Dental CariesNCT02705729
Clinical Performance of Posterior Glass Ionomer Restorations in Adolescents (KETAC)
A study testing Ketac Universal and Ketac Molar Quick in people with Dental Caries, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Ketac Universal and Ketac Molar Quick
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2016to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- pregnant or breast feeding
- erosion/eating disorders
- bruxism/traumatic malocclusion
- pulpitis
- cusp replacement
- radiographic bone loss/increased tooth mobility
Trial locations and contacts
1 site in 1 country.
United States1 site
Lousiana State University Health Science Center, School of Dentistry
New Orleans, Louisiana, 70119
About this study
Official title: Clinical Performance of a Newly Developed Glass Ionomer Restorative Material for Posterior Restorations in an Adolescent Population
The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Ketac Universal, Ketac Molar Quick
- Keywords
- dental caries, proximal surfaces, posterior teeth, carious lesions, tooth diseases, dental restorations, glass-ionomer
- Medical subject headings
- Dental Caries, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketac UniversalDevice
Also called Ketac Universal Aplicap Glass Ionomer Restorative
High-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step.
Ketac Molar QuickDevice
Also called Ketac Molar Quick Aplicap Glass Ionomer Restorative
High-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step.
| Study group | Role | What they receive |
|---|---|---|
| Ketac Universal | Active comparator | Simplified glass ionomer tooth filling Receives: Device: Ketac Universal |
| Ketac Molar Quick | Active comparator | Glass ionomer tooth filling Receives: Device: Ketac Molar Quick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration survival
Survival based on criteria for posterior glass ionomer restorations
Measured: 3 years
Secondary outcomes (2)
Clinical Performance of restoration and restored tooth
Clinical performance based on criteria for posterior glass ionomer restorations
Measured: 3 years
Additional Collection of Adverse Events Data
Data collection of adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start3 Aug 2016
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- 3M Oral Care
- Responsible party
- Principal investigator, Suzanne E Fournier, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Mathilde C Peters, DMD, PhD, Study director, LSUHSC School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705729
- Sponsor's protocol ID
- LSUHSC-NO #9270
- Status last verified
- Jul 2021
- First submitted
- 7 Mar 2016
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Newly Developed Glass Ionomer Restorative Material for Posterior Restorations in an Adolescent Population
- ClinicalTrials.gov ID
- NCT02705729
- Acronym / sponsor ID
- LSUHSC-NO #9270
- Conditions
- Dental Caries
- Keywords
- dental caries, proximal surfaces, posterior teeth, carious lesions, tooth diseases, dental restorations, glass-ionomer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- 3M Oral Care
- Study start
- 3 Aug 2016
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketac Universal | Active comparator | Device: Ketac UniversalSimplified glass ionomer tooth filling |
| Ketac Molar Quick | Active comparator | Device: Ketac Molar QuickGlass ionomer tooth filling |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- needs 2 Class II posterior restorations
- in good health
- sufficient oral hygiene
- vital tooth
- caries in the outer and/or middle third of dentin
Key exclusion criteria (6 listed)
- pregnant or breast feeding
- erosion/eating disorders
- bruxism/traumatic malocclusion
- pulpitis
- cusp replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketac UniversalAlso: Ketac Universal Aplicap Glass Ionomer RestorativeHigh-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step. | Device | Ketac Universal |
| Ketac Molar QuickAlso: Ketac Molar Quick Aplicap Glass Ionomer RestorativeHigh-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step. | Device | Ketac Molar Quick |
Primary outcome
Restoration survival
Time frame: 3 years
Survival based on criteria for posterior glass ionomer restorations
2 secondary outcomes
Clinical Performance of restoration and restored tooth
Time frame: 3 years
Additional Collection of Adverse Events Data
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathilde C Peters, DMD, PhD study director
LSUHSC School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketac Universal and Ketac Molar Quick in people with Dental Caries, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.