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

NCT ID: NCT02888912

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2015-08-31

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 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

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

Study Design

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

Study Groups

EQUIA

randomly applied

Group Type: ACTIVE_COMPARATOR

EQUIA

Intervention Type: OTHER

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.

Gradia Direct Posterior

randomly applied

Group Type: ACTIVE_COMPARATOR

Gradia Direct Posterior

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Glass ionomer restorative system; Micro hybrid composite

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: 15 Years
• Maximum Eligible Age: 37 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, Phd, DDS

Role: STUDY_DIRECTOR

Hacettepe University School of Dentistry

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)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/25299703

Pubmed

Other Identifiers

HEK 09/112-10

Identifier Type: -

Identifier Source: org_study_id