An interventional study of Bulk-fill and Nano-fill in Dental Caries, sponsored by Hacettepe University. Active, not recruiting. Open to participants aged 24 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the clinical performance of a nano-fill and a bulk fill resin composite in class II restorations.
In accordance with a split-mouth design, 50 patients will be received at least one pair of restorations, restored with a nanofill resin composite (Filtek Ultimate [FU]) and with a bulk fill resin composite (Tetric EvoCeram Bulk Fill [TB]). Each restorative resin will be used with its respective adhesive system according to the manufacturers' instructions. A total of 104 class II restorations will be placed by two operators. The restorations will be blindly evaluated by two examiners at baseline and at 1-, 2-, 3-, 4-, 5-, 6-, 7- and 8- year using modified US Public Health Service Ryge criteria. The comparison of the two restorative materials for each category will be performed with the chi-square test (a=0.05). The baseline scores will be compared with those at the recall visits using the Cochran Q-test.
1,107 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 915 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.
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Exclusion Criteria:
Bulk-fill resin composite will be places with bulk technique.
Device: Bulk-fill
Nano-fill resin composite will be placed with 2 mm thickness layering technique.
Device: Nano-fill
Bulk-fill resin composite (bulk technique)
Nano-fill resin composite (layering technique)
Marginal adaptation
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation will evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable) Bravo: Marginal gap (\> 100μ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
Time frame: From baseline to 8 year the change of restorations will be evaluated
Marginal discoloration
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal discoloration. Marginal discoloration will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Time frame: From baseline to 8 year the change of restorations will be evaluated
Retention
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
Time frame: From baseline to 8 year the change of restorations will be evaluated
Anatomic form
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding anatomic form. Anatomic form will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
Time frame: From baseline to 8 year the change of restorations will be evaluated
Color change
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding color change. Color changes will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.
Time frame: From baseline to 8 year the change of restorations will be evaluated
No study locations are listed for this record.
This study is active, not recruiting, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Hacettepe University