A Clinical Assessment of Glass Carbomer Cement
A Clinical Assessment of Class II Glass Carbomer Cement Restorations Compared to Resin Modified Glass Ionomer Cement and Composite Resin Restorations in Primary Molars.
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 21, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMarch 7, 2018
March 1, 2018
1.2 years
January 21, 2017
March 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 Years
Study Arms (3)
Glass Carbomer Cement
EXPERIMENTALGCP Glass Fill, Glass Carbomerâ„¢Tech, Ridderkerk, Netherlands
Resin Modified Glass Ionomer Cement
ACTIVE COMPARATORGC Fuji II LC Capsule, GC International, Tokyo, Japan
Composite Resin
ACTIVE COMPARATORFiltek Z250, 3M ESPE, St Paul, MN, USA
Interventions
Restoration of proximal lesions in primary molars using glass carbomer cement
Restoration of proximal lesions in primary molars using composite resin.
Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (9)
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.
PMID: 22300651BACKGROUNDChen 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.
PMID: 22124610BACKGROUNDCvar 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.
PMID: 16315023BACKGROUNDGorseta 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.
PMID: 25134364BACKGROUNDGu 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.
PMID: 15350775BACKGROUNDHubel 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.
PMID: 12542617BACKGROUNDLucas 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.
PMID: 12818551BACKGROUNDLucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.
BACKGROUNDMoshaverinia 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.
PMID: 17921077BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Najlaa Alamoudi, MSc, DSc
King Abdulaziz University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- BDS, M.Sc
Study Record Dates
First Submitted
January 21, 2017
First Posted
January 25, 2017
Study Start
November 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
March 7, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share