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Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin

Primary Purpose

Tooth Disease

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Glass ionomer
Bulk-fill 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

Glass-ionomer

Bulk-Fill

Arm Description

Equia Forte HT, GC, Tokyo, Japan (EHT)

SonicFill2, Orange, CA, USA (SBF)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 22, 2020
Last Updated
December 20, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04685967
Brief Title
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin
Official Title
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
May 1, 2025 (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 restorative glass ionomer and bulk-fill 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 restorative glass ionomer [Equia Forte HT, GC, Tokyo, Japan (EHT)] and bulk-fill composite resin [SonicFill2, Orange, CA, USA (SBF)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) 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
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glass-ionomer
Arm Type
Experimental
Arm Description
Equia Forte HT, GC, Tokyo, Japan (EHT)
Arm Title
Bulk-Fill
Arm Type
Experimental
Arm Description
SonicFill2, Orange, CA, USA (SBF)
Intervention Type
Device
Intervention Name(s)
Glass ionomer
Intervention Description
Equia Forte HT, GC, Tokyo, Japan
Intervention Type
Device
Intervention Name(s)
Bulk-fill composite
Intervention Description
SonicFill2, Orange, CA, USA
Primary Outcome Measure Information:
Title
Clinical performances of different restorative systems according to USPHS criteria
Description
Two year results according to USPHS 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 Restorative Glass Ionomer and a Bulk-fill Composite Resin

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