
2020-09-25
Start date
2016-01-01
Completion date
2018-03-01
Last updated
2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Composite

Keywords

Bulk-fill composite, Incremental technique, Composite resin, FDI, USBHS

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).

Detailed description

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. Composite resin restorations have the main advantages such as conservative cavity preparation, preserving healthy dental tissue, and strengthening the remaining tooth structure. Furthermore, according to clinical studies, high clinical performance and good longevity have been reported. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique. The incremental technique provides sufficient light penetration and monomer conversion. However, there are many disadvantages to the incremental technique. For instance, bonding failure, blood, or saliva contamination of between layers, the difficulty of application in limited access in small cavities, and to be time-consuming. Because of these, manufacturers have presented a bulk-fill composites, which could be polymerized in a single layer up to 4-5 mm thick to the market. Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick. Bulk-fill composites that were introduced in recent years can be manipulated faster and more convenient in the cavity compared to conventional hybrid composites. In addition, these materials present good mechanical properties such as marginal adaptation, sealing properties, fracture strength, wear-resistance, and long-term clinical success. Clinical studies are required to clearly describe the clinical behavior of the materials. 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)

Interventions

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

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).

Sponsors

TC Erciyes University
CollaboratorOTHER
Nuh Naci Yazgan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Triple (Participant, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 22 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
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.Two-yearFDI; 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026