NCT04685967

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2021Aug 2026

First Submitted

Initial submission to the registry

December 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Expected
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 22, 2020

Last Update Submit

December 2, 2025

Conditions

Tooth Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical performances of different restorative systems according to USPHS criteria

    Two year results according to USPHS criteria

    two years

Study Arms (2)

Glass-ionomer

EXPERIMENTAL

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

Device: Glass ionomer

Bulk-Fill

EXPERIMENTAL

SonicFill2, Orange, CA, USA (SBF)

Device: Bulk-fill composite

Interventions

Glass ionomerDEVICE

Equia Forte HT, GC, Tokyo, Japan

Glass-ionomer
Bulk-fill compositeDEVICE

SonicFill2, Orange, CA, USA

Bulk-Fill

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 28, 2020

Study Start

March 15, 2021

Primary Completion

August 15, 2021

Study Completion (Estimated)

August 15, 2026

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)