Clinical Evaluation of Two Low-shrinkage Composites

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

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).

Study Overview

• Status: Completed
• Conditions: Tooth Diseases
• Intervention / Treatment: Device: Restorative materials- Filtek Silorane; Device: Preparation-Er,Cr:YSGG Laser; Device: Preparation- Diamond Bur; Device: Restorative materials-Kalore

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Filtek Silorane-Er,Cr:YSGG Laser	Device: Restorative materials- Filtek Silorane; Filtek Silorane; Device: Preparation-Er,Cr:YSGG Laser; Er,Cr:YSGG Laser
Experimental: Filtek Silorane- Diamond Bur	Device: Restorative materials- Filtek Silorane; Filtek Silorane; Device: Preparation- Diamond Bur; Bur
Experimental: Kalore- Er,Cr:YSGG Laser	Device: Preparation-Er,Cr:YSGG Laser; Er,Cr:YSGG Laser; Device: Restorative materials-Kalore; Kalore
Experimental: Kalore- Diamond Bur	Device: Preparation- Diamond Bur; Bur; Device: Restorative materials-Kalore; Kalore

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance of different low-shrinkage composites and preparations	Evaluations according to FDI criteria	10 years

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: October 14, 2018
• First Submitted That Met QC Criteria: October 14, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases
• Other Study ID Numbers: Kalore-Silorane, Laser-Bur

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No