Three-Year Clinical Evaluation of Class II Posterior Composite Restorations

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

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-01-31

Brief Summary

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The aim of this study was to investigate the clinical effectiveness of direct resin composite restorations placed with different placement techniques (incremental or bulk) and with different flowable linings (conventional or bulk-fill flowable) used in open-sandwich technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal), in a randomized controlled comparison.

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Detailed Description

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Forty-seven pairs Class II (mesio-occlusal or disto-occlusal) composite restorations were placed in 37 patients. In all cavities, Adper Single Bond 2 was used. In one of the cavities of each pair, a conventional flowable composite, Aelite Flo, was applied in approximately 2mm thick, and the remaining cavity was restored incrementally with GrandioSO. In the second cavity, a bulk-fill flowable composite, x-tra base, was applied in approximately 4 mm thick in bulk increments and the remaining 2mm occlusal part of the cavity was restored with GrandioSO. All cavities were restored with open-sandwich technique by the same operator. At baseline and after 6-month, 1-, 2- and 3-year follow-up visits, restorations were evaluated by Modified USPHS criteria.

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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Aelite Flo

Microhybrid flowable composite

Group Type ACTIVE_COMPARATOR

Aelite Flo

Intervention Type PROCEDURE

Microhybrid flowable composite

x-tra base

Bulk-fill flowable composite

Group Type ACTIVE_COMPARATOR

x-tra base

Intervention Type PROCEDURE

Bulk-fill flowable composite

Interventions

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Aelite Flo

Microhybrid flowable composite

Intervention Type PROCEDURE

x-tra base

Bulk-fill flowable composite

Intervention Type PROCEDURE

Other Intervention Names

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1000006652 1145403

Eligibility Criteria

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Inclusion Criteria

* Permanent premolars and molars without any restorations were included in the study. Every tooth included in the study had neighboring teeth and were in occlusion to antagonistic teeth.

Exclusion Criteria

* Patients were excluded who needed indirect restorations due to significant loss of tooth structure, known allergies to product ingredients, had poor oral hygiene and a history of bruxism.

Minimum Eligible Age

19 Years

Maximum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes