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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

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

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
04

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

05

What researchers measure

Primary outcomes

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

    Evaluations according to FDI criteria

    Time frame: 10 years

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03708510
Lead sponsor
Hacettepe University
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 ↗

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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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