Clinical Performance of a Glass-ionomer Restorative System in Extended-sized Cavities

Not Applicable

• Conditions: Dental Caries Class II
• Interventions: Other: Equia Forte; Other: G-aenial Posterior

• Registration Number: NCT02991664
• Lead Sponsor: Hacettepe University

Brief Summary

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 extended sized class II cavities. A total of 100 class 2 lesions were restored with a glass ionomer restorative system (Equia Forte) or a micro hybrid composite (G-aenial Posterior). 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

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.

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study First Submitted: 2016-12-10
• Study First Submitted QC: 2016-12-10
• Last Update Submitted: 2016-12-10
• Study First Posted: 2016-12-13
• Last Update Posted: 2016-12-13
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. a need for at least two but not more than four posterior toothcolored restorations;
2. the presence of teeth to be restored in occlusion;
3. teeth that were symptomless and vital;
4. a normal periodontal status;
5. a good likelihood of recall availability.

Exclusion Criteria

1. partly erupted teeth;
2. absence of adjacent and antagonist teeth
3. poor periodontal status;
4. adverse medical history;
5. potential behavioral problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Equia Forte, randomly applied	Equia Forte	Placing glass ionomer restorations, the dentin and enamel of cavities were washed, and briefly dried. Equia Forte 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 Forte Coat was applied and photocured for 20 seconds using a photo-curing light.
G-aenial Posterior, randomly applied	G-aenial Posterior	After etching procedure, the enamel and dentin were conditioned with G-aenial 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, G-aenial posterior composite 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.

Primary Outcome Measures

Name	Time	Method
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation.	From baseline to 6 year the change of restorations was evaluated	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.
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.	From baseline to 6 year the change of restorations was evaluated	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.
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate.	From baseline to 6 year the change of restorations was evaluated	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
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.	From baseline to 6 year the change of restorations was evaluated	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.
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change	From baseline to 6 year the change of restorations was evaluated	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 failedand 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.

Trial Locations

Locations (1)

Hacettepe University School of Dentistry; 🇹🇷 Ankara, Turkey