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

NCT ID: NCT04320576

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2025-05-01

Brief Summary

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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

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bulk-fill resin composite

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

Group Type EXPERIMENTAL

Bulk-fill

Intervention Type DEVICE

Bulk-fill resin composite (bulk technique)

Nano-fill resin composite

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

Group Type ACTIVE_COMPARATOR

Nano-fill

Intervention Type DEVICE

Nano-fill resin composite (layering technique)

Interventions

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Bulk-fill

Bulk-fill resin composite (bulk technique)

Intervention Type DEVICE

Nano-fill

Nano-fill resin composite (layering technique)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

24 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Bilge Kutuk

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse R Yazici, DDS, PhD

Role: STUDY_DIRECTOR

Hacettepe University School of Dentistry

Related Links

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Other Identifiers

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04(KA-15004)

Identifier Type: -

Identifier Source: org_study_id

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