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

NCT ID: NCT02991664

Last Updated: 2016-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2021-12-31

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.

Conditions

Dental Caries Class II

Keywords

glass ionomer cement; composite resin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Equia Forte, randomly applied

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.

Group Type: ACTIVE_COMPARATOR

Equia Forte

Intervention Type: OTHER

Glass ionomer restorative system

G-aenial Posterior, randomly applied

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.

Group Type: ACTIVE_COMPARATOR

G-aenial Posterior

Intervention Type: OTHER

Micro hybrid composite resin

Interventions

Equia Forte

Glass ionomer restorative system

Intervention Type: OTHER

G-aenial Posterior

Micro hybrid composite resin

Intervention Type: OTHER

Other Intervention Names

Glass ionomer restorative system; Micro hybrid composite resin

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Bilge Kutuk

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevil Gurgan, Professor

Role: STUDY_DIRECTOR

Hacettepe University School of Dentistry

Locations

Hacettepe University School of Dentistry

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system. Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. Epub 2014 Oct 9.

Reference Type: RESULT

PMID: 25299703 (View on PubMed)

Other Identifiers

Equia Forte_G-aenial Posterior

Identifier Type: -

Identifier Source: org_study_id