Clinical Performance of Bioceramic vs High Viscosity GIC for Cervical Restorations of Geriatric Patients

Study Overview
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Brief Summary
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The aim of this study is to clinically evaluate the performance of the bioceramic glass ionomer compared to conventional high viscosity glass ionomer for restoration of carious cervical lesions in geriatric patients over 12 months follow up.

Official Title
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Clinical Performance of Bioactive Bioceramic Glass Ionomer Restorations vs Conventional High Viscous Glass Ionomer Restorations in Geriatric Patients With Carious Cervical Lesions: A One Year Randomized Clinical Trial.

Conditions
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Cervical Caries

Intervention / Treatment
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* Other: Bioceramic glass ionomer restoration
* Other: Resin modified glass ionomer restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Geriatric patients aged above 55 years Patients with untreated carious lesions Patients who have at least 20 teeth under occlusion 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. Non vital teeth. Teeth with signs or symptoms of pulpitis. Teeth with non carious lesions.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioceramic glass ionomer restoration<br>Calcium aluminate modified glass ionomer | Other: Bioceramic glass ionomer restoration<br>* bioactive glass ionomer with unique biocompatibility and biological regenerative properties<br>|
| Active Comparator: Resin modified glass ionomer restoration<br>type II resin modified glass ionomer cement | Other: Resin modified glass ionomer restoration<br>* A hybrid of glass ionomer and composite resin with acid-base and polymerizable components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Marginal adaptation score | Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical) | Baseline, 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Retention score | Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical) | Baseline, 3 months, 6 months, 12 months | 
| Change in Color match score | Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical) | Baseline, 3 months, 6 months, 12 months | 
| Change in Marginal discoloration score | Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical) | Baseline, 3 months, 6 months, 12 months | 
| Change in Secondary caries score | Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical) | Baseline, 3 months, 6 months, 12 months | 
| Change in Wear score | Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical) | Baseline, 3 months, 6 months, 12 months | 
| Change in Postoperative hypersensitivity score | Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical) | Baseline, 3 months, 6 months, 12 months |