Dental CariesNCT03527953
A 24-month Clinical Evaluation of Different Bulk-fill Restorative Resins in Class II Restorations
A study testing Tetric EvoCeram Bulkfill, Surefil SDR Flowable bulkfill and everX fiber-reinforced resin in people with Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the clinical performance of three different bulk-fill restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin composite and a fiber-reinforced resin in Class II restorations over a period of 24 months. Read more about this study
- Who is it for?
- Ages 20 to 41 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Tetric EvoCeram Bulkfill, Surefil SDR Flowable bulkfill and everX fiber-reinforced resin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2013to Jan 2016
- 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 20 to 41 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who accept to participate and sign the informed consent
- Patients who have at least three similar-sized approximal primary caries lesions in premolar and molar teeth.
- The teeth to be restored had a normal occlusal relationship with natural dentition and had adjacent tooth contact and had a normal response to a vitality test with no periapical pathology
Who cannot join
- Patients who don't accept to participate and sign the informed consent
- Patients who have a history of adverse reaction to the test materials
- Patients who are pregnant or lactating, have fewer than 20 teeth
- Patients who have poor oral hygiene, have severe or chronic periodontal disease, have heavy bruxism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Different Bulk-fill Restorative Resin Restorations
The aim of this study is to evaluate the clinical performance of three different bulk-fill restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin composite and a fiber-reinforced resin in Class II restorations over a period of 24 months.
Read the detailed description
The objective of this study is to evaluate the 24-month clinical performance of three different bulk-fill restorative resin materials in Class II restorations. Forty patients with at least three approximal lesions in premolar and molar teeth will be participated in the study. A total of 120 Class II cavities will be restored using Tetric EvoCeram Bulk Fill (n=40), SureFil SDR flow + Ceram X mono (n=40), and everX Posterior + G-aenial Posterior (n=40) with their respective adhesives according to the manufacturers' instructions. All restorations will be placed by one operator. The restorations will be evaluated at baseline and at 6, 12, 18, and 24 months using modified USPHS criteria by one examiner. The restoration groups for each category will be compared using Pearson's chi-square test, while Cochran's Q test will be used to compare the changes across different time points within each restorative material (p<0.05).
- Conditions
- Dental Caries
- Being tested
- Tetric EvoCeram Bulkfill, Surefil SDR Flowable bulkfill, everX fiber-reinforced resin
- Keywords
- bulk-fill restorative resins, dental caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetric EvoCeram BulkfillOther
The preparation will be etched with 37% phosphoric acid. It will be then rinsed with an air-water spray and dried, leaving the dentin slightly moist. An etch-and-rinse adhesive, ExciTE F, will be applied and agitated on the prepared surfaces for at least 10 seconds. The adhesive will be air-thinned and light-cured for 20 seconds with an LED curing unit. The sectional matrix will be placed and fixed with wooden wedges. Then the bulk-fill resin composite, TBF, will be placed in bulk in about 4-mm thickness and then will be cured for 20 seconds.
Surefil SDR Flowable bulkfillOther
The preparation will be etched. A two-step etch-and-rinse adhesive, Prime\&Bond NT will be applied to all enamel/dentin surfaces, air-dried for 5 seconds, and will be light cured for 10 seconds. After the sectional matrix will be placed, the flowable bulk-fill resin composite, SureFil SDR™ flow (Dentsply Caulk, Milford, DE, USA), will be placed in a 4-mm bulk increment in the dentinal part cured for 20 seconds and will be followed by a covering layer of the nanohybrid resin composite, Ceram.X Mono that will be cured for 20 seconds.
everX fiber-reinforced resinOther
The enamel will be etched with 37% phosphoric acid for 10 seconds, then will be rinsed, and dried with an air/water syringe for at least 5 seconds. Self-etch adhesive, G-aenial Bond (GC Co., Tokyo, Japan), will be applied to all enamel/dentin surfaces and gently air thinned and then will be light cured for 10 seconds. After the matrix will be placed and wedged, mesial or distal walls will be built with 1-2-mm layers of G-aenial Posterior resin composite. The fiber-reinforced composite, everX Posterior, will be placed into the cavity in approximately 4-mm thickness. The last 2 mm of the cavity will be restored using the G-aenial Posterior composite as an overlay layer. Each increment will be light cured for 20 seconds using an LED unit.
| Study group | Role | What they receive |
|---|---|---|
| Tetric EvoCeram BulkFill resin | Active comparator | Randomly applied Receives: Other: Tetric EvoCeram Bulkfill |
| Surefil SDR Flowable bulk-fill resin | Active comparator | Randomly applied Receives: Other: Surefil SDR Flowable bulkfill |
| everX fiber-reinforced resin | Active comparator | Randomly applied Receives: Other: everX fiber-reinforced resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria
Long-term clinical success of different restorative resins in class II cavities on posterior teeth
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 posted17 May 2018
- Study startNov 2013
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A Ruya Yazici, Hacettepe University
- Investigators
- A.Ruya Yazici, DDS, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527953
- Sponsor's protocol ID
- 71146310
- Status last verified
- May 2018
- First submitted
- 5 May 2018
- Last updated
- 17 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yazici AR, Antonson SA, Kutuk ZB, Ergin E. Thirty-Six-Month Clinical Comparison of Bulk Fill and Nanofill Composite Restorations. Oper Dent. 2017 Sep/Oct;42(5):478-485. doi: 10.2341/16-220-C. Epub 2017 Jun 5.
PubMed 28581919
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Bulk-fill Restorative Resin Restorations
- ClinicalTrials.gov ID
- NCT03527953
- Acronym / sponsor ID
- 71146310
- Conditions
- Dental Caries
- Keywords
- bulk-fill restorative resins, dental caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 May 2018 (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 aim of this study is to evaluate the clinical performance of three different bulk-fill restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin composite and a fiber-reinforced resin in Class II restorations over a period of 24 months.
Detailed description
The objective of this study is to evaluate the 24-month clinical performance of three different bulk-fill restorative resin materials in Class II restorations. Forty patients with at least three approximal lesions in premolar and molar teeth will be participated in the study. A total of 120 Class II cavities will be restored using Tetric EvoCeram Bulk Fill (n=40), SureFil SDR flow + Ceram X mono (n=40), and everX Posterior + G-aenial Posterior (n=40) with their respective adhesives according to the manufacturers' instructions. All restorations will be placed by one operator. The restorations will be evaluated at baseline and at 6, 12, 18, and 24 months using modified USPHS criteria by one examiner. The restoration groups for each category will be compared using Pearson's chi-square test, while Cochran's Q test will be 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
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tetric EvoCeram BulkFill resin | Active comparator | Other: Tetric EvoCeram BulkfillRandomly applied |
| Surefil SDR Flowable bulk-fill resin | Active comparator | Other: Surefil SDR Flowable bulkfillRandomly applied |
| everX fiber-reinforced resin | Active comparator | Other: everX fiber-reinforced resinRandomly applied |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who accept to participate and sign the informed consent
- Patients who have at least three similar-sized approximal primary caries lesions in premolar and molar teeth.
- The teeth to be restored had a normal occlusal relationship with natural dentition and had adjacent tooth contact and had a normal response to a vitality test with no periapical pathology
Key exclusion criteria (4 listed)
- Patients who don't accept to participate and sign the informed consent
- Patients who have a history of adverse reaction to the test materials
- Patients who are pregnant or lactating, have fewer than 20 teeth
- Patients who have poor oral hygiene, have severe or chronic periodontal disease, have heavy bruxism
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 |
|---|---|---|
| Tetric EvoCeram BulkfillThe preparation will be etched with 37% phosphoric acid. It will be then rinsed with an air-water spray and dried, leaving the dentin slightly moist. An etch-and-rinse adhesive, ExciTE F, will be applied and agitated on the prepared surfaces for at least 10 seconds. The adhesive will be air-thinned and light-cured for 20 seconds with an LED curing unit. The sectional matrix will be placed and fixed with wooden wedges. Then the bulk-fill resin composite, TBF, will be placed in bulk in about 4-mm thickness and then will be cured for 20 seconds. | Other | Tetric EvoCeram BulkFill resin |
| Surefil SDR Flowable bulkfillThe preparation will be etched. A two-step etch-and-rinse adhesive, Prime\&Bond NT will be applied to all enamel/dentin surfaces, air-dried for 5 seconds, and will be light cured for 10 seconds. After the sectional matrix will be placed, the flowable bulk-fill resin composite, SureFil SDR™ flow (Dentsply Caulk, Milford, DE, USA), will be placed in a 4-mm bulk increment in the dentinal part cured for 20 seconds and will be followed by a covering layer of the nanohybrid resin composite, Ceram.X Mono that will be cured for 20 seconds. | Other | Surefil SDR Flowable bulk-fill resin |
| everX fiber-reinforced resinThe enamel will be etched with 37% phosphoric acid for 10 seconds, then will be rinsed, and dried with an air/water syringe for at least 5 seconds. Self-etch adhesive, G-aenial Bond (GC Co., Tokyo, Japan), will be applied to all enamel/dentin surfaces and gently air thinned and then will be light cured for 10 seconds. After the matrix will be placed and wedged, mesial or distal walls will be built with 1-2-mm layers of G-aenial Posterior resin composite. The fiber-reinforced composite, everX Posterior, will be placed into the cavity in approximately 4-mm thickness. The last 2 mm of the cavity will be restored using the G-aenial Posterior composite as an overlay layer. Each increment will be light cured for 20 seconds using an LED unit. | Other | everX fiber-reinforced resin |
Primary outcome
Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria
Time frame: 2 years
Long-term clinical success of different restorative resins in class II cavities on posterior 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 17 May 2018.
- Results publication: PubMed 28581919Yazici AR, Antonson SA, Kutuk ZB, Ergin E. Thirty-Six-Month Clinical Comparison of Bulk Fill and Nanofill Composite Restorations. Oper Dent. 2017 Sep/Oct;42(5):478-485. doi: 10.2341/16-220-C. Epub 2017 Jun 5.
- PubMedLink provided by the sponsor.
- 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.
A.Ruya Yazici, DDS, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetric EvoCeram Bulkfill, Surefil SDR Flowable bulkfill and everX fiber-reinforced resin in people with Dental Caries, 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 3 inclusion and 4 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 17 May 2018. 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?
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 evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527953, which also lists 1 linked publication.
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 May 2018.