Dental CariesROCKNCT01523613
High-strength Glass-ionomer Dental Restorations
A study testing Chemfil ROCK Glassionomer restoration and Fuji IX GP Extra Glassionomer restoration in people with Dental Caries, run by Mathilde Peters, DMD, PhD at 1 site in United States.
Trial summary
The purpose of this study is to extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Chemfil ROCK Glassionomer restoration and Fuji IX GP Extra Glassionomer restoration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7-16 year old
- in need of one or two approximal fillings in molars
Who cannot join
- known allergies to calcium-aluminum-zinc-fluoro-phosphor-silicate glass or any other of glassionomer components
Trial locations and contacts
1 site in 1 country.
United States1 site
Mott Childrens' Health Center
Flint, Michigan, 48503
About this study
Official title: Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions
The purpose of this study is to extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials.
The investigators hypothesize that after two years (1) the clinical performance of both filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar or higher incidence of fracture than Fuji IX GP fillings.
Read the detailed description
In this longitudinal prospective randomized control clinical trial, posterior restorations (Class II) will be placed and evaluated for their clinical performance. The study will compare two restorative systems currently on the market in USA: both high-strength glass-ionomer (GI) restorative materials. The study restorations will be monitored for a period of up to 2 years.
- Conditions
- Dental Caries
- Being tested
- Chemfil ROCK Glassionomer restoration, Fuji IX GP Extra Glassionomer restoration
- 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.
Chemfil ROCK Glassionomer restorationDevice
Also called HVGIC, HV-GIC, ART materials
High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
Fuji IX GP Extra Glassionomer restorationDevice
Also called Fuji Equia, HVGIC, HV-GIC, ART materials
High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
| Study group | Role | What they receive |
|---|---|---|
| ROCK - Single Restorations | Active comparator | ChemFil Rock glassionomer restoration Receives: Device: Chemfil ROCK Glassionomer restoration |
| Fuji IX GP - Single Restorations | Active comparator | Fuji IX GP Extra glassionomer restoration Receives: Device: Fuji IX GP Extra Glassionomer restoration |
| Rock AND Fuji - Paired Restorations | Active comparator | ChemFil Rock glassionomer restoration AND Fuji IX GP Extra glassionomer restoration.
While this is not truly a separate arm for outcome analysis, this "arm" represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restoration and 1 Fuji IX GP restoration. Receives: Device: Chemfil ROCK Glassionomer restoration; Device: Fuji IX GP Extra Glassionomer restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate
- Cut-off: Restoration failure as determined by (need for) replacement due to fracture and retention losses within both arms.
- "Clinically successful" is defined as: no need for replacement due to fracture or retention losses.
Measured: 2 years
Secondary outcomes (2)
Caries Incidence Associated With Restoration
- "Caries free restorations" is defined as: free of caries associated with restoration.
Measured: 2 years
Restored Tooth Performance
- Cut-off: Restored tooth failure (tooth in need of repair or management) as determined by Tooth integrity (enamel/tooth fracture), Sensitivity and Vitality assessment within both arms.
- "Clinically successful" is defined as: No need for repair or management due to sensitivity or loss of tooth integrity or vitality.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathilde Peters, DMD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Mott Children's Health Center, Dentsply International
- Responsible party
- Sponsor-investigator, Mathilde Peters, DMD, PhD, University of Michigan
- Investigators
- Mathilde C Peters, DMD, PhD, Study director, U Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523613
- Sponsor's protocol ID
- N013822
- Other IDs
- 11-PAF05343
- Acronym
- ROCK
- Status last verified
- Sep 2017
- First submitted
- 27 Jan 2012
- Last updated
- 3 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions
- ClinicalTrials.gov ID
- NCT01523613
- Acronym / sponsor ID
- ROCK / N013822
- 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
- 93 participants (actual)
- Lead sponsor
- Mathilde Peters, DMD, PhDUniversity, hospital or other
- Collaborators
- Mott Children's Health Center, Dentsply International
- Study start
- Nov 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 3 Oct 2017
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 extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials.
The investigators hypothesize that after two years (1) the clinical performance of both filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar or higher incidence of fracture than Fuji IX GP fillings.
Detailed description
In this longitudinal prospective randomized control clinical trial, posterior restorations (Class II) will be placed and evaluated for their clinical performance. The study will compare two restorative systems currently on the market in USA: both high-strength glass-ionomer (GI) restorative materials. The study restorations will be monitored for a period of up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ROCK - Single Restorations | Active comparator | Device: Chemfil ROCK Glassionomer restorationChemFil Rock glassionomer restoration |
| Fuji IX GP - Single Restorations | Active comparator | Device: Fuji IX GP Extra Glassionomer restorationFuji IX GP Extra glassionomer restoration |
| Rock AND Fuji - Paired Restorations | Active comparator | Device: Chemfil ROCK Glassionomer restoration, Device: Fuji IX GP Extra Glassionomer restorationChemFil Rock glassionomer restoration AND Fuji IX GP Extra glassionomer restoration. While this is not truly a separate arm for outcome analysis, this "arm" represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restoration and 1 Fuji IX GP restoration. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 7-16 year old
- in need of one or two approximal fillings in molars
Key exclusion criteria (1 listed)
- known allergies to calcium-aluminum-zinc-fluoro-phosphor-silicate glass or any other of glassionomer components
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 |
|---|---|---|
| Chemfil ROCK Glassionomer restorationAlso: HVGIC, HV-GIC, ART materialsHigh-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material. | Device | ROCK - Single Restorations, Rock AND Fuji - Paired Restorations |
| Fuji IX GP Extra Glassionomer restorationAlso: Fuji Equia, HVGIC, HV-GIC, ART materialsHigh-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material. | Device | Fuji IX GP - Single Restorations, Rock AND Fuji - Paired Restorations |
Primary outcome
Survival Rate
Time frame: 2 years
* Cut-off: Restoration failure as determined by (need for) replacement due to fracture and retention losses within both arms. * "Clinically successful" is defined as: no need for replacement due to fracture or retention losses.
2 secondary outcomes
Caries Incidence Associated With Restoration
Time frame: 2 years
Restored Tooth Performance
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
U Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemfil ROCK Glassionomer restoration and Fuji IX GP Extra Glassionomer restoration in people with Dental Caries, run by Mathilde Peters, DMD, PhD 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 2 inclusion and 1 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 3 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival Rate (time frame: 2 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 3 Oct 2017.