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Clinical Evaluation of a Bioactive Material

H

Hacettepe University

Status

Active, not recruiting

Conditions

Tooth Disease

Treatments

Device: posterior composite
Device: bioactive composite

Study type

Interventional

Funder types

Other

Identifiers

NCT04825379
bioactive-composite

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

31 participants in 2 patient groups

bioactive composite
Experimental group
Description:
Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)
Treatment:
Device: bioactive composite
posterior resin composite
Experimental group
Description:
G-ænial Posterior (GC, Tokyo, Japan) (GP)
Treatment:
Device: posterior composite

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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