Dental Restoration Failure of Marginal IntegrityClinicalNCT04306549
Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
A study testing Bulk-Fill and Microhybrid Composite Resins in people with Dental Restoration Failure of Marginal Integrity, run by Tokat Gaziosmanpasa University.
Trial summary
ABSTRACT Objective The aim of this study was to evaluate the clinical performance of one microhybrid and two bulk-fill resin composites in Class II cavities for up to two years. Materials and methods In total, 75 Class II restorations were made in 25 patients, using three restorative materials: two nanohybrid… Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Bulk-Fill and Microhybrid Composite Resins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2016to 4 Jan 2019
- 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 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient in need of restoration of caries lesion (diagnosed with bitewing radiograph and clinical examination);
- teeth in need of restoration to be first or second molars or permanent premolars;
- at least three Class II restorations required in each patient and the number of restorations of each material to be equal in each patient;
- the antagonist and adjacent tooth in contact;
- pulp vitalized and free of painful symptoms; teeth involved not to have undergone direct pulp capping;
- no history of hypersensitivity in the teeth to be restored;
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- permanent dentition;
- good oral health and absence of periodontal disease;
- patients not to have suffered from systemic diseases or allergies;
- absence of deleterious habits, xerostomia, and bruxism.
Who cannot join
- Fewer than 20 teeth;
- history of existing tooth sensitivity;
- known allergy to resin-based materials or any of the other materials used in this study;
- pregnancy or breastfeeding;
- chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs;
- non-vital teeth;
- abutment teeth for fixed or removable prostheses.
About this study
ABSTRACT Objective The aim of this study was to evaluate the clinical performance of one microhybrid and two bulk-fill resin composites in Class II cavities for up to two years.
Materials and methods In total, 75 Class II restorations were made in 25 patients, using three restorative materials: two nanohybrid bulk-fill resin composites, Sonic Fill (SF) and x-tra fil (XF), and a microhybrid composite, Filtek Z-250 (FZ). The restorations were blindly evaluated by two examiners at baseline and at 6, 12, and 24 months, using U.S. Public Health Service (USPHS) criteria. The restoration groups for each category were compared using the Pearson chi-square test, and the Cochran Q-test was used to compare the changes across different time points within each restorative material (p <0.05).
- Being tested
- Bulk-Fill and Microhybrid Composite Resins
- Keywords
- Clinical study, USPHS criteria, bulk-fill, resin composite, Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk-Fill and Microhybrid Composite ResinsOther
Also called Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
Clinical Comparison of Composite Restorations (Two Bulk-Fill and one Microhybrid Composite Resin) to the USPHS Criterias
| Study group | Role | What they receive |
|---|---|---|
| Bulk-fill resin composite-sonic activated | Experimental | 5 mm bulk-filling without capping lightcured 40s Receives: Other: Bulk-Fill and Microhybrid Composite Resins |
| Bulk-fill resin composite | Experimental | 4 mm bulk-filling without capping lightcured 10s Receives: Other: Bulk-Fill and Microhybrid Composite Resins |
| Microhybrid resin composite | Experimental | 2 mm layers, lightcured 20s Receives: Other: Bulk-Fill and Microhybrid Composite Resins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Acceptability
One week after restoration placement (baseline), patients were recalled and restorations were examined clinically. Direct clinical evaluation of restorations was performed using the USPHS criteria by two independent investigators using mirrors, probes, and bitewing radiographs and scored as Alpha, Bravo, or Charlie. Alpha corresponded to excellent, Bravo to clinically acceptable, and Charlie to clinically unacceptable results. Patients were recalled at 6, 12, and 24 months for assessments of the restorations, using the same criteria as at baseline. At each recall, the same two calibrated evaluators, who were blinded to the restoratives used for cavities and patients, examined the restorations. To ensure a double-blind study, the evaluators were not informed about which filling material had been used on which teeth.
Measured: Twenty-Four-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start3 Aug 2016
- Primary completion3 Jan 2017
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration Failure of Marginal IntegrityStudies 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Beykent, Çanakkale Onsekiz Mart University
- Responsible party
- Principal investigator, Emine Sirin Karaarslan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306549
- Sponsor's protocol ID
- 2015/36
- Acronym
- Clinical
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
- ClinicalTrials.gov ID
- NCT04306549
- Acronym / sponsor ID
- Clinical / 2015/36
- Keywords
- Clinical study, USPHS criteria, bulk-fill, resin composite, Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Collaborators
- University of Beykent, Çanakkale Onsekiz Mart University
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 13 Mar 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.
ABSTRACT Objective The aim of this study was to evaluate the clinical performance of one microhybrid and two bulk-fill resin composites in Class II cavities for up to two years.
Materials and methods In total, 75 Class II restorations were made in 25 patients, using three restorative materials: two nanohybrid bulk-fill resin composites, Sonic Fill (SF) and x-tra fil (XF), and a microhybrid composite, Filtek Z-250 (FZ). The restorations were blindly evaluated by two examiners at baseline and at 6, 12, and 24 months, using U.S. Public Health Service (USPHS) criteria. The restoration groups for each category were compared using the Pearson chi-square test, and the Cochran Q-test was used to compare the changes across different time points within each restorative material (p <0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bulk-fill resin composite-sonic activated | Experimental | Other: Bulk-Fill and Microhybrid Composite Resins5 mm bulk-filling without capping lightcured 40s |
| Bulk-fill resin composite | Experimental | Other: Bulk-Fill and Microhybrid Composite Resins4 mm bulk-filling without capping lightcured 10s |
| Microhybrid resin composite | Experimental | Other: Bulk-Fill and Microhybrid Composite Resins2 mm layers, lightcured 20s |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patient in need of restoration of caries lesion (diagnosed with bitewing radiograph and clinical examination);
- teeth in need of restoration to be first or second molars or permanent premolars;
- at least three Class II restorations required in each patient and the number of restorations of each material to be equal in each patient;
- the antagonist and adjacent tooth in contact;
- pulp vitalized and free of painful symptoms; teeth involved not to have undergone direct pulp capping;
Key exclusion criteria (7 listed)
- Fewer than 20 teeth;
- history of existing tooth sensitivity;
- known allergy to resin-based materials or any of the other materials used in this study;
- pregnancy or breastfeeding;
- chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs;
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 |
|---|---|---|
| Bulk-Fill and Microhybrid Composite ResinsAlso: Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite RestorationsClinical Comparison of Composite Restorations (Two Bulk-Fill and one Microhybrid Composite Resin) to the USPHS Criterias | Other | Bulk-fill resin composite, Bulk-fill resin composite-sonic activated, Microhybrid resin composite |
Primary outcome
Clinical Acceptability
Time frame: Twenty-Four-Month
One week after restoration placement (baseline), patients were recalled and restorations were examined clinically. Direct clinical evaluation of restorations was performed using the USPHS criteria by two independent investigators using mirrors, probes, and bitewing radiographs and scored as Alpha, Bravo, or Charlie. Alpha corresponded to excellent, Bravo to clinically acceptable, and Charlie to clinically unacceptable results. Patients were recalled at 6, 12, and 24 months for assessments of the restorations, using the same criteria as at baseline. At each recall, the same two calibrated evaluators, who were blinded to the restoratives used for cavities and patients, examined the restorations. To ensure a double-blind study, the evaluators were not informed about which filling material had been used on which teeth.
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 13 Mar 2020.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Bulk-Fill and Microhybrid Composite Resins in people with Dental Restoration Failure of Marginal Integrity, run by Tokat Gaziosmanpasa University.
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 10 inclusion and 7 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 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Acceptability (time frame: Twenty-Four-Month). 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 13 Mar 2020.