Clinical Evaluation of a Dental Glass Ceramic in the Indirect Restorative Therapy

Study Overview
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Brief Summary
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A post market clinical follow up study (PMCF) with a glass ceramic to ensure the safety and efficacy of the product. It is a study with single-arm in which inlays and onlays for molars and premolars are adhesively luted.

Official Title
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Clinical Evaluation of a Dental Glass Ceramic in the Indirect Restorative Therapy

Conditions
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Caries, Dental Trauma

Intervention / Treatment
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* Device: indirect restorative treatement with a glass ceramic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 years Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth. Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information) Pre-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity Max. 2 restorations per participant in different quadrants. Healthy periodontium, no active periodontitis Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point. Sufficient language skills Exclusion Criteria: Sufficient isolation not possible, dry working field cannot be guaranteed Participants with a proven allergy to one of the ingredients of the materials used Participants with proven allergy to local anaesthetics High caries activity/ poor oral hygiene Participants with severe systemic diseases Pregnancy Symptoms of SARS-CoV2 infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: indirect restorative treatement with a glass ceramic|Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of inlays and onlays |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality Criteria (modified FDI criteria) | assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable (e.g. surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations) | Baseline to 5 years |