Three-Year Clinical Evaluation of Class II Posterior Composite Restorations

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858947
• Other study ID #: OMU-TAEK 2011/482
• Status: Completed
• Phase: N/A
• First received: July 26, 2016
• Last updated: August 3, 2016
• Start date: March 2011
• Est. completion date: January 2015

Study information

• Verified date: August 2016
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 41 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Procedure:
• Aelite Flo
Microhybrid flowable composite
• x-tra base
Bulk-fill flowable composite

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance evaluation of different composite resin restorations with USPHS criteria	Every year in three years period	three years	No