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NCT02705729 Clinical Trial

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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02705729
Other study ID # LSUHSC-NO #9270
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2016
Est. completion date May 2021

Study information
Verified date July 2021
Source Louisiana State University Health Sciences Center in New Orleans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Ketac Universal
High-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step.
• Ketac Molar Quick
High-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step.

Locations
Country Name City State
United States Lousiana State University Health Science Center, School of Dentistry New Orleans Louisiana

Sponsors (2)
Lead Sponsor Collaborator
Louisiana State University Health Sciences Center in New Orleans 3M Oral Care

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Restoration survival Survival based on criteria for posterior glass ionomer restorations 3 years
Secondary Clinical Performance of restoration and restored tooth Clinical performance based on criteria for posterior glass ionomer restorations 3 years
Secondary Additional Collection of Adverse Events Data Data collection of adverse events 3 years
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