Heated Glass Ionomer Cement in Primary Molars

NCT04291872 | Completed

• 1 other identifier: MarmaraU
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries; Glass-Ionomer Cement; Primary Teeth

Outcome Measures

Primary Outcomes (1)

• Clinical success assessment measurement

  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.

  12 months.

Study Arms (2)

Non-Heated Arm

EXPERIMENTAL

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

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

Heated Arm

EXPERIMENTAL

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.

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

Interventions

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.

Heated Arm; Non-Heated Arm

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Dental Caries

Interventions

Glass Ionomer Cements

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Control

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: March 2, 2020
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2017
• Last Updated: March 2, 2020

Record last verified: 2020-02