Heated Glass Ionomer Cement in Primary Molars

Not Applicable

Completed

• Conditions: Glass-Ionomer Cement; Dental Caries; Primary Teeth
• Interventions: Other: Glass -Ionomer Cement with /without Led Light Cure

• Registration Number: NCT04291872
• Lead Sponsor: Marmara University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2016-08
• Study Completion: 2017-09
• Status Verified: 2020-02
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-28
• Last Update Submitted: 2020-02-28
• Study First Posted: 2020-03-02
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Heated Arm	Glass -Ionomer Cement with /without Led Light Cure	Proximal cavities were restored with Equia Forte (GC Corporation, Europe) according to manufacturer's orders.
Heated Arm	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.

Primary Outcome Measures

Name	Time	Method
Clinical success assessment measurement	12 months.	All restorations were evaluated by using Modified US Public Health Service criteria (modified USPHS criteria). Marginal Integrity (MI)), Marginal Discoloration (MD), Secondary Caries (SC), Anatomic Form (AF), and retention (R) were evaluated. A restoration was considered a failure when codes Charlie (C) and D (Delta) were registered. Codes A (Alpha) and B (Bravo) was considered a success or acceptable. follow up period was baseline, 6th months, 12th months.