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Retrospective Evaluation of RMGI/GI Class V Restorations

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04401618
Enrollment
36
Registered
2020-05-26
Start date
2016-07-31
Completion date
2019-05-31
Last updated
2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Material, Dental

Keywords

Glass-Ionomer Cement, Polyacid-Modified Composite Resin, Dental School

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.

Interventions

OTHERRetrospective 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.

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-Operative Sensitivity2 yearsAbsence 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)
Secondary Caries2 yearsNo 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)
Anatomic Form2 yearsRestoration's anatomy is continuous with existing anatomic form of remaining tooth structure (checked visually with a dental intra-oral mirror)
Color match2 yearsNo difference between the tooth and restoration colour (checked visually with a dental intra-oral mirror)
Surface Roughness2 yearsSurface texture of the restoration is similar to tooth structure (manually checked with the tip of a dental hand instrument - explorer)
Marginal Discolouration2 yearsNo visual evidence of dark discolouration adjacent to the margins of the restoration (checked visually with a dental intra-oral mirror)
Marginal Integrity2 yearsRestoration closely adapted to the tooth. No crevice visible (manually checked with the tip of a dental hand instrument - explorer)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026