Clinical Evaluation of a Bioactive Material

Not Applicable

Active, not recruiting

• Conditions: Tooth Disease
• Interventions: Device: bioactive composite; Device: posterior composite

• Registration Number: NCT04825379
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-28
• Study First Submitted QC: 2021-03-28
• Study First Posted: 2021-04-01
• Study Start: 2021-06-01
• Primary Completion: 2021-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bioactive composite	bioactive composite	Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)
posterior resin composite	posterior composite	G-ænial Posterior (GC, Tokyo, Japan) (GP)

Primary Outcome Measures

Name	Time	Method
Clinical performances of different restorative systems according to FDI criteria	two years	Two year results according to FDI criteria

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey