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A Clinical Assessment of Glass Carbomer Cement

Primary Purpose

Dental Caries Class II

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glass Carbomer Cement
Composite Resin
Resin Modified Glass Ionomer Cement
Sponsored by
King Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries Class II focused on measuring Proximal Dental Caries, Glass Carbomer, Hydroxyapatite Enhanced Glass Ionomer, Primary Teeth

Eligibility Criteria

4 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • One proximal lesion in a primary molar.
  • Radiographic evidence of caries extending at least into the inner half of the enamel but not the inner half of dentin.
  • Proximal contact with adjacent healthy or restored teeth.
  • Occlusal contact with opposing healthy or restored teeth.
  • No indication for pulp therapy or other restorative treatment.
  • A predicted survival until exfoliation of 2 years.

Exclusion Criteria:

  • Radiographic evidence of caries extending into the inner half of dentin.
  • No proximal contact with adjacent healthy or restored teeth.
  • No occlusal contact with opposing healthy or restored teeth.
  • Tooth indicated for pulp therapy or other restorative treatment.
  • A predicted survival until exfoliation of less than 2 years.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Glass Carbomer Cement

    Resin Modified Glass Ionomer Cement

    Composite Resin

    Arm Description

    GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands

    GC Fuji II LC Capsule, GC International, Tokyo, Japan

    Filtek Z250, 3M ESPE, St Paul, MN, USA

    Outcomes

    Primary Outcome Measures

    clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.
    the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 21, 2017
    Last Updated
    March 5, 2018
    Sponsor
    King Abdulaziz University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03030690
    Brief Title
    A Clinical Assessment of Glass Carbomer Cement
    Official Title
    A Clinical Assessment of Class II Glass Carbomer Cement Restorations Compared to Resin Modified Glass Ionomer Cement and Composite Resin Restorations in Primary Molars.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the clinical performance of glass carbomer cement restorations in restoring proximal lesions in primary molars compared to that of resin modified glass ionomer cement and composite resin restorations. Teeth will be randomly assigned to one of the three restoration groups and the restorations will be evaluated clinically and radiographically every six months.
    Detailed Description
    Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from traditional glass ionomer cement (GIC) and contains nano-sized powder particles of hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties and better bonding to dentin, in addition to continues fluoride release. The study is a randomized controlled clinical trial where teeth will be randomly assigned to one of the three restoration groups. Following medical and dental history, bilateral bitewing radiographs will be taken for each patient to assess the presence of proximal lesions. Suitable teeth will then be randomly assigned to one of the restoration groups. A single operator using local anesthesia and rubber dam isolation will then prepare standardized Class II cavities and place the designated restorations according to the manufacturer's instructions. The quality of the 3 types of restorations will be clinically evaluated at baseline and every six months for color match, marginal discoloration, anatomic form, marginal adaptation, and secondary caries using the criteria described by "Cvar and Ryge" (2005). The evaluation will be performed by 2 calibrated examiners. Following placement of the restorations, bitewing radiographs will be taken to evaluate the restorations and will be repeated every six months for detection of recurrent caries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries Class II
    Keywords
    Proximal Dental Caries, Glass Carbomer, Hydroxyapatite Enhanced Glass Ionomer, Primary Teeth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glass Carbomer Cement
    Arm Type
    Experimental
    Arm Description
    GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands
    Arm Title
    Resin Modified Glass Ionomer Cement
    Arm Type
    Active Comparator
    Arm Description
    GC Fuji II LC Capsule, GC International, Tokyo, Japan
    Arm Title
    Composite Resin
    Arm Type
    Active Comparator
    Arm Description
    Filtek Z250, 3M ESPE, St Paul, MN, USA
    Intervention Type
    Other
    Intervention Name(s)
    Glass Carbomer Cement
    Other Intervention Name(s)
    GCP Glass Fill, Hydroxyapatite enhance glass ionomer cement
    Intervention Description
    Restoration of proximal lesions in primary molars using glass carbomer cement
    Intervention Type
    Other
    Intervention Name(s)
    Composite Resin
    Other Intervention Name(s)
    Filtek Z250
    Intervention Description
    Restoration of proximal lesions in primary molars using composite resin.
    Intervention Type
    Other
    Intervention Name(s)
    Resin Modified Glass Ionomer Cement
    Other Intervention Name(s)
    GC Fuji II LC Capsule
    Intervention Description
    Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
    Primary Outcome Measure Information:
    Title
    clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.
    Description
    the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.
    Time Frame
    2 Years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: One proximal lesion in a primary molar. Radiographic evidence of caries extending at least into the inner half of the enamel but not the inner half of dentin. Proximal contact with adjacent healthy or restored teeth. Occlusal contact with opposing healthy or restored teeth. No indication for pulp therapy or other restorative treatment. A predicted survival until exfoliation of 2 years. Exclusion Criteria: Radiographic evidence of caries extending into the inner half of dentin. No proximal contact with adjacent healthy or restored teeth. No occlusal contact with opposing healthy or restored teeth. Tooth indicated for pulp therapy or other restorative treatment. A predicted survival until exfoliation of less than 2 years.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Najlaa Alamoudi, MSc, DSc
    Organizational Affiliation
    King Abdulaziz University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22300651
    Citation
    Chen X, Du MQ, Fan MW, Mulder J, Huysmans MC, Frencken JE. Caries-preventive effect of sealants produced with altered glass-ionomer materials, after 2 years. Dent Mater. 2012 May;28(5):554-60. doi: 10.1016/j.dental.2012.01.001. Epub 2012 Jan 31.
    Results Reference
    background
    PubMed Identifier
    22124610
    Citation
    Chen X, Du M, Fan M, Mulder J, Huysmans MC, Frencken JE. Effectiveness of two new types of sealants: retention after 2 years. Clin Oral Investig. 2012 Oct;16(5):1443-50. doi: 10.1007/s00784-011-0633-9. Epub 2011 Nov 29.
    Results Reference
    background
    PubMed Identifier
    16315023
    Citation
    Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
    Results Reference
    background
    PubMed Identifier
    25134364
    Citation
    Gorseta K, Glavina D, Borzabadi-Farahani A, Van Duinen RN, Skrinjaric I, Hill RG, Lynch E. One-year clinical evaluation of a Glass Carbomer fissure sealant, a preliminary study. Eur J Prosthodont Restor Dent. 2014 Jun;22(2):67-71.
    Results Reference
    background
    PubMed Identifier
    15350775
    Citation
    Gu YW, Yap AU, Cheang P, Khor KA. Effects of incorporation of HA/ZrO(2) into glass ionomer cement (GIC). Biomaterials. 2005 Mar;26(7):713-20. doi: 10.1016/j.biomaterials.2004.03.019.
    Results Reference
    background
    PubMed Identifier
    12542617
    Citation
    Hubel S, Mejare I. Conventional versus resin-modified glass-ionomer cement for Class II restorations in primary molars. A 3-year clinical study. Int J Paediatr Dent. 2003 Jan;13(1):2-8. doi: 10.1046/j.1365-263x.2003.00416.x.
    Results Reference
    background
    PubMed Identifier
    12818551
    Citation
    Lucas ME, Arita K, Nishino M. Toughness, bonding and fluoride-release properties of hydroxyapatite-added glass ionomer cement. Biomaterials. 2003 Sep;24(21):3787-94. doi: 10.1016/s0142-9612(03)00260-6.
    Results Reference
    background
    Citation
    Lucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.
    Results Reference
    background
    PubMed Identifier
    17921077
    Citation
    Moshaverinia A, Ansari S, Moshaverinia M, Roohpour N, Darr JA, Rehman I. Effects of incorporation of hydroxyapatite and fluoroapatite nanobioceramics into conventional glass ionomer cements (GIC). Acta Biomater. 2008 Mar;4(2):432-40. doi: 10.1016/j.actbio.2007.07.011. Epub 2007 Aug 25.
    Results Reference
    background
    Links:
    URL
    https://www.york.ac.uk/media/crd/crdreport19.pdf
    Description
    The longevity of dental restorations: a systematic review. Report 19, NHS Centre for Reviews and Dissemination

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    A Clinical Assessment of Glass Carbomer Cement

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