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Clinical Evaluation of a Bioactive Material

Primary Purpose

Tooth Disease

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
bioactive composite
posterior composite
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

bioactive composite

posterior resin composite

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical performances of different restorative systems according to FDI criteria
Two year results according to FDI criteria

Secondary Outcome Measures

Full Information

First Posted
March 28, 2021
Last Updated
October 2, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04825379
Brief Title
Clinical Evaluation of a Bioactive Material
Official Title
Clinical Evaluation of a Bioactive Material
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bioactive composite
Arm Type
Experimental
Arm Description
Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)
Arm Title
posterior resin composite
Arm Type
Experimental
Arm Description
G-ænial Posterior (GC, Tokyo, Japan) (GP)
Intervention Type
Device
Intervention Name(s)
bioactive composite
Intervention Description
Cention N
Intervention Type
Device
Intervention Name(s)
posterior composite
Intervention Description
G-ænial Posterior
Primary Outcome Measure Information:
Title
Clinical performances of different restorative systems according to FDI criteria
Description
Two year results according to FDI criteria
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Evaluation of a Bioactive Material

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