NCT03030690

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries Class II

Interventions

Type	Name	Description
OTHER	Glass Carbomer Cement	Restoration of proximal lesions in primary molars using glass carbomer cement
OTHER	Composite Resin	Restoration of proximal lesions in primary molars using composite resin.
OTHER	Resin Modified Glass Ionomer Cement	Restoration of proximal lesions in primary molars using resin modified glass ionomer cement

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2017-01-25
• Last updated: 2018-03-07