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OpenTrials
Completed

NCT Number: NCT02705729

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

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

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lousiana State University Health Science Center, School of Dentistry

New Orleans, Louisiana, 70119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketac Universal

Device

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

Ketac Molar Quick

Device

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

Primary outcomes

  1. Restoration survival

    Time frame: 3 years

    Survival based on criteria for posterior glass ionomer restorations

Secondary outcomes

  1. Clinical Performance of restoration and restored tooth

    Time frame: 3 years

    Clinical performance based on criteria for posterior glass ionomer restorations

  2. Additional Collection of Adverse Events Data

    Time frame: 3 years

    Data collection of adverse events

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Collaborators

  • 3M Oral Care

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2016
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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