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

NCT ID: NCT02705729

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-03

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketac Universal

Simplified glass ionomer tooth filling

Group Type ACTIVE_COMPARATOR

Ketac Universal

Intervention Type DEVICE

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

Ketac Molar Quick

Glass ionomer tooth filling

Group Type ACTIVE_COMPARATOR

Ketac Molar Quick

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketac Universal

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

Intervention Type DEVICE

Ketac Molar Quick

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ketac Universal Aplicap Glass Ionomer Restorative Ketac Molar Quick Aplicap Glass Ionomer Restorative

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

3M Oral Care

OTHER

Sponsor Role collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Suzanne E Fournier

Clinical Assistant Professor and Postgraduate Program Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mathilde C Peters, DMD, PhD

Role: STUDY_DIRECTOR

LSUHSC School of Dentistry

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lousiana State University Health Science Center, School of Dentistry

New Orleans, Louisiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LSUHSC-NO #9270

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.