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

Louisiana State University

Status: Completed

Conditions: Dental Caries

Treatments: Device: Ketac Universal; Device: Ketac Molar Quick

Study type: Interventional

Funder types: Other

Identifiers

NCT02705729

LSUHSC-NO #9270

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Ketac Universal

Active Comparator group

Description:

Simplified glass ionomer tooth filling

Treatment:

Device: Ketac Universal

Ketac Molar Quick

Active Comparator group

Description:

Glass ionomer tooth filling

Treatment:

Device: Ketac Molar Quick