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Active, not recruitingNCT04685967Updated Dec 3, 2025

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

An interventional study of Glass ionomer and Bulk-fill composite in Tooth Disease, sponsored by Hacettepe University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Tooth Disease

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03

In context

Tooth Diseases

79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.

This study's enrollment of 23 is below the median of 49 across 63 interventional studies indexed under Tooth Diseases.

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Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Glass-ionomer

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

    Device: Glass ionomer

  • Experimental
    Bulk-Fill

    SonicFill2, Orange, CA, USA (SBF)

    Device: Bulk-fill composite

Interventions

  • DeviceGlass ionomer

    Equia Forte HT, GC, Tokyo, Japan

  • DeviceBulk-fill composite

    SonicFill2, Orange, CA, USA

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What researchers measure

Primary outcomes

  1. Clinical performances of different restorative systems according to USPHS criteria

    Two year results according to USPHS criteria

    Time frame: two years

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04685967
Responsible party
Dr. Fatma Dilşad Öz (Assoc. Prof., Hacettepe University) — Principal investigator
First posted
Dec 28, 2020
Start date
Mar 15, 2021
Primary completion
Aug 15, 2021
Completion
Aug 15, 2026 (estimated)
Last update
Dec 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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