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

Louisiana State University Health Sciences Center in New Orleans60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dental Caries

Interventions

Ketac UniversalDEVICE

High-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step.

Ketac Molar QuickDEVICE

High-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Lousiana State University Health Science Center, School of Dentistry

New Orleans, Louisiana, United States

Outcomes

Primary Outcomes

Restoration survival

Survival based on criteria for posterior glass ionomer restorations

Time frame: 3 years

Secondary Outcomes

Clinical Performance of restoration and restored tooth

Clinical performance based on criteria for posterior glass ionomer restorations

Time frame: 3 years

Additional Collection of Adverse Events Data

Data collection of adverse events

Time frame: 3 years

Data from ClinicalTrials.gov

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