Heated Glass Ionomer Cement in Primary Molars

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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Key information

Conditions

Dental Caries Glass-Ionomer Cement Primary Teeth Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glass -Ionomer Cement with /without Led Light Cure

Other

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 outcomes

Clinical success assessment measurement

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Mar 2, 2020
Registry last updated: Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed