An interventional study of Glass Carbomer Cement and Composite Resin in Dental Caries Class II, sponsored by King Abdulaziz University. Completed. Open to participants aged 4 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by King Abdulaziz University · Not applicable, Interventional, and Treatment
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →King Abdulaziz University is the lead sponsor of 96 studies on the registry; 18 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands
Other: Glass Carbomer Cement
GC Fuji II LC Capsule, GC International, Tokyo, Japan
Other: Resin Modified Glass Ionomer Cement
Filtek Z250, 3M ESPE, St Paul, MN, USA
Other: Composite Resin
Restoration of proximal lesions in primary molars using glass carbomer cement
Also known as: GCP Glass Fill, Hydroxyapatite enhance glass ionomer cement
Restoration of proximal lesions in primary molars using composite resin.
Also known as: Filtek Z250
Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
Also known as: GC Fuji II LC Capsule
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.
Time frame: 2 Years
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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King Abdulaziz University