Clinical trial NCT03030690: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries Class II
Keywords: Proximal Dental Caries
Glass Carbomer
Hydroxyapatite Enhanced Glass Ionomer
Primary Teeth
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Abdulaziz University
name: Najlaa Alamoudi, MSc, DSc
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
citation: Lucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.
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.