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NCT03030690 Clinical Trial

A Clinical Assessment of Glass Carbomer Cement

Dental Caries Class II Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03030690
Other study ID # 070-16
Secondary ID
Status Completed
Phase N/A
First received January 21, 2017
Last updated March 5, 2018
Start date November 2016
Est. completion date January 2018

Study information
Verified date March 2018
Source King Abdulaziz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 10 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
King Abdulaziz University

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Hübel S, Mejàre 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. — View Citation

Lucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.

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. — View 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. Epub 2007 Aug 25. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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Completed NCT06137989 - Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites N/A

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