Clinical Performance of Posterior Glass Ionomer Restorations in Adolescents (KETAC)
Clinical Performance of a Newly Developed Glass Ionomer Restorative Material for Posterior Restorations in an Adolescent Population
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedStudy Start
First participant enrolled
August 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedJuly 27, 2021
July 1, 2021
4.7 years
March 7, 2016
July 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Restoration survival
Survival based on criteria for posterior glass ionomer restorations
3 years
Secondary Outcomes (2)
Clinical Performance of restoration and restored tooth
3 years
Additional Collection of Adverse Events Data
3 years
Study Arms (2)
Ketac Universal
ACTIVE COMPARATORSimplified glass ionomer tooth filling
Ketac Molar Quick
ACTIVE COMPARATORGlass ionomer tooth filling
Interventions
High-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step.
High-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnant or breast feeding
- erosion/eating disorders
- bruxism/traumatic malocclusion
- pulpitis
- cusp replacement
- radiographic bone loss/increased tooth mobility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lousiana State University Health Science Center, School of Dentistry
New Orleans, Louisiana, 70119, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mathilde C Peters, DMD, PhD
LSUHSC School of Dentistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor and Postgraduate Program Director
Study Record Dates
First Submitted
March 7, 2016
First Posted
March 10, 2016
Study Start
August 3, 2016
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
July 27, 2021
Record last verified: 2021-07