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

NCT02888912 | Completed DMC

• 1 other identifier: HEK 09/112-10
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Dental Caries

Keywords

glass ionomer cement; composite resin

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

EQUIA

ACTIVE COMPARATOR

randomly applied

Other: EQUIA

Gradia Direct Posterior

ACTIVE COMPARATOR

randomly applied

Other: Gradia Direct Posterior

Interventions

EQUIA 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.

Also known as: Glass ionomer restorative system

EQUIA

Gradia Direct Posterior 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.

Also known as: Micro hybrid composite

Gradia Direct Posterior

Eligibility Criteria

• Age: 15 Years - 37 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• partly erupted teeth;
• absence of adjacent and antagonist teeth
• poor periodontal status;
• adverse medical history;
• potential behavioral problems.

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (1)

• 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.

  PMID: 25299703 RESULT

Related Links

• Pubmed

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sevil Gurgan, Phd, DDS

  Hacettepe University School of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 5, 2016
• Study Start: May 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 5, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share