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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02393989

Enrollment

Registered

2015-03-20

Start date

2010-01-31

Completion date

2013-01-31

Last updated

2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Lesions

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.

Interventions

PROCEDUREposterior restoration

restorations for caries effected teeth

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Modified Ryge Criteria	3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026