Retrospective Evaluation of Posterior Direct Restorations

Sponsor

Western University, Canada (Other)

Overall Status

Completed

CT.gov ID

NCT04827823

Collaborator

(none)

Enrollment

Location

7.2

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries Class II	Other: Retrospective evaluation of amalgam and composite restorations

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 Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 10, 2017

Actual Primary Completion Date :

Sep 22, 2017

Actual Study Completion Date :

Dec 15, 2017

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schulich Medicine and Dentistry - Western University	London	Ontario	Canada	N6A5C1

Sponsors and Collaborators

Western University, Canada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Cetin AR, Unlu N, Cobanoglu N. A five-year clinical evaluation of direct nanofilled and indirect composite resin restorations in posterior teeth. Oper Dent. 2013 Mar-Apr;38(2):E1-11. doi: 10.2341/12-160-C. Epub 2012 Dec 5.

Responsible Party:

Western University, Canada

ClinicalTrials.gov Identifier:

NCT04827823

Other Study ID Numbers:

109006

First Posted:

Apr 1, 2021

Last Update Posted:

Apr 28, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Western University, Canada

Amalgam, Dental

Composite Resin

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Apr 28, 2021