Clinical Evaluation of a Bioactive Material

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Tooth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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bioactive composite

Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)

Group Type EXPERIMENTAL

bioactive composite

Intervention Type DEVICE

Cention N

posterior resin composite

G-ænial Posterior (GC, Tokyo, Japan) (GP)

Group Type EXPERIMENTAL

posterior composite

Intervention Type DEVICE

G-ænial Posterior

Interventions

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bioactive composite

Cention N

Intervention Type DEVICE

posterior composite

G-ænial Posterior

Intervention Type DEVICE

Eligibility Criteria

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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