Clinical Evaluation of Flowable Monochromatic and Polychromatic Composite Resins in Posterior Restorations

Official title

Evaluation of the Color Matching Ability and Clinical Success of Flowable Monochromatic and Polychromatic Composite Resins in Posterior Restorations

Overview

This clinical study aims to investigate whether a single flowable composite resin system can achieve adequate color matching in posterior restorations and to compare it with a polychromatic composite system, which will serve as a control group. Clinical success will also be assessed using data obtained from the initial, six month, one-year, two-year, three-year, four-year, and five-year recall checks of the four different composite resin systems used in the study over a five-year period. L, a, and b parameters will be determined using the Vita Easyshade Compact (VITA Zahnfabrik, Bad Sackingen, Germany) Spectrophotometer device used in the study at the initial, half-year, one-year, two-year, three-year, four-year, and five-year intervals. Based on the obtained data, intraoral color changes will be determined using the CIEDE2000 color system. Each patient will be scanned with an intraoral scanner at each session. The hypothesis tested was that color matching and long-term clinical follow-up would be successful for all composite materials used in the study.

Interventions

• Device dental composite
  Overview: Four composite resin systems will be evaluated in posterior Class II restorations for color matching ability and clinical performance over 5 years. A polychromatic composite serves as the control; three single-shade/flowable or bulk-fill composites constitute the intervention arms. Isolation and preparation: All restorations will be performed under rubber dam using standardized cavity preparation and finishing/polishing protocols. Adhesive and etching: A single adhesive approach will

Primary outcome measures

• Clinical acceptability of restorations according to FDI criteria [Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]

Secondary outcome measures (1)

• Color difference (ΔE00) using the CIEDE2000 system [Time frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]

Eligibility criteria

Inclusion criteria

• Participants must be over 18 years of age and have no systemic disease.
• Participants must have acceptable oral hygiene and at least 20 teeth in occlusion.
• Participants must have at least four Class I-II carious lesions requiring treatment.
• Lesions must involve both enamel and dentin, and the involved teeth must be vital and non-mobile.
• All participants must read and sign an informed consent form prior to enrollment.

Exclusion criteria

• Presence of any general health problem (systemic disease).
• Periodontal disease or poor oral hygiene.
• Tooth mobility or non-vital teeth in the target teeth.
• Bruxism or uncontrolled parafunction

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12. PMID 36504246

Identifiers

NCT: NCT07289022 · 2025-038

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗