Dental Caries
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBulk-fill
Bulk-fill resin composite (bulk technique)
DEVICENano-fill
Nano-fill resin composite (layering technique)
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* a need for at least two but not more than four posterior tooth-colored restorations * the presence of teeth to be restored in occlusion * teeth that were symptomless and vital * a normal periodontal status * a good likelihood of recall availability.
Exclusion criteria
* partly erupted teeth * absence of adjacent and antagonist teeth * poor periodontal status * adverse medical history * potential behavioral problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal adaptation | From baseline to 8 year the change of restorations will be evaluated | 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. |
| Marginal discoloration | From baseline to 8 year the change of restorations will be evaluated | 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. |
| Retention | From baseline to 8 year the change of restorations will be evaluated | 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 |
| Anatomic form | From baseline to 8 year the change of restorations will be evaluated | 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. |
| Color change | From baseline to 8 year the change of restorations will be evaluated | 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. |
Outcome results
None listed