NCT04291872

Heated Glass Ionomer Cement in Primary Molars

Randomized Clinical Trial of Heated High-Viscosity Glass Ionomer Class II Restorations in Primary Molars: 12 Months Follow Up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Dental Caries
• Glass-Ionomer Cement
• Primary Teeth

Interventions

Type	Name	Description
OTHER	Glass -Ionomer Cement with /without Led Light Cure	Teeth were restored as same protocole with non-Heated Group. LED light (GC- D-Light DUO) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-08-01
• Completion: 2017-09-01
• First posted: 2020-03-02
• Last updated: 2020-03-02