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.
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.
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.
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