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

I

Istanbul University

Status

Not yet enrolling

Conditions

Dental Caries

Treatments

Device: dental composite

Study type

Interventional

Funder types

Other

Identifiers

NCT07289022
2025-038

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Three posterior caries lesions will be separated into three monochromatic dental composite groups
Other group
Description:
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),
Treatment:
Device: dental composite
One posterior caries lesion will be separated into one polychromatic dental flowable composite
Other group
Description:
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
Treatment:
Device: dental composite

Trial contacts and locations

0

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Central trial contact

safa tuncer, Phd DDs

Data sourced from clinicaltrials.gov

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