An interventional study of Tetric EvoCeram Bulkfill and Surefil SDR Flowable bulkfill in Dental Caries, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 41 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-17.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the clinical performance of three different bulk-fill restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin composite and a fiber-reinforced resin in Class II restorations over a period of 24 months.
The objective of this study is to evaluate the 24-month clinical performance of three different bulk-fill restorative resin materials in Class II restorations. Forty patients with at least three approximal lesions in premolar and molar teeth will be participated in the study. A total of 120 Class II cavities will be restored using Tetric EvoCeram Bulk Fill (n=40), SureFil SDR flow + Ceram X mono (n=40), and everX Posterior + G-aenial Posterior (n=40) with their respective adhesives according to the manufacturers' instructions. All restorations will be placed by one operator. The restorations will be evaluated at baseline and at 6, 12, 18, and 24 months using modified USPHS criteria by one examiner. The restoration groups for each category will be compared using Pearson's chi-square test, while Cochran's Q test will be used to compare the changes across different time points within each restorative material (p\<0.05).
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
Randomly applied
Other: Tetric EvoCeram Bulkfill
Randomly applied
Other: Surefil SDR Flowable bulkfill
Randomly applied
Other: everX fiber-reinforced resin
The preparation will be etched with 37% phosphoric acid. It will be then rinsed with an air-water spray and dried, leaving the dentin slightly moist. An etch-and-rinse adhesive, ExciTE F, will be applied and agitated on the prepared surfaces for at least 10 seconds. The adhesive will be air-thinned and light-cured for 20 seconds with an LED curing unit. The sectional matrix will be placed and fixed with wooden wedges. Then the bulk-fill resin composite, TBF, will be placed in bulk in about 4-mm thickness and then will be cured for 20 seconds.
The preparation will be etched. A two-step etch-and-rinse adhesive, Prime\&Bond NT will be applied to all enamel/dentin surfaces, air-dried for 5 seconds, and will be light cured for 10 seconds. After the sectional matrix will be placed, the flowable bulk-fill resin composite, SureFil SDR™ flow (Dentsply Caulk, Milford, DE, USA), will be placed in a 4-mm bulk increment in the dentinal part cured for 20 seconds and will be followed by a covering layer of the nanohybrid resin composite, Ceram.X Mono that will be cured for 20 seconds.
The enamel will be etched with 37% phosphoric acid for 10 seconds, then will be rinsed, and dried with an air/water syringe for at least 5 seconds. Self-etch adhesive, G-aenial Bond (GC Co., Tokyo, Japan), will be applied to all enamel/dentin surfaces and gently air thinned and then will be light cured for 10 seconds. After the matrix will be placed and wedged, mesial or distal walls will be built with 1-2-mm layers of G-aenial Posterior resin composite. The fiber-reinforced composite, everX Posterior, will be placed into the cavity in approximately 4-mm thickness. The last 2 mm of the cavity will be restored using the G-aenial Posterior composite as an overlay layer. Each increment will be light cured for 20 seconds using an LED unit.
Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria
Long-term clinical success of different restorative resins in class II cavities on posterior teeth
Time frame: 2 years
Plan to share: No
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Hacettepe University