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Not yet recruiting NCT07524842

Clinical Performance of Three Different Restorative Materials

No phase Interventional Tooth Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bioactive composite, nanohybrid resin composite, bulk-fill resin composite.
Who it may be relevant to
Registry conditions: Tooth Disease. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Performance of Three Different Restorative Materials-Nanohybrid, Bulk-fill, and Alkasite-based

Overview

The clinical performance of a bioactive composite (alkasite-based), a nanohybrid resin composite and a bulk-fill resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 3 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into three groups: a bioactive composite \[Cention Forte Ivoclar Vivadent, Schaan, Liechtenstein\], a nanohybrid resin composite \[Tetric N-Ceram2 (Ivoclar Vivadent, Schaan, Liechtenstein)\] and a bulk-fill resin composite \[Tetric N-PowerFill2 (Ivoclar Vivadent, Schaan, Liechtenstein)\], All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

Interventions

  • Device bioactive composite
    bioactive composite restoration
  • Device nanohybrid resin composite
    nanohybrid resin composite restoration
  • Device bulk-fill resin composite
    bulk-fill resin composite restoration

Primary outcome measures

  • Clinical performances of different restorative systems according to FDI criteria [Time frame: two years]

Eligibility criteria

Inclusion criteria

  • age range will be 18 to 65
  • patients should have at least 3 approximal caries lesions require restoration
  • healthy periodontal status
  • a good likelihood of recall availability

Exclusion criteria

  • poor gingival health
  • adverse medical history
  • potential behavioral problems

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07524842 · bioactive-alkasite

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗