Dental Caries
Conditions
Keywords
dental composite resin, dental caries
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.
Interventions
DEVICEdental 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
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
split-mouth
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical acceptability of restorations according to FDI criteria | 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
| Measure | Time frame | Description |
|---|---|---|
| Color difference (ΔE00) using the CIEDE2000 system | 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. |
Contacts
Primary Contactsafa tuncer, Phd DDs
Outcome results
None listed