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6-year Clinical Evaluation of Glass Ionomer Cements (GIS) With Resin Coating on Posterior Teeth (GIS)

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EquiaFil G-coat
EquiaFil Fuji Varnish
Riva SC G-coat
Riva SC Fuji Varnish
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring glass ionomers, surface coating, clinical trial

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. having good oral hygiene;
  2. need for at least two or more posterior restorations in contact with neighbouring tooth and in occlusion with antagonist teeth;
  3. teeth planned to be restore should be vital and symptomless;
  4. the cavity isthmus size should be more than 1/3 of the intercuspal distance.

Exclusion Criteria:

  1. absence of adjacent and antagonist teeth;
  2. teeth with periodontal problems;
  3. teeth with preoperative pain or pulpal inflammations;
  4. teeth formerly subjected to direct pulp capping;
  5. patients having severe systemic diseases, allergies or adverse medical history.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    EquiaFil G-coat

    EquiaFil Fuji Varnish

    Riva SC G-coat

    Riva SC Fuji Varnish

    Arm Description

    EquiaFil G-coat combination was applied on one randomly selected cavity to be restored

    EquiaFil Fuji Varnish combination was applied on one randomly selected cavity to be restored

    River SC G-coat combination was applied on one randomly selected cavity to be restored

    River SC Fuji Varnish combination was applied on one randomly selected cavity to be restored

    Outcomes

    Primary Outcome Measures

    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding marginal adaptation by 2 independent evaluators
    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
    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding marginal discolouration by 2 independent evaluators
    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.
    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding retention rate by 2 independent evaluators
    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
    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding anatomic form by 2 independent evaluators
    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
    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding colour changes by 2 independent evaluators
    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.

    Secondary Outcome Measures

    Effects of resin coating on the performance of glass ionomer cements according to the United State Public Health Service criteria regarding marginal adaptation, marginal discolouration, retention rate, and colour changes by 2 independent evaluators
    The effect of different coatings on the clinical performance of the different glass ionomers tested was evaluated with United State Public Health Service criteria at baseline, 6-12-18 months and 6-years. For the evaluation 2 independent evaluators using dental problem and mirrors evaluated the resin coatings according to their retention, marginal adaptation, marginal discolouration, and colour match. There were 4 evaluation scores. Alpha meaning a perfect resin coating, Bravo meaning a coating partially effective but still clinically acceptable and Charlie and Delta meaning that the coating was partially to totally missed.

    Full Information

    First Posted
    November 20, 2015
    Last Updated
    November 24, 2015
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02616198
    Brief Title
    6-year Clinical Evaluation of Glass Ionomer Cements (GIS) With Resin Coating on Posterior Teeth
    Acronym
    GIS
    Official Title
    A Prospective 6-year Clinical Study Evaluating Reinforced Glass Ionomer Cements With Resin Coating on Posterior Teeth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ege University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study was to evaluate the long-term clinical performance of two highly viscous encapsulated GICs (EquiaFil and Riva SC) covered with two different coatings (Equia Coat and Fuji Varnish) over 6-year using modified United State Public Health Service (USPHS) criteria. A total of 256 restorations were made with EquiaFil and Riva SC. Equia Coat or Fuji Varnish was used randomly on the surface of the restorations. The restorations were evaluated at baseline, 6, 12, 18 months and 6 years after placement using modified USPHS criteria. The results were evaluated with Pearson Chi-Square and Mann Whitney U-test (p< 0.05).
    Detailed Description
    The aim of this study was to evaluate the long-term clinical performance of two highly viscous encapsulated GICs (EquiaFil and Riva SC) covered with two different coatings (Equia Coat and Fuji Varnish) over 6-year using modified United State Public Health Service (USPHS) criteria. Fifty-four patients having Class I and II restorations/caries were included in the study. A total of 256 restorations were made with EquiaFil (GC Corp, Japan) and Riva SC (SDI, Australia). Equia Coat or Fuji Varnish was used randomly on the surface of the restorations. After cavity preparations, the teeth were randomly restored with one glass ionomer cement and coated with Equia Coat or Fuji Varnish. The restorations were evaluated at baseline, 6, 12, 18 months and 6 years after placement using modified USPHS criteria. Two evaluators checked color-match, marginal discoloration, marginal adaptation, caries formation, anatomical form, postoperative sensitivity and retention rate and photographs were taken at each recalls. The results were evaluated with Pearson Chi-Square and Mann Whitney U-test (p< 0.05). The 18-month results were presented at the CED IADR congress iheld in Barcelona in 2010 (Turkun LS, & Kanic O ,Clinical evaluation of new glass ionomer coating combined systems for 18-months Journal of Dental Research 89 (Special Issue B) Abstract #402.) Gurgan S et al. also mentioned our 18-month results in their published manuscript ( Gurgan S,Kutuk ZB, Ergin E, Oztas ZZ & Cakir FY (2015) Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system Operative Dentistry 40(2) 134-143).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    glass ionomers, surface coating, clinical trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EquiaFil G-coat
    Arm Type
    Active Comparator
    Arm Description
    EquiaFil G-coat combination was applied on one randomly selected cavity to be restored
    Arm Title
    EquiaFil Fuji Varnish
    Arm Type
    Active Comparator
    Arm Description
    EquiaFil Fuji Varnish combination was applied on one randomly selected cavity to be restored
    Arm Title
    Riva SC G-coat
    Arm Type
    Active Comparator
    Arm Description
    River SC G-coat combination was applied on one randomly selected cavity to be restored
    Arm Title
    Riva SC Fuji Varnish
    Arm Type
    Active Comparator
    Arm Description
    River SC Fuji Varnish combination was applied on one randomly selected cavity to be restored
    Intervention Type
    Other
    Intervention Name(s)
    EquiaFil G-coat
    Intervention Description
    The old restorations or new caries were removed with anaesthetic solutions when necessary, a matrix was applied for two surface cavities and the restoration was performed with EquiaFil in bulk after mixing 10 sec. in the mixing machine. After 2min 30 sec, the restoration was contoured and the occlusion adjusted.Then the surface was coated with G-coat and light cured for 10 sec. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
    Intervention Type
    Other
    Intervention Name(s)
    EquiaFil Fuji Varnish
    Intervention Description
    The old restorations or carious lesions were removed with anaesthetic solutions when necessary, a matrix was applied for two surface cavities and the restoration was performed with EquiaFil in bulk after mixing in the mixing machine. After 2min 30 sec, the restoration was contoured and the occlusion adjusted.Then the surface was coated in 2 layers of Fuji Varnish. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
    Intervention Type
    Other
    Intervention Name(s)
    Riva SC G-coat
    Intervention Description
    The old restorations or carious lesions were removed and a sectional matrix was applied for two surface cavities and the restoration was performed with Riva SC in bulk after mixing 10 sec. in the mixing machine. The glass ionomer was packed with hand instruments in the cavities and 2min after the first setting the restoration was contoured and the occlusion adjusted.Then the surface was coated with G-coat resin and light cured for 10 sec. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
    Intervention Type
    Other
    Intervention Name(s)
    Riva SC Fuji Varnish
    Intervention Description
    The caries lesions were removed with diamond and stainless steel burs, a sectional matrix was applied for restoring two surface cavities and the restoration was performed with Riva SC in bulk after mixing 10 sec. in the mixing machine. After the first setting of 2min, the restoration was contoured and the occlusion adjusted.Then the surface was coated in 2 layers with Fuji Varnish. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
    Primary Outcome Measure Information:
    Title
    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding marginal adaptation by 2 independent evaluators
    Description
    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
    Time Frame
    6 years
    Title
    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding marginal discolouration by 2 independent evaluators
    Description
    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.
    Time Frame
    6 years
    Title
    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding retention rate by 2 independent evaluators
    Description
    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
    Time Frame
    6 years
    Title
    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding anatomic form by 2 independent evaluators
    Description
    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
    Time Frame
    6 years
    Title
    Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding colour changes by 2 independent evaluators
    Description
    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.
    Time Frame
    6 years
    Secondary Outcome Measure Information:
    Title
    Effects of resin coating on the performance of glass ionomer cements according to the United State Public Health Service criteria regarding marginal adaptation, marginal discolouration, retention rate, and colour changes by 2 independent evaluators
    Description
    The effect of different coatings on the clinical performance of the different glass ionomers tested was evaluated with United State Public Health Service criteria at baseline, 6-12-18 months and 6-years. For the evaluation 2 independent evaluators using dental problem and mirrors evaluated the resin coatings according to their retention, marginal adaptation, marginal discolouration, and colour match. There were 4 evaluation scores. Alpha meaning a perfect resin coating, Bravo meaning a coating partially effective but still clinically acceptable and Charlie and Delta meaning that the coating was partially to totally missed.
    Time Frame
    6 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: having good oral hygiene; need for at least two or more posterior restorations in contact with neighbouring tooth and in occlusion with antagonist teeth; teeth planned to be restore should be vital and symptomless; the cavity isthmus size should be more than 1/3 of the intercuspal distance. Exclusion Criteria: absence of adjacent and antagonist teeth; teeth with periodontal problems; teeth with preoperative pain or pulpal inflammations; teeth formerly subjected to direct pulp capping; patients having severe systemic diseases, allergies or adverse medical history.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21564113
    Citation
    Sidhu SK. Glass-ionomer cement restorative materials: a sticky subject? Aust Dent J. 2011 Jun;56 Suppl 1:23-30. doi: 10.1111/j.1834-7819.2010.01293.x.
    Results Reference
    background
    Citation
    Lohbauer U (2010) Dental glass ionomer cements as permanent filling materials? Properties, limitations and future trends. Materials 3(1) 76-96.
    Results Reference
    background
    PubMed Identifier
    23832616
    Citation
    Diem VT, Tyas MJ, Ngo HC, Phuong LH, Khanh ND. The effect of a nano-filled resin coating on the 3-year clinical performance of a conventional high-viscosity glass-ionomer cement. Clin Oral Investig. 2014 Apr;18(3):753-9. doi: 10.1007/s00784-013-1026-z. Epub 2013 Jul 7.
    Results Reference
    background
    PubMed Identifier
    19089080
    Citation
    Tyas MJ. Clinical evaluation of glass-ionomer cement restorations. J Appl Oral Sci. 2006;14 Suppl:10-3. doi: 10.1590/s1678-77572006000700003.
    Results Reference
    background
    PubMed Identifier
    20339470
    Citation
    Frankenberger R, Garcia-Godoy F, Kramer N. Clinical Performance of Viscous Glass Ionomer Cement in Posterior Cavities over Two Years. Int J Dent. 2009;2009:781462. doi: 10.1155/2009/781462. Epub 2010 Feb 22.
    Results Reference
    background
    PubMed Identifier
    17082278
    Citation
    Ersin NK, Candan U, Aykut A, Oncag O, Eronat C, Kose T. A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc. 2006 Nov;137(11):1529-36. doi: 10.14219/jada.archive.2006.0087.
    Results Reference
    background
    PubMed Identifier
    17546060
    Citation
    Burke FJ, Siddons C, Cripps S, Bardha J, Crisp RJ, Dopheide B. Clinical performance of reinforced glass ionomer restorations placed in UK dental practices. Br Dent J. 2007 Jul 14;203(1):E2; discussion 40-1. doi: 10.1038/bdj.2007.529. Epub 2007 Jun 1. Erratum In: Br Dent J. 2007 Sep 22;203(6):369. Phipps, S [corrected to Cripps, S].
    Results Reference
    background
    PubMed Identifier
    22149968
    Citation
    Bonifacio CC, Werner A, Kleverlaan CJ. Coating glass-ionomer cements with a nanofilled resin. Acta Odontol Scand. 2012 Dec;70(6):471-7. doi: 10.3109/00016357.2011.639307. Epub 2011 Dec 12.
    Results Reference
    background
    PubMed Identifier
    21840585
    Citation
    Friedl K, Hiller KA, Friedl KH. Clinical performance of a new glass ionomer based restoration system: a retrospective cohort study. Dent Mater. 2011 Oct;27(10):1031-7. doi: 10.1016/j.dental.2011.07.004. Epub 2011 Aug 15.
    Results Reference
    background
    Citation
    Basso M, Brambilla E, Benites MG, Giovannardi M & Ionescu AC (2015) Glass ionomer cement for permanent dental restorations: a 48-months, multi-center, prospective clinical trial Stomatology Education Journal 2(1) 25-35.
    Results Reference
    background
    Citation
    Miletic I, Baraba A, Juic IB & Anic I (2013) Evaluation of a glass-ionomer based restoration system- a one year pilot study Journal of Minimum Intervention in Dentistry 6 87-95.
    Results Reference
    background
    PubMed Identifier
    25299703
    Citation
    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.
    Results Reference
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    6-year Clinical Evaluation of Glass Ionomer Cements (GIS) With Resin Coating on Posterior Teeth

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