Clincosm LogoSign in Get a demo

Clinical Performance Evaluation of a Glass-ionomer Restorative System Evaluation

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT03822403
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
116
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: EQUIA
  • Device: Gradia Direct Posterior
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized, Controlled Clinical Evaluation of Glass Ionomer System vs Composite Posterior Restorations
Actual Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: EQUIA

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.

Device: 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.
Other Names:
  • Glass ionomer restorative system

    		•
    Active Comparator: Gradia Direct Posterior

    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.

    Device: 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.
    Other Names:
  • Micro hybrid composite

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Marginal adaptation [From baseline to 9 year the change of restorations was evaluated]

      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)

    2. marginal discoloration [From baseline to 9 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

    3. retention rate [From baseline to 9 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

    4. anatomic form [From baseline to 9 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.

    5. color change [From baseline to 9 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University School of Dentistry Ankara Turkey 06100

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zeynep Bilge Kutuk, Assistant Professor, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT03822403
    Other Study ID Numbers:
    • HEK 09/112-11
    First Posted:
    Jan 30, 2019
    Last Update Posted:
    Jan 30, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zeynep Bilge Kutuk, Assistant Professor, Hacettepe University
    glass ionomer
    composite resin
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Jan 30, 2019