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Completed

NCT Number: NCT04827823

Retrospective Evaluation of Posterior Direct Restorations

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.

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Key information

Conditions

Dental Caries Class II

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schulich Medicine and Dentistry - Western University

London, Ontario, N6A5C1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective evaluation of amalgam and composite restorations

Other

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.

Primary outcomes

  1. Postoperative sensitivity

    Time frame: 5 years

    No Patient-reported sensitivity to hot and cold stimuli, sweets, clenching, and chewing related to the restoration (Alpha)

  2. Secondary caries

    Time frame: 5 years

    No visual evidence of dark, deep discoloration adjacent to the restoration (Alpha)

  3. Proximal contact

    Time frame: 5 years

    No open contact. Contact offers resistance to the dental floss (Alpha)

  4. Marginal Adaptation

    Time frame: 5 years

    Restoration closely adapted to the tooth. No crevice visible (Alpha)

  5. Fracture restoration

    Time frame: 5 years

    No evidence of fracture (Alpha)

  6. Fracture tooth

    Time frame: 5 years

    No evidence of fracture (Alpha)

  7. Anatomy

    Time frame: 5 years

    Restorations continuous with existing anatomic form (Alpha)

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2021
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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