Clinical Performance Evaluation of a Glass-ionomer Restorative System Evaluation

Hacettepe University

Status: Completed

Conditions: Dental Caries

Treatments: Device: EQUIA; Device: Gradia Direct Posterior

Study type: Interventional

Funder types: Other

Identifiers

NCT03822403

HEK 09/112-11

Details and patient eligibility

About

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 9 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

EQUIA

Active Comparator group

Description:

EQUIA 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.

Treatment:

Device: EQUIA

Gradia Direct Posterior

Active Comparator group

Description:

Gradia Direct Posterior 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.

Treatment:

Device: Gradia Direct Posterior