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Completed

NCT Number: NCT02888912

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

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).

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

15 year–37 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Other names: Glass ionomer restorative system

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.

Other names: Micro hybrid composite

Primary outcomes

  1. Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation.

    Time frame: 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.

  2. Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.

    Time frame: 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.

  3. Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate.

    Time frame: 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

  4. Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.

    Time frame: 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.

  5. Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change.

    Time frame: 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 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2016
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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