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

NCT07289022 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Dental Caries

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 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

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2026-05-05
Completion
2031-04-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07289022 on ClinicalTrials.gov