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Clinical Evaluation of a Bioactive Material

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04825379
Recruitment Status : Active, not recruiting
First Posted : April 1, 2021
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Fatma Dilşad Öz, Hacettepe University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tooth Disease Device: bioactive composite Device: posterior composite Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a Bioactive Material
Actual Study Start Date : June 1, 2021
Actual Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Disorders

Arms and Interventions
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Arm Intervention/treatment
Experimental: bioactive composite
Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)
 Device: bioactive composite
Cention N
Experimental: posterior resin composite
G-ænial Posterior (GC, Tokyo, Japan) (GP)
 Device: posterior composite
G-ænial Posterior


Outcome Measures
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Primary Outcome Measures :
  1. Clinical performances of different restorative systems according to FDI criteria [ Time Frame: two years ]
    Two year results according to FDI criteria


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04825379


Locations
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Turkey
Hacettepe University
Ankara, Turkey
Sponsors and Collaborators
Hacettepe University
More Information
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Responsible Party: Dr. Fatma Dilşad Öz, Assoc. Prof. Dr., Hacettepe University
ClinicalTrials.gov Identifier: NCT04825379    
Other Study ID Numbers: bioactive-composite
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Diseases
Stomatognathic Diseases