A Clinical Assessment of Glass Carbomer Cement

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Assessment of Class II Glass Carbomer Cement Restorations Compared to Resin Modified Glass Ionomer Cement and Composite Resin Restorations in Primary Molars.

Conditions
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Dental Caries Class II

Intervention / Treatment
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* Other: Glass Carbomer Cement
* Other: Composite Resin
* Other: Resin Modified Glass Ionomer Cement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glass Carbomer Cement<br>GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands | Other: Glass Carbomer Cement<br>* Restoration of proximal lesions in primary molars using glass carbomer cement<br>* Other names: Hydroxyapatite enhance glass ionomer cement;|
| Active Comparator: Resin Modified Glass Ionomer Cement<br>GC Fuji II LC Capsule, GC International, Tokyo, Japan | Other: Resin Modified Glass Ionomer Cement<br>* Restoration of proximal lesions in primary molars using resin modified glass ionomer cement<br>* Other names: GC Fuji II LC Capsule;|
| Active Comparator: Composite Resin<br>Filtek Z250, 3M ESPE, St Paul, MN, USA | Other: Composite Resin<br>* Restoration of proximal lesions in primary molars using composite resin.<br>* Other names: Filtek Z250;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal Dental Caries, Glass Carbomer, Hydroxyapatite Enhanced Glass Ionomer, Primary Teeth