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Completed

NCT Number: NCT02393989

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

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.

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Key information

Conditions

Class II Lesions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

  • be asymptomatic
  • have occlusal and adjacent teeth in contact
  • 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

Treatment and study plan

posterior restoration

Procedure

restorations for caries effected teeth

Primary outcomes

  1. Modified Ryge Criteria

    Time frame: 3 years

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Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2015
Registry last updated
Mar 20, 2015

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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