Noncarious Cervical LesionsNCT04261140
Clinical Evaluation of Four Aesthetic Restorations in Non-carious Cervical Lesions
A study testing EQUIA Forte Fil, Clearfil Majesty Esthetic and NexComp Flow in people with Noncarious Cervical Lesions, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare the clinical performance of high-viscosity glass ionomer, flowable composite, bulkfill composite and nanohybrid composite restorations in non-carious cervical lesions (NCCLs). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Noncarious Cervical Lesions
- What is being tested?
- EQUIA Forte Fil, Clearfil Majesty Esthetic and NexComp Flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2019to 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- had at least four non-carious symmetrical cervical lesions,
- had permanent dentition and were older than 20 years old,
- had cervical margins in dentin
Who cannot join
- periodontal disease
- pregnant or breastfeeding
- being under orthodontic therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Dentistry Faculty
Rize, 53000
About this study
Official title: Clinical Evaluation of Four Aesthetic Restorations in Non-carious Cervical Lesions: a Randomised Controlled Split-mouth Clinical Trial
To compare the clinical performance of high-viscosity glass ionomer, flowable composite, bulkfill composite and nanohybrid composite restorations in non-carious cervical lesions (NCCLs).
Read the detailed description
One hundred fourty NCCLs were randomised into four groups according to a split-mouth design. Clinical evaluations will be performed after 1 week, 3 months, 6 months, using FDI (World Dental Federation) criteria.
- Conditions
- Noncarious Cervical Lesions
- Being tested
- EQUIA Forte Fil, Clearfil Majesty Esthetic, NexComp Flow, 3M Espe Bulk-fill
- Keywords
- High-viscosity glass ionomer, bulkfill composite, flowable composite, nanohybrid composite, cervical lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQUIA Forte FilOther
Apply cavity conditioner (20% polyacrylic acid) 10 s on enamel and dentine, rinse Mix 10 s and apply bulk-fill Apply EQUIA coat and light cure for 20 s
unit
Clearfil Majesty EstheticOther
Apply in 2-mm increment, light cure for 20 s
NexComp FlowOther
Apply in 2-mm increment light cure for 20 s
3M Espe Bulk-fillOther
Apply in single increment up to 4 mm; light curing for 20 s
| Study group | Role | What they receive |
|---|---|---|
| High-viscosity glass ionomer | Experimental | Not described Receives: Other: EQUIA Forte Fil |
| flowable composite | Experimental | Not described Receives: Other: NexComp Flow |
| bulkfill composite | Experimental | Not described Receives: Other: 3M Espe Bulk-fill |
| nanohybrid composite | Experimental | Not described Receives: Other: Clearfil Majesty Esthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of restoration on cervical lesions
According to FDI criteria (aesthetic, biological and fuctional) score 1, clinically very good; score 2, clinically good; score 3, clinically sufficient; score 4, clinically unsatisfactory; score 5, clinically poor. Scores 1-3 show clinically acceptable restoration, while scores 4 and 5 indicate failure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study startJul 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: required license
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noncarious Cervical LesionsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Gül Yıldız Telatar, Dr, Principal investigator, Recep Tayyip Erdogan University Dentistry Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261140
- Sponsor's protocol ID
- 2019/19
- Status last verified
- May 2020
- First submitted
- 4 Feb 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available within 1 years of study completion
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Four Aesthetic Restorations in Non-carious Cervical Lesions: a Randomised Controlled Split-mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT04261140
- Acronym / sponsor ID
- 2019/19
- Conditions
- Noncarious Cervical Lesions
- Keywords
- High-viscosity glass ionomer, bulkfill composite, flowable composite, nanohybrid composite, cervical lesion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: required license
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 7 Feb 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.
To compare the clinical performance of high-viscosity glass ionomer, flowable composite, bulkfill composite and nanohybrid composite restorations in non-carious cervical lesions (NCCLs).
Detailed description
One hundred fourty NCCLs were randomised into four groups according to a split-mouth design. Clinical evaluations will be performed after 1 week, 3 months, 6 months, using FDI (World Dental Federation) criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-viscosity glass ionomer | Experimental | Other: EQUIA Forte Fil |
| flowable composite | Experimental | Other: NexComp Flow |
| bulkfill composite | Experimental | Other: 3M Espe Bulk-fill |
| nanohybrid composite | Experimental | Other: Clearfil Majesty Esthetic |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- had at least four non-carious symmetrical cervical lesions,
- had permanent dentition and were older than 20 years old,
- had cervical margins in dentin
Key exclusion criteria (3 listed)
- periodontal disease
- pregnant or breastfeeding
- being under orthodontic therapy
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 |
|---|---|---|
| EQUIA Forte FilApply cavity conditioner (20% polyacrylic acid) 10 s on enamel and dentine, rinse Mix 10 s and apply bulk-fill Apply EQUIA coat and light cure for 20 s unit | Other | High-viscosity glass ionomer |
| Clearfil Majesty EstheticApply in 2-mm increment, light cure for 20 s | Other | nanohybrid composite |
| NexComp FlowApply in 2-mm increment light cure for 20 s | Other | flowable composite |
| 3M Espe Bulk-fillApply in single increment up to 4 mm; light curing for 20 s | Other | bulkfill composite |
Primary outcome
evaluation of restoration on cervical lesions
Time frame: 6 months
According to FDI criteria (aesthetic, biological and fuctional) score 1, clinically very good; score 2, clinically good; score 3, clinically sufficient; score 4, clinically unsatisfactory; score 5, clinically poor. Scores 1-3 show clinically acceptable restoration, while scores 4 and 5 indicate failure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No. Data will be available within 1 years of study completion
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.
Gül Yıldız Telatar, Dr principal investigator
Recep Tayyip Erdogan University Dentistry Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EQUIA Forte Fil, Clearfil Majesty Esthetic and NexComp Flow in people with Noncarious Cervical Lesions, run by Recep Tayyip Erdogan University Training and Research Hospital 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 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: withdrawn, as of the sponsor's last update on 6 May 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
evaluation of restoration on cervical lesions (time frame: 6 months). 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 6 May 2020.