Three-Year Clinical Evaluation of Bonded Posterior Restorations: Amalgam vs Resin Composite

Not Applicable

Completed

• Conditions: Class II Lesions
• Interventions: Procedure: posterior restoration

• Registration Number: NCT02393989
• Lead Sponsor: Ege University

Brief Summary

Background: This 3-year clinical trial compared the performance and post-operative sensitivity of a posterior resin composite with that of bonded-amalgam in large sized cavities. Additionally, it was evaluated whether resin composite could be an alternative for bonded amalgam.

Methods: This was a randomized clinical trial. Patients in need of at least two posterior restorations were recruited. Authors randomly assigned one half of the restorations to receive bonded-amalgam and the other half to composite restorations. Forty bonded-amalgams and composites were evaluated for their performance on modified Ryge criteria and post-operative sensitivity using VAS for 36-months.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-03
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-16
• Last Update Submitted: 2015-03-16
• Study First Posted: 2015-03-20
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

To be included, the teeth to be restored had to:

1. be asymptomatic
2. have occlusal and adjacent teeth in contact
3. have cavity sizes exceeding the one-third of the bucco-lingual distance between cusp tips -

Exclusion Criteria

• Patients with periodontitis, poor oral hygiene, bruxism or a history of allergic reactions to any of the materials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active comparator	posterior restoration	posterior restorations

Primary Outcome Measures

Name	Time	Method
Modified Ryge Criteria	3 years