Clinical trial NCT04827823: Retrospective Evaluation of Posterior Direct Restorations
Official title: Five-year Retrospective Clinical Evaluation of Multi-surface Amalgam and Resin Composite Restorations Placed by Dental Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries Class II
Keywords: Amalgam, Dental
Composite Resin
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative sensitivity
timeFrame: 5 years
measure: Secondary caries
timeFrame: 5 years
measure: Proximal contact
timeFrame: 5 years
measure: Marginal Adaptation
timeFrame: 5 years
measure: Fracture restoration
timeFrame: 5 years
measure: Fracture tooth
timeFrame: 5 years
measure: Anatomy
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Schulich Medicine and Dentistry - Western University
state: Ontario
Study officials:
References:
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.
citation: 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.
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: 10.1080/00016350802577800.
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.
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: 10.1002/14651858.CD005620.pub2.
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.
citation: 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.
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 17.