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NCT03708510 Clinical Trial

Clinical Evaluation of Two Low-shrinkage Composites

Tooth Diseases Clinical Trial

Official title:
Clinical Evaluation of Two Low-shrinkage Composites After Different Preparation Techniques

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03708510
Other study ID # Kalore-Silorane, Laser-Bur
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2011
Est. completion date September 1, 2018

Study information
Verified date April 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date September 1, 2018
Est. primary completion date September 1, 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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: 1. poor gingival health 2. adverse medical history 3. potential behavioral problems

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Restorative materials- Filtek Silorane
Filtek Silorane
• Restorative materials-Kalore
Kalore
• Preparation-Er,Cr:YSGG Laser
Er,Cr:YSGG Laser
• Preparation- Diamond Bur
Bur

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hacettepe University

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical performance of different low-shrinkage composites and preparations Evaluations according to FDI criteria 10 years
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