A Clinical Assessment of Glass Carbomer Cement
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|ClinicalTrials.gov Identifier: NCT03030690|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries Class II||Other: Glass Carbomer Cement Other: Composite Resin Other: Resin Modified Glass Ionomer Cement||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Experimental: Glass Carbomer Cement
GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands
Other: Glass Carbomer Cement
Restoration of proximal lesions in primary molars using glass carbomer cement
Active Comparator: Resin Modified Glass Ionomer Cement
GC Fuji II LC Capsule, GC International, Tokyo, Japan
Other: Resin Modified Glass Ionomer Cement
Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
Other Name: GC Fuji II LC Capsule
Active Comparator: Composite Resin
Filtek Z250, 3M ESPE, St Paul, MN, USA
Other: Composite Resin
Restoration of proximal lesions in primary molars using composite resin.
Other Name: Filtek Z250
- clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars. [ Time Frame: 2 Years ]the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030690
|Study Chair:||Najlaa Alamoudi, MSc, DSc||King Abdulaziz University|