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

July 23, 2021 updated by: Suzanne E Fournier, Louisiana State University Health Sciences Center in New Orleans

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Lousiana State University Health Science Center, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration survival
Time Frame: 3 years
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
Time Frame: 3 years
Clinical performance based on criteria for posterior glass ionomer restorations
3 years
Additional Collection of Adverse Events Data
Time Frame: 3 years
Data collection of adverse events
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Collaborators

3M Oral Care

Investigators

  • Study Director: Mathilde C Peters, DMD, PhD, LSUHSC School of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 3, 2016

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSUHSC-NO #9270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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