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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02705729

Enrollment

Registered

2016-03-10

Start date

2016-08-03

Completion date

2021-05-31

Last updated

2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

dental caries, proximal surfaces, posterior teeth, carious lesions, tooth diseases, dental restorations, glass-ionomer

Brief summary

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

Detailed description

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.

Interventions

DEVICEKetac Universal

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

DEVICEKetac Molar Quick

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Restoration survival	3 years	Survival based on criteria for posterior glass ionomer restorations

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026