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NCT Number: NCT07289022

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dental composite

Device

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 be used across arms per manufacturer's instructions (self etch).

Placement:

Control (polychromatic): Layered placement per manufacturer. Single-shade/flowable/bulk-fill arms: Incremental or bulk placement within 2-5 mm as recommended.

Light curing: Light-emitting diode (LED) light-curing units at 1200 mW/cm² for 20 s per increment; distance and angulation standardized.

Assessment and follow-up: Baseline, 6 months, and annually up to 5 years. Color measured with Vita Easyshade

Primary outcomes

  1. Clinical acceptability of restorations according to FDI criteria

    Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    Restorations will be evaluated by a blinded assessor using the World Dental Federation (FDI) criteria across functional, esthetic, and biological domains. Clinical acceptability is defined as FDI scores 1-3. The primary analysis will report the proportion of clinically acceptable restorations and the trajectory of scores over time.

Secondary outcomes

  1. Color difference (ΔE00) using the CIEDE2000 system

    Time frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    objective color measurements will be obtained with a spectrophotometer (Vita Easyshade Compact, VITA Zahnfabrik, Bad Säckingen, Germany). L*, a*, b* values will be recorded on the restoration and adjacent tooth surfaces at each follow-up. Color difference will be calculated using the CIEDE2000 formula (ΔE00). Clinical acceptability will be defined by a predefined threshold (e.g., ΔE00 ≤ 1.8), and both mean ΔE00 and the proportion of clinically acceptable cases will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

safa tuncer, Phd DDs

CONTACT

[email protected]

+905336342450

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2031
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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