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

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketac Universal
Ketac Molar Quick
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring dental caries, proximal surfaces, posterior teeth, carious lesions, tooth diseases, dental restorations, glass-ionomer

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lousiana State University Health Science Center, School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ketac Universal

Ketac Molar Quick

Arm Description

Simplified glass ionomer tooth filling

Glass ionomer tooth filling

Outcomes

Primary Outcome Measures

Restoration survival
Survival based on criteria for posterior glass ionomer restorations

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2016
Last Updated
July 23, 2021
Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
3M Oral Care
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1. Study Identification

Unique Protocol Identification Number
NCT02705729
Brief Title
Clinical Performance of Posterior Glass Ionomer Restorations in Adolescents (KETAC)
Official Title
Clinical Performance of a Newly Developed Glass Ionomer Restorative Material for Posterior Restorations in an Adolescent Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 3, 2016 (undefined)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
3M Oral Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, proximal surfaces, posterior teeth, carious lesions, tooth diseases, dental restorations, glass-ionomer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketac Universal
Arm Type
Active Comparator
Arm Description
Simplified glass ionomer tooth filling
Arm Title
Ketac Molar Quick
Arm Type
Active Comparator
Arm Description
Glass ionomer tooth filling
Intervention Type
Device
Intervention Name(s)
Ketac Universal
Other Intervention Name(s)
Ketac Universal Aplicap Glass Ionomer Restorative
Intervention Description
High-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step.
Intervention Type
Device
Intervention Name(s)
Ketac Molar Quick
Other Intervention Name(s)
Ketac Molar Quick Aplicap Glass Ionomer Restorative
Intervention Description
High-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step.
Primary Outcome Measure Information:
Title
Restoration survival
Description
Survival based on criteria for posterior glass ionomer restorations
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Clinical Performance of restoration and restored tooth
Description
Clinical performance based on criteria for posterior glass ionomer restorations
Time Frame
3 years
Title
Additional Collection of Adverse Events Data
Description
Data collection of adverse events
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilde C Peters, DMD, PhD
Organizational Affiliation
LSUHSC School of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Lousiana State University Health Science Center, School of Dentistry
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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