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Completed

NCT Number: NCT02858947

Three-Year Clinical Evaluation of Class II Posterior Composite Restorations

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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Key information

Age range

19 year–41 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aelite Flo

Procedure

Microhybrid flowable composite

Other names: 1000006652

x-tra base

Procedure

Bulk-fill flowable composite

Other names: 1145403

Primary outcomes

  1. Clinical performance evaluation of different composite resin restorations with USPHS criteria

    Time frame: three years

    Every year in three years period

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Three-Year Clinical Evaluation of Class II Posterior Composite Restorations Placed With Different Techniques and Flowable Composite Linings in Endodontically Treated Teeth

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Aug 8, 2016
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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