Heated Glass Ionomer Cement in Primary Molars

Marmara University

Status: Completed

Conditions: Dental Caries; Glass-Ionomer Cement; Primary Teeth

Treatments: Other: Glass -Ionomer Cement with /without Led Light Cure

Study type: Interventional

Funder types: Other

Identifiers

NCT04291872

MarmaraU

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 5 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is mentally and systemically healthy
• Subject has at least two approximal carious lesions at both sides of jaws
• Subject has a normal occlusal relationship with natural dentition
• Subject has at least one adjacent tooth contact

Exclusion criteria

• Subject has history of bruxism,
• Subject has allergies to ingredients of glass ionomer based restorative materials.
• Cavity/Caries has highly mineralized pigmented lesions, hypoplasia, fracture or cracks,
• Subject has abrasion, erosion, abfraction,
• Subject has fistula, abscess or pathological mobility,
• Subject has pain, pulp exposure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Non-Heated Arm

Experimental group

Description:

Proximal cavities were restored with Equia Forte (GC Corporation, Europe) according to manufacturer's orders.

Treatment:

Other: Glass -Ionomer Cement with /without Led Light Cure

Heated Arm

Experimental group

Description:

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.

Treatment:

Other: Glass -Ionomer Cement with /without Led Light Cure