Retrospective Evaluation of Posterior Direct Restorations

NCT04827823 | Completed

• 1 other identifier: 109006
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries Class II

Keywords

Amalgam, Dental; Composite Resin

Outcome Measures

Primary Outcomes (7)

• Postoperative sensitivity

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

  5 years

• Secondary caries

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

  5 years

• Proximal contact

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

  5 years

• Marginal Adaptation

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

  5 years

• Fracture restoration

  No evidence of fracture (Alpha)

  5 years

• Fracture tooth

  No evidence of fracture (Alpha)

  5 years

• Anatomy

  Restorations continuous with existing anatomic form (Alpha)

  5 years

Study Arms (2)

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

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

Interventions

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.

Group 1- Amalgam restorations; Group 2- Composite restorations

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Schulich Medicine and Dentistry - Western University

London, Ontario, N6A5C1, Canada

Location

Related Publications (8)

• 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.

  PMID: 23215545 BACKGROUND

• Mjor IA, Jokstad A. Five-year study of Class II restorations in permanent teeth using amalgam, glass polyalkenoate (ionomer) cerment and resin-based composite materials. J Dent. 1993 Dec;21(6):338-43. doi: 10.1016/0300-5712(93)90006-c.

  PMID: 8258583 RESULT

• Vidnes-Kopperud S, Tveit AB, Gaarden T, Sandvik L, Espelid I. Factors influencing dentists' choice of amalgam and tooth-colored restorative materials for Class II preparations in younger patients. Acta Odontol Scand. 2009;67(2):74-9. doi: 10.1080/00016350802577800.

  PMID: 19085213 RESULT

• Correa MB, Peres MA, Peres KG, Horta BL, Barros AD, Demarco FF. Amalgam or composite resin? Factors influencing the choice of restorative material. J Dent. 2012 Sep;40(9):703-10. doi: 10.1016/j.jdent.2012.04.020. Epub 2012 Apr 28.

  PMID: 22546263 RESULT

• Rasines Alcaraz MG, Veitz-Keenan A, Sahrmann P, Schmidlin PR, Davis D, Iheozor-Ejiofor Z. Direct composite resin fillings versus amalgam fillings for permanent or adult posterior teeth. Cochrane Database Syst Rev. 2014 Mar 31;(3):CD005620. doi: 10.1002/14651858.CD005620.pub2.

  PMID: 24683067 RESULT

• Rho YJ, Namgung C, Jin BH, Lim BS, Cho BH. Longevity of direct restorations in stress-bearing posterior cavities: a retrospective study. Oper Dent. 2013 Nov-Dec;38(6):572-82. doi: 10.2341/12-432-C. Epub 2013 Apr 3.

  PMID: 23550914 RESULT

• Beck F, Lettner S, Graf A, Bitriol B, Dumitrescu N, Bauer P, Moritz A, Schedle A. Survival of direct resin restorations in posterior teeth within a 19-year period (1996-2015): A meta-analysis of prospective studies. Dent Mater. 2015 Aug;31(8):958-85. doi: 10.1016/j.dental.2015.05.004. Epub 2015 Jun 16.

  PMID: 26091581 RESULT

• Borgia E, Baron R, Borgia JL. Quality and Survival of Direct Light-Activated Composite Resin Restorations in Posterior Teeth: A 5- to 20-Year Retrospective Longitudinal Study. J Prosthodont. 2019 Jan;28(1):e195-e203. doi: 10.1111/jopr.12630. Epub 2017 May 17.

  PMID: 28513897 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: May 10, 2017
• Primary Completion: September 22, 2017
• Study Completion: December 15, 2017
• Last Updated: April 28, 2021

Record last verified: 2021-03

Locations

CA (1)