NCT02393989

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

March 10, 2015

Last Update Submit

March 16, 2015

Conditions

Class II Lesions

Outcome Measures

Primary Outcomes (1)

  • Modified Ryge Criteria

    3 years

Study Arms (1)

Active comparator

EXPERIMENTAL

posterior restorations

Procedure: posterior restoration

Interventions

posterior restorationPROCEDURE

restorations for caries effected teeth

Active comparator

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 20, 2015

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 20, 2015

Record last verified: 2015-03