Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite

Hacettepe University

Status: Active, not recruiting

Conditions: Dental Caries

Treatments: Device: Nano-fill; Device: Bulk-fill

Study type: Interventional

Funder types: Other

Identifiers

NCT04320576

04(KA-15004)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 24 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Bulk-fill resin composite

Experimental group

Description:

Bulk-fill resin composite will be places with bulk technique.

Treatment:

Device: Bulk-fill

Nano-fill resin composite

Active Comparator group

Description:

Nano-fill resin composite will be placed with 2 mm thickness layering technique.

Treatment:

Device: Nano-fill