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

NCT ID: NCT02393989

Last Updated: 2015-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Class II Lesions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active comparator

posterior restorations

Group Type EXPERIMENTAL

posterior restoration

Intervention Type PROCEDURE

restorations for caries effected teeth

Interventions

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posterior restoration

restorations for caries effected teeth

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Hande Kemaloglu

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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15-3/50

Identifier Type: -

Identifier Source: org_study_id

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