Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-11-30
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glass Carbomer Cement
GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands
Glass Carbomer Cement
Restoration of proximal lesions in primary molars using glass carbomer cement
Resin Modified Glass Ionomer Cement
GC Fuji II LC Capsule, GC International, Tokyo, Japan
Resin Modified Glass Ionomer Cement
Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
Composite Resin
Filtek Z250, 3M ESPE, St Paul, MN, USA
Composite Resin
Restoration of proximal lesions in primary molars using composite resin.
Interventions
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Glass Carbomer Cement
Restoration of proximal lesions in primary molars using glass carbomer cement
Composite Resin
Restoration of proximal lesions in primary molars using composite resin.
Resin Modified Glass Ionomer Cement
Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
10 Years
ALL
Yes
Sponsors
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King Abdulaziz University
OTHER
Responsible Party
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Sumaya Nouri
BDS, M.Sc
Principal Investigators
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Najlaa Alamoudi, MSc, DSc
Role: STUDY_CHAIR
King Abdulaziz University
References
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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.
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.
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.
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.
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.
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.
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.
Lucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.
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.
Related Links
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The longevity of dental restorations: a systematic review. Report 19, NHS Centre for Reviews and Dissemination
Other Identifiers
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070-16
Identifier Type: -
Identifier Source: org_study_id
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