Clinical Performance of Posterior Glass Ionomer Restorations in Adolescents (KETAC)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings.

Detailed Description
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In this post-market longitudinal prospective randomized control clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the efficacy of two high-strength glass ionomer restorative materials for a period of up to 3 years.

Official Title
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Clinical Performance of a Newly Developed Glass Ionomer Restorative Material for Posterior Restorations in an Adolescent Population

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Ketac Universal
* Device: Ketac Molar Quick


Participation Criteria
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Eligibility Criteria
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Criteria: Inclusion Criteria: needs 2 Class II posterior restorations in good health sufficient oral hygiene vital tooth caries in the outer and/or middle third of dentin teeth must have at least one proximal contact to be restored isthmus is less than half the intercuspal distance has one or more enamel-supported antagonistic contact. both study restorations are not in contact with each other Exclusion Criteria: pregnant or breast feeding erosion/eating disorders bruxism/traumatic malocclusion pulpitis cusp replacement radiographic bone loss/increased tooth mobility

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketac Universal<br>Simplified glass ionomer tooth filling | Device: Ketac Universal<br>* High-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step.<br>* Other names: Ketac Universal Aplicap Glass Ionomer Restorative;|
| Active Comparator: Ketac Molar Quick<br>Glass ionomer tooth filling | Device: Ketac Molar Quick<br>* High-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step.<br>* Other names: Ketac Molar Quick Aplicap Glass Ionomer Restorative;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration survival | Survival based on criteria for posterior glass ionomer restorations | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance of restoration and restored tooth | Clinical performance based on criteria for posterior glass ionomer restorations | 3 years | 
| Additional Collection of Adverse Events Data | Data collection of adverse events | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental caries, proximal surfaces, posterior teeth, carious lesions, tooth diseases, dental restorations, glass-ionomer