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CompletedNCT03708510Updated Apr 17, 2024

Clinical Evaluation of Two Low-shrinkage Composites

An interventional study of Restorative materials- Filtek Silorane and Restorative materials-Kalore in Tooth Diseases, sponsored by Hacettepe University. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.

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

From the registry’s dates

  • Registered 7 years 5 months after the study started (first participant enrolled May 2011, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Patients with 4 occlusal lesions in molar teeth will be included. Occlusal cavities will be prepared either by Er,Cr:YSGG laser (LS) or conventional diamond bur (BR). Cavities will be restored with Filtek Silorane (3M-ESPE) (SR) and with Kalore (GC) (KR) according to the manufacturers' instructions. All restorative procedures will be performed by one operator and the restorations will be examined by two evaluators according to the FDI (World Dental Federation) criteria at baseline and at 6-month, 1-, 2-,3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-year. Patients' satisfaction about the preparation methods will be evaluated with a survey. Pearson Chi-Square test will be used for statistical analyze(p=0.05).

02

Conditions studied

  • Tooth Diseases

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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 18 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 60 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

  1. age range will be 18 to 60
  2. patients should have at least 4 occlusal caries lesions require restoration
  3. healty periodontal status
  4. a good likelihood of recall availability

Exclusion criteria

Exclusion Criteria:

  1. poor gingival health
  2. adverse medical history
  3. potential behavioral problems
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Filtek Silorane-Er,Cr:YSGG Laser

    Device: Restorative materials- Filtek Silorane · Device: Preparation-Er,Cr:YSGG Laser

  • Experimental
    Filtek Silorane- Diamond Bur

    Device: Restorative materials- Filtek Silorane · Device: Preparation- Diamond Bur

  • Experimental
    Kalore- Er,Cr:YSGG Laser

    Device: Restorative materials-Kalore · Device: Preparation-Er,Cr:YSGG Laser

  • Experimental
    Kalore- Diamond Bur

    Device: Restorative materials-Kalore · Device: Preparation- Diamond Bur

Interventions

  • DeviceRestorative materials- Filtek Silorane

    Filtek Silorane

  • DeviceRestorative materials-Kalore

    Kalore

  • DevicePreparation-Er,Cr:YSGG Laser

    Er,Cr:YSGG Laser

  • DevicePreparation- Diamond Bur

    Bur

06

What researchers measure

Primary outcomes

  1. Clinical performance of different low-shrinkage composites and preparations

    Evaluations according to FDI criteria

    Time frame: 10 years

07

Study locations

No study locations are listed for this record.

08

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 May 2011 to primary completion in Sep 2011, 4 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 4 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
Oct 14, 2018
First posted
Oct 17, 2018
StartActual
May 1, 2011
Primary completionActual
Sep 1, 2011
CompletionActual
Sep 1, 2018
Last update
Apr 17, 2024
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 Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03708510
Responsible party
Dr. Fatma Dilşad Öz (Doctor, DDS, PhD, Hacettepe University) — Principal investigator
First posted
Oct 17, 2018
Start date
May 1, 2011
Primary completion
Sep 1, 2011
Completion
Sep 1, 2018
Last update
Apr 17, 2024

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 completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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