ClinicalTrials.gg
Active, not recruitingNCT04825379Updated Dec 9, 2025

Clinical Evaluation of a Bioactive Material

An interventional study of bioactive composite and posterior 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 2025-12-09.

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

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tooth Disease

Browse trials for

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 31 is below the median of 49 across 63 interventional studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

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.

04

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
05

Study design

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

Study arms

  • Experimental
    bioactive composite

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

    Device: bioactive composite

  • Experimental
    posterior resin composite

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

    Device: posterior composite

Interventions

  • Devicebioactive composite

    Cention N

  • Deviceposterior composite

    G-ænial Posterior

06

What researchers measure

Primary outcomes

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

    Two year results according to FDI criteria

    Time frame: two years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2021 to primary completion in Sep 2021, 3 months.

Of 32 non-industry interventional studies with no phase under Tooth Diseases, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 3 months is below that.

Counting every sponsor, half of 39 studies reached it within 12 months; a quarter within 4 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2021
First posted
Apr 1, 2021
StartActual
Jun 1, 2021
Primary completionActual
Sep 1, 2021
CompletionEst.
Sep 1, 2026
Last update
Dec 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04825379
Responsible party
Dr. Fatma Dilşad Öz (Assoc. Prof. Dr., Hacettepe University) — Principal investigator
First posted
Apr 1, 2021
Start date
Jun 1, 2021
Primary completion
Sep 1, 2021
Completion
Sep 1, 2026 (estimated)
Last update
Dec 9, 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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion