Three-Year Clinical Evaluation of Class II Posterior Composite Restorations

Study Overview
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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.

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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: Aelite Flo
* Procedure: x-tra base


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aelite Flo<br>Microhybrid flowable composite | Procedure: Aelite Flo<br>* Microhybrid flowable composite<br>* Other names: 1000006652;|
| Active Comparator: x-tra base<br>Bulk-fill flowable composite | Procedure: x-tra base<br>* Bulk-fill flowable composite<br>* Other names: 1145403;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance evaluation of different composite resin restorations with USPHS criteria | Every year in three years period | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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composite resin, bulk-fill, teeth endodontically-treated