Three-Year Clinical Evaluation of Bonded Posterior Restorations: Amalgam vs Resin Composite
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ege University
- Enrollment
- 50
- Primary Endpoint
- Modified Ryge Criteria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Modified Ryge Criteria
Time Frame: 3 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Hande Kemaloglu
Dr
Ege University