Dental CariesNCT03175627
Clinical Performance of Posterior Composite Tooth Fillings in Adults
A study testing Filtek One and Filtek Z250 in people with Dental Caries and Dental Restoration Failure, 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 a new tooth-colored composite material is effective for load-bearing dental fillings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries, Dental Restoration Failure
- What is being tested?
- Filtek One and Filtek Z250
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 31 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be older than 18 years of age
- have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings
- both study teeth must be vital (tested with cold)
- both study fillings must be visible on the cheek-side of the tooth.
Who cannot join
- do not meet all inclusion criteria
- are under active orthodontic treatment
- have severe medical complications
- have dry mouth
- have chronic gum disease or poor oral hygiene
- are unavailable for long term recall (minimum of 2 years required)
Show all 10Show fewer
- cannot tolerate the rubber dam
- have an unstable tooth contacts
- have severe bruxing or clenching, or are in need of jaw joint therapy
- are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lousiana State University Health Science Center, School of DentistrySchool of Dentistry
New Orleans, Louisiana, 70119
About this study
Official title: Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects
The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.
Read the detailed description
In this post-market prospective randomized controlled clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. The bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.
- Conditions
- Dental Caries, Dental Restoration Failure
- Being tested
- Filtek One, Filtek Z250
- Keywords
- Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Composite resin
- 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.
Filtek OneDevice
Also called 3M™ Filtek™ One Bulk Fill Restorative
Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.
Filtek Z250Device
Also called 3M™ Filtek™ Z250 Universal Restorative
Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.
| Study group | Role | What they receive |
|---|---|---|
| Filtek One | Active comparator | Bulk fill composite material used for posterior tooth fillings. Receives: Device: Filtek One |
| Filtek Z250 | Active comparator | Composite material used for incremental filling of posterior teeth. Receives: Device: Filtek Z250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with restoration failure of either material
Restoration failure is based on clinical performance criteria according to the Fédération Dentaire Internationale (FDI) rating system. An assessment of score 5, indicating poor performance, in any of the three categories esthetic, functional or biological performance will be considered a failure.
Measured: 2 years
Secondary outcomes (2)
Clinical performance score for each restoration
Quality rating for each restoration/material based on the FDI clinical performance scores (1-5) for the three categories esthetic, functional and biological performance.
Measured: 2 years
Confirmation of material safety
Number of participants with unanticipated treatment-related Adverse Events as assessed by • Fatal, • Persistent disability or significant incapacity, • Congenital anomaly/birth defect or cancer, • Life-Threatening, • Associated with overdose, • Required hospital admission or prolongation of hospitalization (Adverse Events Reporting Requirements LSUHSC-NO IRB).
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 posted5 Jun 2017
- Study start10 May 2017
- Primary completion31 May 2021
- Study completion31 May 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
- Model description
- In a split-mouth design, each participant will receive 2 matched restorations, one of each material.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, Adriana Cordero Wilson, 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
- NCT03175627
- Sponsor's protocol ID
- 11-050008
- Status last verified
- Jun 2021
- First submitted
- 31 May 2017
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects
- ClinicalTrials.gov ID
- NCT03175627
- Acronym / sponsor ID
- 11-050008
- Conditions
- Dental Caries, Dental Restoration Failure
- Keywords
- Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Composite resin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 10 May 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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 a new tooth-colored composite material is effective for load-bearing dental fillings.
Detailed description
In this post-market prospective randomized controlled clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. The bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In a split-mouth design, each participant will receive 2 matched restorations, one of each material.
| Arm | Type | Receives |
|---|---|---|
| Filtek One | Active comparator | Device: Filtek OneBulk fill composite material used for posterior tooth fillings. |
| Filtek Z250 | Active comparator | Device: Filtek Z250Composite material used for incremental filling of posterior teeth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be older than 18 years of age
- have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings
- both study teeth must be vital (tested with cold)
- both study fillings must be visible on the cheek-side of the tooth.
Key exclusion criteria (10 listed)
- do not meet all inclusion criteria
- are under active orthodontic treatment
- have severe medical complications
- have dry mouth
- have chronic gum disease or poor oral hygiene
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 |
|---|---|---|
| Filtek OneAlso: 3M™ Filtek™ One Bulk Fill RestorativeRestoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique. | Device | Filtek One |
| Filtek Z250Also: 3M™ Filtek™ Z250 Universal RestorativeRestoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique. | Device | Filtek Z250 |
Primary outcome
Number of participants with restoration failure of either material
Time frame: 2 years
Restoration failure is based on clinical performance criteria according to the Fédération Dentaire Internationale (FDI) rating system. An assessment of score 5, indicating poor performance, in any of the three categories esthetic, functional or biological performance will be considered a failure.
2 secondary outcomes
Clinical performance score for each restoration
Time frame: 2 years
Confirmation of material safety
Time frame: 2 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 28 Jun 2021.
- Individual participant dataSharing planned: No
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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 Filtek One and Filtek Z250 in people with Dental Caries and Dental Restoration Failure, 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 4 inclusion and 10 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 28 Jun 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?
Number of participants with restoration failure of either material (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 28 Jun 2021.