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

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ClinicalTrials.gov Identifier: NCT02991664
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Zeynep Bilge Kutuk, Hacettepe University

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).

Condition or disease Intervention/treatment Phase
Dental Caries Class II Other: Equia Forte Other: G-aenial Posterior Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations in Extended Sized Class 2 Cavities
Study Start Date : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2021

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MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: 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.
Other: Equia Forte
Glass ionomer restorative system
Other Name: Glass ionomer restorative system

Active Comparator: 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.
Other: G-aenial Posterior
Micro hybrid composite resin
Other Name: Micro hybrid composite resin




Primary Outcome Measures :
  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 failedand 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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991664


Locations
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Turkey
Hacettepe University School of Dentistry
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Study Director: Sevil Gurgan, Professor Hacettepe University School of Dentistry
Publications of Results:
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Responsible Party: Zeynep Bilge Kutuk, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier: NCT02991664    
Other Study ID Numbers: Equia Forte_G-aenial Posterior
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zeynep Bilge Kutuk, Hacettepe University:
glass ionomer cement
composite resin
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases