Clinical trial NCT04401618: Retrospective Evaluation of RMGI/GI Class V Restorations
Official title: Retrospective Clinical Evaluation of RMGI/GI Class V Restorations Placed by Dental Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Material, Dental
Keywords: Glass-Ionomer Cement
Polyacid-Modified Composite Resin
Dental School
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
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 that have Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students at the Schulich Dental Clinic over the last three years.

Brief summary: Brief Summary: Retrospective study to evaluate the clinical performance of two restorative materials - glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials - in Class V carious and non-carious cervical lesions restored by dental students.

Detailed description: The aim of this retrospective study was to evaluate the clinical performance of glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials in Class V carious and non-carious cervical lesions restored by dental students. Ninety-six (96) restorations performed with either GI (Fuji IX) (n=39) or RMGI (Fuji II) (n=57) were evaluated using the modified USPHS (United States Public Health Systems) criteria by two independent investigators at two follow-up evaluations (two years apart). The Fisher statistical test was used to compare USPHS criteria and examine significant differences by setting p\<0.05 for statistical significance and the Kaplan-Meier algorithm was used to calculate the survival probability.

Eligibility criteria: Inclusion Criteria:

• Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students over the last three years.

Exclusion Criteria:

* Class V Restorations placed outside of the dental school
* Class V Restorations that used other restorative materials Class V Ionomer restorations (RMGI and GIC0 placed before three years on the time of evaluation.

Primary outcomes:
measure: Post-Operative Sensitivity
timeFrame: 2 years
measure: Secondary Caries
timeFrame: 2 years
measure: Anatomic Form
timeFrame: 2 years
measure: Color match
timeFrame: 2 years
measure: Surface Roughness
timeFrame: 2 years
measure: Marginal Discolouration
timeFrame: 2 years
measure: Marginal Integrity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Schulich Medicine and Dentistry - Western University
state: Ontario
Study officials:
affiliation: Schulich Dentistry-Western University
name: Maria Jacinta Santos, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santos MJ, Ari N, Steele S, Costella J, Banting D. Retention of tooth-colored restorations in non-carious cervical lesions--a systematic review. Clin Oral Investig. 2014;18(5):1369-81. doi: 10.1007/s00784-014-1220-7. Epub 2014 Mar 27.
citation: Neo J, Chew CL, Yap A, Sidhu S. Clinical evaluation of tooth-colored materials in cervical lesions. Am J Dent. 1996 Feb;9(1):15-8.
citation: Franco EB, Benetti AR, Ishikiriama SK, Santiago SL, Lauris JR, Jorge MF, Navarro MF. 5-year clinical performance of resin composite versus resin modified glass ionomer restorative system in non-carious cervical lesions. Oper Dent. 2006 Jul-Aug;31(4):403-8. doi: 10.2341/05-87.
citation: van Dijken JW. Retention of a resin-modified glass ionomer adhesive in non-carious cervical lesions. A 6-year follow-up. J Dent. 2005 Aug;33(7):541-7. doi: 10.1016/j.jdent.2004.11.015. Epub 2005 Feb 8.
citation: Imbery TA, Namboodiri A, Duncan A, Amos R, Best AM, Moon PC. Evaluating dentin surface treatments for resin-modified glass ionomer restorative materials. Oper Dent. 2013 Jul-Aug;38(4):429-38. doi: 10.2341/12-162-L. Epub 2012 Oct 22.