Retrospective Evaluation of RMGI/GI Class V Restorations

Retrospective Clinical Evaluation of RMGI/GI Class V Restorations Placed by Dental Students

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.

Study Overview

• Status: Completed
• Conditions: Material, Dental
• Intervention / Treatment: Other: Retrospective evaluation of RMGI and GIC Class V Restorations

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5C1
      • Schulich Medicine and Dentistry - Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Class V RMGI Restorations; Resin-modified glass ionomer (RMGI - Fuji 2 LC) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes.	Other: Retrospective evaluation of RMGI and GIC Class V Restorations; Retrospective evaluation of RMGI and GIC Class V Restorations that were placed by dental students over the last three years were evaluated using the modified USPHS criteria using mirrors and probes.
Class V Glass ionomer - GIC Restorations; Glass ionomer (GI - Fuji 9) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes.	Other: Retrospective evaluation of RMGI and GIC Class V Restorations; Retrospective evaluation of RMGI and GIC Class V Restorations that were placed by dental students over the last three years were evaluated using the modified USPHS criteria using mirrors and probes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Sensitivity	Absence of sensitivity to pressure, cold or hot temperature on the teeth restored (checked verbally by inquiring the patient about the presence or absence of pain in the presence of stimuli)	2 years
Secondary Caries	No visual evidence of dark, deep discolouration or cavitation adjacent to the restoration (visually and manually checked with the tip of a dental hand instrument - explorer)	2 years
Anatomic Form	Restoration's anatomy is continuous with existing anatomic form of remaining tooth structure (checked visually with a dental intra-oral mirror)	2 years
Color match	No difference between the tooth and restoration colour (checked visually with a dental intra-oral mirror)	2 years
Surface Roughness	Surface texture of the restoration is similar to tooth structure (manually checked with the tip of a dental hand instrument - explorer)	2 years
Marginal Discolouration	No visual evidence of dark discolouration adjacent to the margins of the restoration (checked visually with a dental intra-oral mirror)	2 years
Marginal Integrity	Restoration closely adapted to the tooth. No crevice visible (manually checked with the tip of a dental hand instrument - explorer)	2 years

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Maria Jacinta Santos, Ph.D, Schulich Dentistry-Western University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Glass-Ionomer Cement; Polyacid-Modified Composite Resin; Dental School
• Other Study ID Numbers: 107864

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No