Retrospective Evaluation of Posterior Direct Restorations

April 26, 2021 updated by: Western University, Canada

Five-year Retrospective Clinical Evaluation of Multi-surface Amalgam and Resin Composite Restorations Placed by Dental Students

This retrospective study aims to evaluate the clinical performance of posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a five-year period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: The aim of this retrospective study is to evaluate the clinical performance of posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a five-year period. Materials and Methods: A total of 119 multi-surface Class II restorations (three or more surfaces) placed by third and fourth year students will be evaluated (AM: n = 69 and RC: n = 50). Restorations were assessed clinically according to the USPHS criteria by two independent evaluators using mirrors and probes. Data will be analyzed using Chisquare, Mann-Whitney and Wilcoxon tests at a 0.05 level of significance.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5C1
        • Schulich Medicine and Dentistry - Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults patients who had complex amalgam or resin composite restorations (three or more surfaces) placed on molar or premolar areas by dental students in the Adult Dental Clinic over a five-year period.

Description

Inclusion Criteria:

  • Presence of multi-surface (three or more surfaces) composite or amalgam restorations placed by dental students over a five-year period.

Exclusion Criteria:

  • Children
  • Restorations performed before or after five years on the time of evaluation
  • Restorations with fewer than 3 surfaces

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1- Amalgam restorations
Multi-surface amalgam restorations performed by dental students and are in function for about 5 years.
Other: Retrospective evaluation of amalgam and composite restorations
Multi-surface restorations that were performed by dental students and that are in function for the last five years will be clinically evaluated with mirrors and probes according to the modified USPHS criteria.
Group 2- Composite restorations
Multi-surface composite restorations performed by dental students and are in function for about 5 years.
Other: Retrospective evaluation of amalgam and composite restorations
Multi-surface restorations that were performed by dental students and that are in function for the last five years will be clinically evaluated with mirrors and probes according to the modified USPHS criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative sensitivity
Time Frame: 5 years
No Patient-reported sensitivity to hot and cold stimuli, sweets, clenching, and chewing related to the restoration (Alpha)
5 years
Secondary caries
Time Frame: 5 years
No visual evidence of dark, deep discoloration adjacent to the restoration (Alpha)
5 years
Proximal contact
Time Frame: 5 years
No open contact. Contact offers resistance to the dental floss (Alpha)
5 years
Marginal Adaptation
Time Frame: 5 years
Restoration closely adapted to the tooth. No crevice visible (Alpha)
5 years
Fracture restoration
Time Frame: 5 years
No evidence of fracture (Alpha)
5 years
Fracture tooth
Time Frame: 5 years
No evidence of fracture (Alpha)
5 years
Anatomy
Time Frame: 5 years
Restorations continuous with existing anatomic form (Alpha)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Actual)

September 22, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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