DiastemaNCT02893735
Clinical Comparison of Two Resin Composites on Diastema Closure and Reshaping at Four Years
A study testing Charisma-Diamond and Filtek-Z550 in people with Diastema, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the clinical performances of nano-hybrid resin composite systems used for anterior diastema closure and tooth reshaping at 4 years in service using FDI Criteria. Twenty-three patients with diastema problem were enrolled. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diastema
- What is being tested?
- Charisma-Diamond and Filtek-Z550
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2011to Aug 2015
- 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
- all subjects were required to be at least 18 years old,
- able to read and sign the informed consent document,
- physically and psychologically able to tolerate conventional restorative procedures,
- having no active periodontal or pulpal diseases,
- having teeth with good restorations, and
- willing to return for follow-up examinations as outlined by the investigators.
Who cannot join
- uncontrolled parafunction;
- insufficient oral hygiene leading to caries lesions more than twice yearly during the previous 2 years;
- being pregnant or nursing; and
- having periodontal or gingival disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University School of Dentistry
Ankara, 06100
About this study
Official title: A Prospective 4-year Clinical Study Evaluating Two Resin Composites on Diastema Closure and Reshaping
The aim of this study was to evaluate the clinical performances of nano-hybrid resin composite systems used for anterior diastema closure and tooth reshaping at 4 years in service using FDI Criteria.
Twenty-three patients with diastema problem were enrolled. Nano-hybrid resin composites to be used on each patient were randomly selected. Thirty-seven teeth (10 patients) were restored with Filtek-Z550 (3M/ESPE) in combination with Adper™ Single Bond 2 (3M/ESPE) in Group 1; whereas 39 teeth (13 patients) were restored with Charisma-Diamond (Heraeus Kulzer) in combination with Gluma2 Bond (Heraeus Kulzer) in Group 2, by two operators. Esthetic, functional and biological properties of the restorations were evaluated at baseline, 1-4 years using FDI Criteria establishing a score-range of 1-5. The data were evaluated using the Fisher's Chi-Square (p=0.05).
Read the detailed description
The aim of this study was to evaluate the clinical performances of nano-hybrid resin composite systems used for anterior diastema closure and tooth reshaping at 4 years in service using FDI Criteria.
The study protocol was approved by the Ethical Committee of Hacettepe University, Ankara, Turkey and the Ethical Committee of Ministry of Health (protocol HEK KA-14004). A total of 23 patients (6 male, 17 female, mean age: 31.27) with maxillary anterior midline or multi-diastema problem received 76 direct composite resin restorations.
The teeth to be restored were first cleaned with pumice-water slurry using a rubber cup. The appropriate shade of restorative material was selected using a standard VITAPAN® Classic shade guide and initial intraoral photographs were taken. Teeth were then isolated using cotton rolls and Mylar strips were placed with the help of wedges interproximally to achieve a smooth and overhang free restoration outline in the cervical area and to form final restorations. The surfaces to be restored were etched using 35% phosphoric or orthophosphoric acid for 30 s according to the restorative system used. The etched surfaces were rinsed and dried. Nano-hybrid resin composite systems to be used on each patient were randomly selected. Thirty seven teeth of 10 patients were restored with Filtek-Z550 (3M/ESPE, St. Paul, MN, USA) in combination with Adper™ Single Bond 2 (3M/ESPE, St. Paul, MN, USA) etch\&rinse adhesive; whereas 39 teeth of 13 patients were restored with Charisma-Diamond (Heraeus Kulzer, GmbH, Germany) in combination with Gluma2 Bond (Heraeus Kulzer, GmbH, Germany) etch\&rinse adhesive by two operators. Materials were used according to the manufacturers' instructions. Two calibrated observers who were blinded to the objective of this study performed the evaluations. For maximum validity, the observers were calibrated by using the web-based training and calibration tool www.e-calib.info recommended by FDI. Both observers evaluated the esthetic, functional and biological properties of the restorations independently at baseline, 1-2-3 and 4 years using FDI Criteria establishing a score-range of 1-5 (1-Clinically excellent/very good, 2-Clinically good, 3-Clinically sufficient/satisfactory, 4-Clinically unsatisfactory and 5-Clinically poor). After data collection, in case of discrepancies in scoring, restorations were evaluated again, a consensus was reached and this was accepted as the final score.
Statistical analysis was performed with SPSS 15.0 software. To compare the performance of restorative materials according to FDI criteria over the study period, the Fisher's Chi-Square test was used. The Cochran's Q test was then used to compare the 1-2-3 and 4-year scores of each material with baseline scores to evaluate the changes of each dependent group by the time. Survival curves were obtained using Kaplan-Meier method. p values less than 0.05 were considered to be statistically significant in all tests.
- Conditions
- Diastema
- Being tested
- Charisma-Diamond, Filtek-Z550
- Keywords
- Clinical Trial, Composite resin
- Medical subject headings
- Diastema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charisma-DiamondOther
The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Nano-hybrid resin composite system was used Charisma-Diamond in combination Gluma2 Bond etch\&rinse adhesive. The composite increments were carefully placed between the matrix strip and tooth by using a hand instrument. The composite resin restorations were light-cured (600 mW/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups whereas; proximal and labial surfaces were contoured and polished with finishing strips. The treatments were completed by instructing the patients about the oral hygiene measures for cleaning their restorations with toothbrush and dental floss.
Filtek-Z550Other
The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Nano-hybrid resin composite system was used Filtek-Z550 in combination with Adper™ Single Bond 2 etch\&rinse adhesive. The composite increments were carefully placed between the matrix strip and tooth by using a hand instrument. The composite resin restorations were light-cured (600 mW/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups whereas; proximal and labial surfaces were contoured and polished with finishing strips. The treatments were completed by instructing the patients about the oral hygiene measures for cleaning their restorations with toothbrush and dental floss.
| Study group | Role | What they receive |
|---|---|---|
| Charisma-Diamond | Active comparator | Charisma Diamond was randomly applied for diastema closure. Receives: Other: Charisma-Diamond |
| Filtek-Z550 | Active comparator | Filtek-Z550 was randomly applied for diastema closure. Receives: Other: Filtek-Z550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of restorations, graded on a 5-point scale, using FDI criteria
This outcome may be classified as "1-Clinically excellent/ very good", "2-Clinically good (after correction, very good)", "3-Clinically sufficient/ satisfactory (minor shortcomings with no adverse effects but not adjustable without damage to the tooth)", "4-Clinically unsatisfactory (repair for prophylactic reasons)", "5-Clinically poor (replacement necessary)" classification of the Esthetic, Functional and Biological properties
Measured: Change from baseline to 4 year outcome of restorations were evaluated.
Secondary outcomes (8)
Surface Luster, graded on a 5-point scale (FDI criteria)
May be classified as "Luster comparable to enamel", "Slightly dull, not noticeable from speaking distance", "Dull surface but acceptable if covered with film of saliva", "Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary", "Quite rough, unacceptable plaque retentive surface"
Measured: Change from baseline to 4 year outcome of restorations were evaluated.
Staining margin, graded on a 5-point scale (FDI criteria)
May be classified as "No surface staining", "Minor staining, easily removable", "Moderate surface staining, also present on other teeth, not aesthetically unacceptable", "Surface staining present on the restoration and is unacceptable; major intervention necessary for improvement", "Severe staining and/or subsurface staining (generalized or localized); not accessible for intervention"
Measured: Change from baseline to 4 year outcome of restorations were evaluated.
Colour stability and translucency, graded on a 5-point scale (FDI criteria)
May be classified as "Good colour match no difference in shade and translucency", "Minor deviations", "Clear deviation but acceptable. Does not affect aesthetics", "(Localised) clinically unsatisfactory but can be corrected by repair", "Unacceptable. Replacement necessary"
Measured: Change from baseline to 4 year outcome of restorations were evaluated.
Fractures and Retention, graded on a 5-point scale (FDI criteria)
May be classified as "Restoration retained, no fractures/cracks", "Small hairline crack", "Two or more or larger hairline cracks and/or chipping(not affecting the marginal integrity or proximal contact", "Chipping fractures which damage marginal quality or proximal contacts; bulk fractures with or without partial loss(less than half of the restoration)", "Partial or complete loss of restoration"
Measured: Change from baseline to 4 year outcome of restorations were evaluated.
Marginal Adaptation, graded on a 5-point scale (FDI criteria)
May be classified as "Harmonious outline, no gaps, no discoloration", "Marginal gap (50 µm) or Small marginal fracture removable by polishing", "Gap< 150 µm not removable or Severe small enamel or dentin fractures", "Gap> 250 µm or dentine exposed or Chip fracture damaging margins or Notable enamel or dentine wall fracture", "Filling is loose but in situ"
Measured: Change from baseline to 4 year outcome of restorations were evaluated.
Postoperative Hypersensibility, tooth vitality, graded on a 5-point scale (FDI criteria)
May be classified as "No hypersensitivity, normal vitality", "Low hypersensitivity for a limited period of time, normal vitality", "Premature/slightly more intense or Delayed/weak sensitivity; no subjective complaints, no treatment needed", "Premature/very intense or Extremely delayed/weak with subjective complaints or Negative sensitivity intervention necessary but not replacement", "Very intense, acute pulpitis or no vital. Endodontic treatment is necessary and restoration has to be replaced"
Measured: Change from baseline to 4 year outcome of restorations were evaluated.
Recurrence of Caries, erosion, abfraction, graded on a 5-point scale (FDI criteria)
May be classified as "No secondary or primary caries", "Very small and localized. No operative treatment required", "Larger areas of: Demineralisation or Erosion or Abrasion/abfraction in dentine. Localized and accessible and can be repaired", "Caries with cavitation or Erosion in dentine or Abrasion/abfraction in dentine Localized and accessible and can be repaired", "Deep secondary caries or exposed dentine that is not accessible for repair of restoration"
Measured: Change from baseline to 4 year outcome of restorations were evaluated.
Tooth integrity (enamel cracks), graded on a 5-point scale (FDI criteria)
May be classified as "Complete integrity", "Small margin enamel(<150 µm) or Hairline crack in enamel (<150 µm not probable)", "Enamel split(<250 µm) or Crack< 250 µm, no adverse effects", "Major enamel split (gap>250 µm or dentine or base exposed) or Crack>250 µm (probe penetrates)", "Cusp or tooth fracture"
Measured: Change from baseline to 4 year outcome of restorations were evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startDec 2011
- Primary completionAug 2015
- Study completionAug 2015
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 DiastemaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Bilge Kutuk, Hacettepe University
- Investigators
- Sevil Gurgan, PhD, DDS, Study director, Hacettepe University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893735
- Sponsor's protocol ID
- 2014/03-4(KA-14004)
- Status last verified
- Sep 2016
- First submitted
- 5 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Ergin E, Kutuk ZB, Oztas SS, Cakir FY, Gurgan S. 6-Months Clinical Comparison of Two Resin Composites on Diastema Closure. J Dent Res (Spec Iss 94 A): 599, 2015
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective 4-year Clinical Study Evaluating Two Resin Composites on Diastema Closure and Reshaping
- ClinicalTrials.gov ID
- NCT02893735
- Acronym / sponsor ID
- 2014/03-4(KA-14004)
- Conditions
- Diastema
- Keywords
- Clinical Trial, Composite resin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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 was to evaluate the clinical performances of nano-hybrid resin composite systems used for anterior diastema closure and tooth reshaping at 4 years in service using FDI Criteria.
Twenty-three patients with diastema problem were enrolled. Nano-hybrid resin composites to be used on each patient were randomly selected. Thirty-seven teeth (10 patients) were restored with Filtek-Z550 (3M/ESPE) in combination with Adper™ Single Bond 2 (3M/ESPE) in Group 1; whereas 39 teeth (13 patients) were restored with Charisma-Diamond (Heraeus Kulzer) in combination with Gluma2 Bond (Heraeus Kulzer) in Group 2, by two operators. Esthetic, functional and biological properties of the restorations were evaluated at baseline, 1-4 years using FDI Criteria establishing a score-range of 1-5. The data were evaluated using the Fisher's Chi-Square (p=0.05).
Detailed description
The aim of this study was to evaluate the clinical performances of nano-hybrid resin composite systems used for anterior diastema closure and tooth reshaping at 4 years in service using FDI Criteria.
The study protocol was approved by the Ethical Committee of Hacettepe University, Ankara, Turkey and the Ethical Committee of Ministry of Health (protocol HEK KA-14004). A total of 23 patients (6 male, 17 female, mean age: 31.27) with maxillary anterior midline or multi-diastema problem received 76 direct composite resin restorations.
The teeth to be restored were first cleaned with pumice-water slurry using a rubber cup. The appropriate shade of restorative material was selected using a standard VITAPAN® Classic shade guide and initial intraoral photographs were taken. Teeth were then isolated using cotton rolls and Mylar strips were placed with the help of wedges interproximally to achieve a smooth and overhang free restoration outline in the cervical area and to form final restorations. The surfaces to be restored were etched using 35% phosphoric or orthophosphoric acid for 30 s according to the restorative system used. The etched surfaces were rinsed and dried. Nano-hybrid resin composite systems to be used on each patient were randomly selected. Thirty seven teeth of 10 patients were restored with Filtek-Z550 (3M/ESPE, St. Paul, MN, USA) in combination with Adper™ Single Bond 2 (3M/ESPE, St. Paul, MN, USA) etch\&rinse adhesive; whereas 39 teeth of 13 patients were restored with Charisma-Diamond (Heraeus Kulzer, GmbH, Germany) in combination with Gluma2 Bond (Heraeus Kulzer, GmbH, Germany) etch\&rinse adhesive by two operators. Materials were used according to the manufacturers' instructions. Two calibrated observers who were blinded to the objective of this study performed the evaluations. For maximum validity, the observers were calibrated by using the web-based training and calibration tool www.e-calib.info recommended by FDI. Both observers evaluated the esthetic, functional and biological properties of the restorations independently at baseline, 1-2-3 and 4 years using FDI Criteria establishing a score-range of 1-5 (1-Clinically excellent/very good, 2-Clinically good, 3-Clinically sufficient/satisfactory, 4-Clinically unsatisfactory and 5-Clinically poor). After data collection, in case of discrepancies in scoring, restorations were evaluated again, a consensus was reached and this was accepted as the final score.
Statistical analysis was performed with SPSS 15.0 software. To compare the performance of restorative materials according to FDI criteria over the study period, the Fisher's Chi-Square test was used. The Cochran's Q test was then used to compare the 1-2-3 and 4-year scores of each material with baseline scores to evaluate the changes of each dependent group by the time. Survival curves were obtained using Kaplan-Meier method. p values less than 0.05 were considered to be statistically significant in all tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Charisma-Diamond | Active comparator | Other: Charisma-DiamondCharisma Diamond was randomly applied for diastema closure. |
| Filtek-Z550 | Active comparator | Other: Filtek-Z550Filtek-Z550 was randomly applied for diastema closure. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- all subjects were required to be at least 18 years old,
- able to read and sign the informed consent document,
- physically and psychologically able to tolerate conventional restorative procedures,
- having no active periodontal or pulpal diseases,
- having teeth with good restorations, and
Key exclusion criteria (4 listed)
- uncontrolled parafunction;
- insufficient oral hygiene leading to caries lesions more than twice yearly during the previous 2 years;
- being pregnant or nursing; and
- having periodontal or gingival disease.
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 |
|---|---|---|
| Charisma-DiamondThe surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Nano-hybrid resin composite system was used Charisma-Diamond in combination Gluma2 Bond etch\&rinse adhesive. The composite increments were carefully placed between the matrix strip and tooth by using a hand instrument. The composite resin restorations were light-cured (600 mW/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups whereas; proximal and labial surfaces were contoured and polished with finishing strips. The treatments were completed by instructing the patients about the oral hygiene measures for cleaning their restorations with toothbrush and dental floss. | Other | Charisma-Diamond |
| Filtek-Z550The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Nano-hybrid resin composite system was used Filtek-Z550 in combination with Adper™ Single Bond 2 etch\&rinse adhesive. The composite increments were carefully placed between the matrix strip and tooth by using a hand instrument. The composite resin restorations were light-cured (600 mW/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups whereas; proximal and labial surfaces were contoured and polished with finishing strips. The treatments were completed by instructing the patients about the oral hygiene measures for cleaning their restorations with toothbrush and dental floss. | Other | Filtek-Z550 |
Primary outcome
Clinical performance of restorations, graded on a 5-point scale, using FDI criteria
Time frame: Change from baseline to 4 year outcome of restorations were evaluated.
This outcome may be classified as "1-Clinically excellent/ very good", "2-Clinically good (after correction, very good)", "3-Clinically sufficient/ satisfactory (minor shortcomings with no adverse effects but not adjustable without damage to the tooth)", "4-Clinically unsatisfactory (repair for prophylactic reasons)", "5-Clinically poor (replacement necessary)" classification of the Esthetic, Functional and Biological properties
8 secondary outcomes
Surface Luster, graded on a 5-point scale (FDI criteria)
Time frame: Change from baseline to 4 year outcome of restorations were evaluated.
Staining margin, graded on a 5-point scale (FDI criteria)
Time frame: Change from baseline to 4 year outcome of restorations were evaluated.
Colour stability and translucency, graded on a 5-point scale (FDI criteria)
Time frame: Change from baseline to 4 year outcome of restorations were evaluated.
Fractures and Retention, graded on a 5-point scale (FDI criteria)
Time frame: Change from baseline to 4 year outcome of restorations were evaluated.
Marginal Adaptation, graded on a 5-point scale (FDI criteria)
Time frame: Change from baseline to 4 year outcome of restorations were evaluated.
Postoperative Hypersensibility, tooth vitality, graded on a 5-point scale (FDI criteria)
Time frame: Change from baseline to 4 year outcome of restorations were evaluated.
Recurrence of Caries, erosion, abfraction, graded on a 5-point scale (FDI criteria)
Time frame: Change from baseline to 4 year outcome of restorations were evaluated.
Tooth integrity (enamel cracks), graded on a 5-point scale (FDI criteria)
Time frame: Change from baseline to 4 year outcome of restorations were evaluated.
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 8 Sep 2016.
- BackgroundErgin E, Kutuk ZB, Oztas SS, Cakir FY, Gurgan S. 6-Months Clinical Comparison of Two Resin Composites on Diastema Closure. J Dent Res (Spec Iss 94 A): 599, 2015
- Individual participant dataSharing planned: Yes
Related trials for Diastema
Not yet recruiting
Diastema Closure and Stability: Clear Aligners vs Fixed Appliances With Laser Frenectomy
Diastema, Generalized Interdental Spaces
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.
Sevil Gurgan, PhD, DDS study director
Hacettepe University School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charisma-Diamond and Filtek-Z550 in people with Diastema, 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 6 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 8 Sep 2016. 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 performance of restorations, graded on a 5-point scale, using FDI criteria (time frame: Change from baseline to 4 year outcome of restorations were evaluated.). 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 NCT02893735, 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 8 Sep 2016.