Post Dental RestorationNCT03230604
Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations
A study testing Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite and Z 350 Xt Composite in people with Post Dental Restoration and Caries, Dental, run by Universidad Nacional Andres Bello at 1 site in Chile.
Trial summary
To minimize the effects of polymerization shrinkage in the restorative treatment, there are new composites called Bulk- Fill which the companies has developed this composites for example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Dental Restoration, Caries, Dental
- What is being tested?
- Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite and Z 350 Xt Composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChile
- Study dates
- 1 Apr 2016to 1 Dec 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- must have given written informed consent to participate in the trial
- need at least three posterior restorations
- must be available for the required post-operative follow-up visits
- have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
- At least one occlusal and proximal contact on a natural tooth
- Cavities depth > 2 mm in cervico-occlusal
Who cannot join
- have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations
- have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
- chronic periodontitis
- present with any systemic or local disorders that contra-indicate the dental procedures included in this study
- an unstable occlusion
- severe bruxing
Show all 9Show fewer
- teeth with periapical pathology or expected pulp exposures
- are pregnant.
- Endodontically treated teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Bulk-fill Resins Composite Restorations on Posterior Tooth of Adults Patients. Randomized Doble-blind Trial
To minimize the effects of polymerization shrinkage in the restorative treatment, there are new composites called Bulk- Fill which the companies has developed this composites for example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization shrinkage and properties allow the material to be inserted in one layer being quickly than traditional composite. This clinical study is designed to compare the clinical performance of the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior) and V (cervical-surface posterior) fillings.
Read the detailed description
A patients with 3 caries lesions class one either two or five will be divided into 3 groups , cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (Bluephase Style Ivoclar-Vivadent), with an energy 1,100 mW/cm² (±50 mw/cm²) and others group of cavities will be restored by bulk fill composite (3M ESPE) and other bulk fill composite ( IVOCLAR-VIVADENT) as one increment then will be cured as directed by the manufacturer with the light curing unit.
The study will investigate the clinical performance and efficacy of a bulk-filled composite resin restorative material for a period of 5 years
- Conditions
- Post Dental Restoration, Caries, Dental
- Being tested
- Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite, Z 350 Xt Composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill CompositeDevice
Restorative cavities one, two and five with material Filtek Bulk Fill Composite
Z 350 Xt CompositeDevice
Restorative cavities one, two and five with material Z 350 XT Composite
| Study group | Role | What they receive |
|---|---|---|
| Bulk-Fill composite Class I, II and V cavities | Active comparator | Restorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V Receives: Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite; Device: Z 350 Xt Composite |
| Z 350 xt Composite | Active comparator | Restorative with Z 350 xt composite in class I, II and V Receives: Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite; Device: Z 350 Xt Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance restoration
Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI criteria , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor.
Measured: six month, one years, two, three, four and five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Apr 2016
- Primary completion24 Jul 2017
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Dental RestorationStudies 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
- Intervention: Bulk full composite (3M) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities Intervention:Bulk full composite (Ivoclar-Vivadent) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities Other: bulk fill composite Intervention Control: Nano resin composite (K Z350 xt) Restoration in class one cavities Restoration in class Two cavities Restoration in class five cavities
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Andres Bello
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricio Vildosola Grez, Universidad Nacional Andres Bello
- Investigators
- Odontologia, Principal investigator, Universidad Nacional Andres Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230604
- Sponsor's protocol ID
- DI-1301-16/CB
- Status last verified
- May 2022
- First submitted
- 24 Jul 2017
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Bulk-fill Resins Composite Restorations on Posterior Tooth of Adults Patients. Randomized Doble-blind Trial
- ClinicalTrials.gov ID
- NCT03230604
- Acronym / sponsor ID
- DI-1301-16/CB
- Conditions
- Post Dental Restoration, Caries, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Universidad Nacional Andres BelloUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 26 Jul 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.
To minimize the effects of polymerization shrinkage in the restorative treatment, there are new composites called Bulk- Fill which the companies has developed this composites for example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization shrinkage and properties allow the material to be inserted in one layer being quickly than traditional composite. This clinical study is designed to compare the clinical performance of the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior) and V (cervical-surface posterior) fillings.
Detailed description
A patients with 3 caries lesions class one either two or five will be divided into 3 groups , cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (Bluephase Style Ivoclar-Vivadent), with an energy 1,100 mW/cm² (±50 mw/cm²) and others group of cavities will be restored by bulk fill composite (3M ESPE) and other bulk fill composite ( IVOCLAR-VIVADENT) as one increment then will be cured as directed by the manufacturer with the light curing unit.
The study will investigate the clinical performance and efficacy of a bulk-filled composite resin restorative material for a period of 5 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention: Bulk full composite (3M) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities Intervention:Bulk full composite (Ivoclar-Vivadent) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities Other: bulk fill composite Intervention Control: Nano resin composite (K Z350 xt) Restoration in class one cavities Restoration in class Two cavities Restoration in class five cavities
| Arm | Type | Receives |
|---|---|---|
| Bulk-Fill composite Class I, II and V cavities | Active comparator | Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite, Device: Z 350 Xt CompositeRestorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V |
| Z 350 xt Composite | Active comparator | Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite, Device: Z 350 Xt CompositeRestorative with Z 350 xt composite in class I, II and V |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- must have given written informed consent to participate in the trial
- need at least three posterior restorations
- must be available for the required post-operative follow-up visits
- have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
- At least one occlusal and proximal contact on a natural tooth
Key exclusion criteria (9 listed)
- have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations
- have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
- chronic periodontitis
- present with any systemic or local disorders that contra-indicate the dental procedures included in this study
- an unstable occlusion
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 Composite and Tetric N Ceram Bulk Fill CompositeRestorative cavities one, two and five with material Filtek Bulk Fill Composite | Device | Bulk-Fill composite Class I, II and V cavities, Z 350 xt Composite |
| Z 350 Xt CompositeRestorative cavities one, two and five with material Z 350 XT Composite | Device | Bulk-Fill composite Class I, II and V cavities, Z 350 xt Composite |
Primary outcome
Clinical performance restoration
Time frame: six month, one years, two, three, four and five years
Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI criteria , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor.
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 18 May 2022.
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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.
Odontologia principal investigator
Universidad Nacional Andres Bello
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 Composite and Tetric N Ceram Bulk Fill Composite and Z 350 Xt Composite in people with Post Dental Restoration and Caries, Dental, run by Universidad Nacional Andres Bello at 1 site in Chile.
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 6 inclusion and 9 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 18 May 2022. 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 Chile. 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?
Clinical performance restoration (time frame: six month, one years, two, three, four and five 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 18 May 2022.