Clinical Performance of a Glass-ionomer Restorative System: A 6-year Evaluation

Study Overview
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Brief Summary
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The aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in class I and class II cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct). Restorations were evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).

Detailed Description
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Since the introduction of glass ionomers many modifications of these materials have been performed over the years. Compared to other permanent filling materials like resin-based composites, glass ionomers show several advantages, such as the ability to adhere to moist enamel and dentin and anti-cariogenic properties such as the long-term fluoride release. So, it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based composites in posterior teeth.

Official Title
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Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations

Conditions
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Dental Caries

Intervention / Treatment
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* Other: EQUIA
* Other: Gradia Direct Posterior


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a need for at least two but not more than four posterior toothcolored restorations; the presence of teeth to be restored in occlusion; teeth that were symptomless and vital; a normal periodontal status; a good likelihood of recall availability. Exclusion Criteria: partly erupted teeth; absence of adjacent and antagonist teeth poor periodontal status; adverse medical history; potential behavioral problems.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EQUIA<br>randomly applied | Other: EQUIA<br>* Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.<br>* Other names: Glass ionomer restorative system;|
| Active Comparator: Gradia Direct Posterior<br>randomly applied | Other: Gradia Direct Posterior<br>* The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.<br>* Other names: Micro hybrid composite;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. | Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100µ) with discoloration (removable) Bravo: Marginal gap (> 100µ) with discoloration (unremovable) Charlie: The restoration is fractured or missed. | From baseline to 6 year the change of restorations was evaluated | 
| Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration. | Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction. | From baseline to 6 year the change of restorations was evaluated | 
| Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. | Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed | From baseline to 6 year the change of restorations was evaluated | 
| Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form. | Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture. | From baseline to 6 year the change of restorations was evaluated | 
| Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change. | Colour changes was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency. | From baseline to 6 year the change of restorations was evaluated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glass ionomer cement, composite resin