Retrospective Evaluation of Posterior Direct Restorations

Dental Caries Class II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827823
• Other study ID #: 109006
• Status: Completed
• Start date: May 10, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: March 2021
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 15, 2017
• Est. primary completion date: September 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Class II

Intervention

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.

Locations

Country	Name	City	State
Canada	Schulich Medicine and Dentistry - Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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: — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Mjör 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. — View Citation

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: 10.1002/14 — View Citation

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. — View Citation

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: 10.1080/00016350 — View Citation

Outcome

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