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Clinical Performance of Glass Ionomer Versus Resin Composite Restorations

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dental restoration
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring restorative glass ionomer

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • good health and oral hygiene,
  • occlusal carious lesions on both mandibular second molars,
  • mandibular second molars with mesial and occlusal contacts,
  • contraindication to the use of rubber dam,
  • the ability to return for periodic follow-up visits.

Exclusion Criteria:

  • restoration on mandibular second molars.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    high-viscosity glass ionomer restoration

    nano-hybrid composite resin

    Arm Description

    One of the carious mandibular 2nd molar teeth (according to randomisation) will be restored with high-viscosity glass ionomer restoration (Equia, GC)

    One of the carious mandibular 2nd molar teeth will be restored with nano-hybrid composite resin (GrandioSO, Voco)

    Outcomes

    Primary Outcome Measures

    Surface lustre of dental restorations
    Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. Lustre comparable to enamel, 2. Slightly dull, not noticeable from speaking distance, 3.Dull surface but acceptable if covered with film of saliva, 4. Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary, 5. Very rough, unacceptable plaque retentive surface.).
    Staining restoration surface and restoration margin
    Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No surface staining, no marginal staining, 2. Minor surface staining, minor marginal staining easily removable by polishing, 3. oderate surface staining and moderate marginal staining that may also present on other teeth, not esthetically unacceptable, 4. Unacceptable surface staining on the restoration and major intervention necessary for improvement and Pronounced marginal staining; major intervention necessary for improvement, 5. Severe surface staining and/or subsurface staining, generalized or localized, not accessible for intervention and deep marginal staining, not accessible for intervention.).
    Fracture of material and retention
    Fracture of material and retention of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No fractures / cracks, 2. Small hairline crack. 3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact, 4. Material chip fractures which damage marginal quality or, approximal contacts. 5. (Partial or complete) loss of restoration or multiple fractures.).
    Recurrence of caries
    Recurrence of caries were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No secondary or primary caries 2. Small and localized. 3 Larger areas of 1. Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed Only preventive measures necessary 4. Caries with cavitation and suspected undermining caries Localized and accessible can be repaired, 5. Deep caries or exposed dentine that is not accessible for repair of restoration.)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2020
    Last Updated
    July 22, 2020
    Sponsor
    Tokat Gaziosmanpasa University
    Collaborators
    Izmir Katip Celebi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04488380
    Brief Title
    Clinical Performance of Glass Ionomer Versus Resin Composite Restorations
    Official Title
    Clinical Performance of Glass Ionomer Versus Resin Composite Restorations Performed Without Rubber-Dam Isolation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 12, 2015 (Actual)
    Primary Completion Date
    April 20, 2016 (Actual)
    Study Completion Date
    April 20, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tokat Gaziosmanpasa University
    Collaborators
    Izmir Katip Celebi University

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in patients at risk for salivary contamination.
    Detailed Description
    Occlusal carious lesions on the right and left mandibular second molars of 56 patients (26 females, 30 males) were restored in a split-mouth design. A high-viscosity glass ionomer (Hv-GIC) (Equia, GC) was used to restore the carious lesions in patients in the treatment group, while a nano-hybrid composite resin (GSO) (GrandioSO, Voco) was used for patients in the control group. Clinical evaluations of the restorations were performed at 1-week, 6-month, 1-year, and 2-year follow-up appointments, according to the FDI criteria. Data were analysed using the Friedman's analysis of variance and Mann-Whitney U tests (α=0.05).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    restorative glass ionomer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    One of the Glass ionomer restorative or Resin composite restorative materials were applied to carious mandibular 2nd molar teeth.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    high-viscosity glass ionomer restoration
    Arm Type
    Experimental
    Arm Description
    One of the carious mandibular 2nd molar teeth (according to randomisation) will be restored with high-viscosity glass ionomer restoration (Equia, GC)
    Arm Title
    nano-hybrid composite resin
    Arm Type
    Experimental
    Arm Description
    One of the carious mandibular 2nd molar teeth will be restored with nano-hybrid composite resin (GrandioSO, Voco)
    Intervention Type
    Other
    Intervention Name(s)
    dental restoration
    Intervention Description
    Restoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin
    Primary Outcome Measure Information:
    Title
    Surface lustre of dental restorations
    Description
    Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. Lustre comparable to enamel, 2. Slightly dull, not noticeable from speaking distance, 3.Dull surface but acceptable if covered with film of saliva, 4. Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary, 5. Very rough, unacceptable plaque retentive surface.).
    Time Frame
    Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
    Title
    Staining restoration surface and restoration margin
    Description
    Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No surface staining, no marginal staining, 2. Minor surface staining, minor marginal staining easily removable by polishing, 3. oderate surface staining and moderate marginal staining that may also present on other teeth, not esthetically unacceptable, 4. Unacceptable surface staining on the restoration and major intervention necessary for improvement and Pronounced marginal staining; major intervention necessary for improvement, 5. Severe surface staining and/or subsurface staining, generalized or localized, not accessible for intervention and deep marginal staining, not accessible for intervention.).
    Time Frame
    Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
    Title
    Fracture of material and retention
    Description
    Fracture of material and retention of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No fractures / cracks, 2. Small hairline crack. 3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact, 4. Material chip fractures which damage marginal quality or, approximal contacts. 5. (Partial or complete) loss of restoration or multiple fractures.).
    Time Frame
    Changes of dental restorations regarding Fracture of material and retention were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
    Title
    Recurrence of caries
    Description
    Recurrence of caries were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No secondary or primary caries 2. Small and localized. 3 Larger areas of 1. Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed Only preventive measures necessary 4. Caries with cavitation and suspected undermining caries Localized and accessible can be repaired, 5. Deep caries or exposed dentine that is not accessible for repair of restoration.)
    Time Frame
    Changes of dental restorations regarding recurrence of caries were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: good health and oral hygiene, occlusal carious lesions on both mandibular second molars, mandibular second molars with mesial and occlusal contacts, contraindication to the use of rubber dam, the ability to return for periodic follow-up visits. Exclusion Criteria: restoration on mandibular second molars.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31351909
    Citation
    Gurgan S, Kutuk ZB, Yalcin Cakir F, Ergin E. A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities. J Dent. 2020 Mar;94:103175. doi: 10.1016/j.jdent.2019.07.013. Epub 2019 Jul 25.
    Results Reference
    background
    PubMed Identifier
    27571238
    Citation
    Turkun LS, Kanik O. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis? Oper Dent. 2016 Nov/Dec;41(6):587-598. doi: 10.2341/15-331-C. Epub 2016 Aug 29.
    Results Reference
    background
    PubMed Identifier
    33683465
    Citation
    Hatirli H, Yasa B, Celik EU. Clinical performance of high-viscosity glass ionomer and resin composite on minimally invasive occlusal restorations performed without rubber-dam isolation: a two-year randomised split-mouth study. Clin Oral Investig. 2021 Sep;25(9):5493-5503. doi: 10.1007/s00784-021-03857-0. Epub 2021 Mar 8.
    Results Reference
    derived

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    Clinical Performance of Glass Ionomer Versus Resin Composite Restorations

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