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

NCT ID: NCT07289022

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2031-04-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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),

Group Type: OTHER

dental composite

Intervention Type: 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

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

Group Type: OTHER

dental composite

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Safa Tuncer

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

safa tuncer, Phd DDs

Role: CONTACT

Phone: +905336342450

Email: tuncers@istanbul.edu.tr

References

Weick A. Issues in overturning a medical model of social work practice. Soc Work. 1983 Nov-Dec;28(6):467-71. doi: 10.1093/sw/28.6.467. No abstract available.

Reference Type: BACKGROUND

PMID: 10264483 (View on PubMed)

Other Identifiers

2025-038

Identifier Type: -

Identifier Source: org_study_id