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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Device: Ketac Universal; Device: Ketac Molar Quick

• Registration Number: NCT02705729
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-10
• Study Start: 2016-08-03
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketac Universal	Ketac Universal	Simplified glass ionomer tooth filling
Ketac Molar Quick	Ketac Molar Quick	Glass ionomer tooth filling

Primary Outcome Measures

Name	Time	Method
Restoration survival	3 years	Survival based on criteria for posterior glass ionomer restorations

Secondary Outcome Measures

Name	Time	Method
Clinical Performance of restoration and restored tooth	3 years	Clinical performance based on criteria for posterior glass ionomer restorations
Additional Collection of Adverse Events Data	3 years	Data collection of adverse events

Trial Locations

Locations (1)

Lousiana State University Health Science Center, School of Dentistry; 🇺🇸 New Orleans, Louisiana, United States