Clinical Performance of Three Different Restorative Materials
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Start
First participant enrolled
April 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2028
ExpectedMay 1, 2026
April 1, 2026
2 months
April 6, 2026
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical performances of different restorative systems according to FDI criteria
Two year results according to FDI criteria (scores 1-5, 1-very good, 5-poor/replace)
two years
Study Arms (3)
bioactive composite
EXPERIMENTALCention Forte Ivoclar Vivadent, Schaan, Liechtenstein
nanohybrid resin composite
EXPERIMENTALTetric N-Ceram2 (Ivoclar Vivadent, Schaan, Liechtenstein)
bulk-fill resin composite
EXPERIMENTALTetric N-PowerFill2 (Ivoclar Vivadent, Schaan, Liechtenstein)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- poor gingival health
- adverse medical history
- potential behavioral problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
April 6, 2026
First Posted
April 13, 2026
Study Start
April 28, 2026
Primary Completion
June 28, 2026
Study Completion (Estimated)
June 28, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share