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

NCT07289022 | Not Yet Recruiting

• 1 other identifier: 2025-038
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

dental composite resin; dental caries

Outcome Measures

Primary Outcomes (1)

• Clinical acceptability of restorations according to FDI criteria

  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.

  6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Secondary Outcomes (1)

• Color difference (ΔE00) using the CIEDE2000 system

  1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Study Arms (2)

Three posterior caries lesions will be separated into three monochromatic dental composite groups

OTHER

Treatment of posterior caries lesions. Three of the carious lesions in the posterior four caries teeth will be separated into three groups according to material strategies described below: 1-monochromatic bulk without pigment flowable composite Omnichroma Flow Bulk (tokuyama dental) , 2-monochromatic bulk flowable composite Charisma Bulk Flow One (Kulzer), 3- monochromatic flowable composite Clearfil Majesty™ ES flow-low (Kuraray),

Device: dental composite

One posterior caries lesion will be separated into one polychromatic dental flowable composite

OTHER

Treatment of posterior caries lesion. One of the carious lesions in the posterior four caries teeth will be separated according to the material strategies used for Grandio SO flowable polychromatic dental composite (Voco) as a control group

Device: dental composite

Interventions

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

One posterior caries lesion will be separated into one polychromatic dental flowable composite; Three posterior caries lesions will be separated into three monochromatic dental composite groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

safa tuncer, Phd DDs

CONTACT

+905336342450; tuncers@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: split-mouth

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 17, 2025
• Study Start: January 5, 2026
• Primary Completion: May 5, 2026
• Study Completion (Estimated): April 5, 2031
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share