Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)

Study Overview
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Brief Summary
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This research proposal is introduced to clinically test short fiber reinforced glass ionomer material from GC Europe due to gap of knowledge present in this area. It is characterized by higher flexural strength compared to resin modified glass ionomer (RMGIC). Additionally, the short fibers provided effective toughening of the RMGIC matrix by a fiber bridging mechanism.

Official Title
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Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations Versus Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)

Conditions
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Cervical Caries

Intervention / Treatment
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* Procedure: restoration of cervical carious teeth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with untreated cervical carious lesions Patients with normal occlusion Vital teeth with carious cervical lesion with asymptomatic vital pulp. Teeth with no or minimum mobility. Teeth with normal occlusion. Teeth with surrounding healthy gingiva and supporting-structures. Exclusion Criteria: Patients who are unable to return for recall appointments Presence of abnormal oral, medical or mental conditions. Patients with severe medical diseases. Patients with xerostomia Patients with parafunctional habits. Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Severe periodontal problems. Non carious cervical lesions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 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: Single Group Assignment
Interventional Model Description: split mouth
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short fiber reinforced resin modified glass ionomer restorations (GC Europe)<br> | Procedure: restoration of cervical carious teeth<br>* restoration of carious cervical lesions by glass ionomer<br>|
| Active Comparator: Resin modified glass ionomer restoration. (Fugi II LC, GC Europe)<br> | Procedure: restoration of cervical carious teeth<br>* restoration of carious cervical lesions by glass ionomer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Marginal integrity score | Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical) | [Time Frame: Baseline, 6 months, 12 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Marginal discoloration, Color match, Gross fracture scores | Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical) | [Time Frame: Baseline, 6 months, 12 months] | 
| Change in Secondary caries scores | Modified USPHS criteria with Alpha and Charlie scores (Categorical) | [Time Frame: Baseline, 6 months, 12 months] | 
| Change in Post operative Hypersensitivity | Modified USPHS criteria with Alpha and Charlie scores (Categorical) | [Time Frame: Baseline, 7 days, 6 months] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fiber reinforced glass ionomer