Tooth DiseaseNCT04685954
Clinical Comparison of Bulk-fill and Incremental Composite
A study testing Filtek Bulk-Fill Posterior and Filtek Ultimate Universal in people with Tooth Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Disease
- What is being tested?
- Filtek Bulk-Fill Posterior and Filtek Ultimate Universal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Jun 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age range will be 18 to 65
- patients should have at least 2 approximal caries lesions require restoration
- healthy periodontal status
- a good likelihood of recall availability
Who cannot join
- poor gingival health
- adverse medical history
- potential behavioral problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison of Bulk-fill and Incremental Composite Resin Restorations
The clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a 5 mm bulk-fill composite resin [Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)] and an incremental posterior composite resin [Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.
- Conditions
- Tooth Disease
- Being tested
- Filtek Bulk-Fill Posterior, Filtek Ultimate Universal
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtek Bulk-Fill PosteriorDevice
Bulk-fill restorative composite
Filtek Ultimate UniversalDevice
Incremental restorative composite
| Study group | Role | What they receive |
|---|---|---|
| Bulk-Fill | Experimental | Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB) Receives: Device: Filtek Bulk-Fill Posterior |
| Incremental | Experimental | Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU) Receives: Device: Filtek Ultimate Universal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performances of different restorative systems according to USPHS criteria
Two year results according to USPHS criteria
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Mar 2018
- Primary completion1 Jun 2018
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fatma Dilşad Öz, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685954
- Sponsor's protocol ID
- bulk-incremental
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Bulk-fill and Incremental Composite Resin Restorations
- ClinicalTrials.gov ID
- NCT04685954
- Acronym / sponsor ID
- bulk-incremental
- Conditions
- Tooth Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 28 Dec 2020 (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 clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a 5 mm bulk-fill composite resin [Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)] and an incremental posterior composite resin [Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bulk-Fill | Experimental | Device: Filtek Bulk-Fill PosteriorFiltek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB) |
| Incremental | Experimental | Device: Filtek Ultimate UniversalFiltek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age range will be 18 to 65
- patients should have at least 2 approximal caries lesions require restoration
- healthy periodontal status
- a good likelihood of recall availability
Key exclusion criteria (3 listed)
- poor gingival health
- adverse medical history
- potential behavioral problems
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 Bulk-Fill PosteriorBulk-fill restorative composite | Device | Bulk-Fill |
| Filtek Ultimate UniversalIncremental restorative composite | Device | Incremental |
Primary outcome
Clinical performances of different restorative systems according to USPHS criteria
Time frame: two years
Two year results according to USPHS criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bulk-Fill Posterior and Filtek Ultimate Universal in people with Tooth Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Clinical performances of different restorative systems according to USPHS criteria (time frame: two 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 17 Feb 2021.