Dental Caries Clinical Trial
Official title:
Randomized Clinical Trial of Heated High-Viscosity Glass Ionomer Class II Restorations in Primary Molars: 12 Months Follow Up
Objective: The aim of this study was to assess the influence of heated in the clinical
success of proximal high viscosity glass ionomer cement (GIC) restorations in primary molars.
Material & Method: This randomized, split mouth, multicenter study was performed in four
different centers including 88 patients aged between 5-7 years old. Selection criteria
included clinically and/or radiographically detected proximal caries extending into the
dentin tissue. A total of 250 primary molars were restored with a bulk fill GIC (Equia Forte,
GC, Europe) and randomly allocated to one of the following groups: 1) non-heated (n = 125)
and 2) heated (n = 125). LED light (GC- D-Light DUO, Tokyo Japan) was used at standard mode
1200 mW/cm2, at 50-60 ºC, for 60 sec for heat application. All restorations were clinically
evaluated using modified USPHS criteria at the baseline, 6 months and 12 months. Chi-square
test, Fisher's Exact Chi-square test, Continuity (Yates) correction, Fisher Freeman Halton
test and Mc Nemar test were used to compare qualitative data with descriptive statistical
methods (frequency). Kaplan Meier and Life Tables were used for survival analysis. P value <
0.05 was considered statistically significant.
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