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Clinical Evaluation of a Bioactive Material

Clinical Evaluation of a Bioactive Material

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04825379
Enrollment
31
Registered
2021-04-01
Start date
2021-06-01
Completion date
2026-09-01
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Disease

Brief summary

The clinical performance of a bioactive composite and a posterior resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 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 two groups: a bioactive composite \[Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)\] and a posterior resin composite \[G-ænial Posterior (GC, Tokyo, Japan) (GP)\] 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

Cention N

DEVICEposterior composite

G-ænial Posterior

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* age range will be 18 to 65 * patients should have at least 2 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical performances of different restorative systems according to FDI criteriatwo yearsTwo year results according to FDI criteria

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026