Tooth ErosionUOVTDENCT03112278
Clinical Evaluation of Ultrathin Occlusal Veneers for the Treatment of Severe Dental Erosion
A study testing Ceramic ultrathin occlusal veneers and Composite resin ultrathin occlusal veneers in people with Tooth Erosion and Teeth Erosion Due to Vomiting, run by Universidade Federal do Rio de Janeiro.
Trial summary
Ultra-thin bonded posterior occlusal veneers represent a conservative alternative to traditional onlays and complete coverage crowns for the treatment of severe erosive lesions. Therefore, the purpose of this study is to determine whether ceramic and composite resin ultrathin occlusal veneers (0.6 - 1.0 mm thick) are… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Tooth Erosion, Teeth Erosion Due to Vomiting, Teeth Erosion Limited to the Enamel
- What is being tested?
- Ceramic ultrathin occlusal veneers and Composite resin ultrathin occlusal veneers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to 2 Apr 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting advanced erosive lesions ( cumulative score in all sextants greater than or equal 14, according to classification of BARLETT; GANSS; LUSSI, 2008).
- Absence of pain from the tooth to be restored (excluding expected sensitivity due to dentin exposure due to severe erosion).
- Application of rubber dam possible
- High level of oral hygiene.
- Absence of any active periodontal and pulpal disease.
- Willingness to wear a nightguard to protect the restorations in case of associated bruxism.
Who cannot join
- patients with low level of oral hygiene after all the attempts to improve it failed.
About this study
Ultra-thin bonded posterior occlusal veneers represent a conservative alternative to traditional onlays and complete coverage crowns for the treatment of severe erosive lesions. Therefore, the purpose of this study is to determine whether ceramic and composite resin ultrathin occlusal veneers (0.6 - 1.0 mm thick) are effective in the rehabilitation of patients affected by moderate and severe dental erosion.
Read the detailed description
Along with data collection, complete arch polyvinyl siloxane impressions are made to obtain accurate diagnostic casts. The occlusal relationship is recorded either at the maximum intercuspal position or centric relation (in cases occlusal space is needed for the restoration of the palatal of upper anterior teeth). An additive waxing is carried out for the eroded teeth. The waxed cast is then duplicated and poured with scannable stone.
An average occlusal clearance of 0.4 to 0.6 mm (central groove) to 1.0 to 1.3 mm (cusp tips) is generated by means of rotary diamond burs for the ultrathin occlusal veneers. A rubber dam is placed, and all areas of dentin exposure are ground with a coarse diamond rotary instrument at low speed (1500 rpm) and immediately sealed using a 3-step etch-and-rinse dentin bonding agent. The additive wax replica is scanned first for correlation (Cerec Bluecam; Sirona Dental Systems). The prepared teeth are then scanned in the same way.
The teeth are restored using Cerec AC with the Bluecam/MCXL CAD/CAM system (Sirona Dental Systems). By using the design tools of the software set in Biogeneric Copy, the restorations are designed by correlating the preparations with the anatomy of the additive waxing. The ultrathin occlusal veneers are milled either from composite resin blocks (LAVA Ultimate; 3M ESPE) or ceramic blocks (e.max CAD; Ivoclar Vivadent) and polished mechanically with silicon carbide-impregnated brushes.
Restorations are then adhesively cemented. After being air-dried, the intaglio surfaces are silanated and heat dried at 68 oC for 5 minutes (Calset; AdDent Inc). The tooth preparations are airborne-particle abraded and etched for 30 seconds with 37.5% phosphoric acid, rinsed, and dried. Adhesive resin (Optibond FL, bottle 2; Kerr Corp) is applied to both fitting surfaces of the restoration. After the luting material (Filtek Z100; 3M ESPE), preheated to 68oC (in Calset; AdDent), is applied to the tooth, the restorations were individually seated, followed by the elimination of excess composite resin and initial light polymerization. Each surface is exposed at 1000 mW/cm2 for 1 minute (20 seconds per surface, repeated 3 times). Margins are then covered with an air barrier and light polymerized for an additional 20 seconds. Margins are finished and polished at the following appointment with diamond ceramic polishers and silicon impregnated rubber polishers.
Patients are called for a base line evaluation followed by additional evaluations after 1 year, 2 years and 4 years.
Patients Registries:
Patients' registries are made in paper forms and immediately digitalized for safety. The form is stored inside an identified folder containing other patient's documents related to the treatment.
Upon completion of the registry all data is verified by a third person to check for completeness, calibration and accuracy.
Two researchers linked to the project perform patient recruitment (not the evaluators). Patients are interviewed and seen for data collection. If eligibility criteria are meet, the patient receives a comprehensive explanation (accessible language) about the protocol and an invitation to participate.
Despite evaluators were previously calibrated; detailed description of the criteria (based on USPHS) is available to the evaluator at every data collection (follow-up appointments).
Patients are seen at clinic of the Department of Prosthodontics and Dental Materials of the Dental School of UFRJ. During the follow-up appointments data is collected in sequence by two calibrated evaluators. In case of divergence, a consensus is achieved. Intraoral evaluation is performed with dental explorer and mouth mirror assisted by dental operatory light as well as well as a LED transilluminator for crack chasing. In case of failure (cracks longer than 2 mm, lost fragments or bulk debondings) patients are assigned for repair or change of restoration.
The sample of 5 patients for each group was based on the following formula: n = (Zα/2+Zβ)2 * (p1(1-p1)+p2(1-p2)) / (p1-p2)2, with a confidence level of 95%, power of 80% and the survival rates of 90% and 20% for composite and ceramic restorations, respectively (based on previous published data of in vitro fatigue tests).
- Conditions
- Tooth Erosion, Teeth Erosion Due to Vomiting, Teeth Erosion Limited to the Enamel, Teeth Erosion Extending Into the Dentine
- Being tested
- Ceramic ultrathin occlusal veneers, Composite resin ultrathin occlusal veneers
- Keywords
- tooth erosion, Computer-Aided Design, occlusal veneers, dental veneers
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic ultrathin occlusal veneersProcedure or surgery
Severely eroded teeth will be restored with ultrathin occlusal veneers made of ceramic (e.max CAD/Ivoclar Vivadent) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick).
Composite resin ultrathin occlusal veneersProcedure or surgery
Severely eroded teeth will be restored ultrathin occlusal veneers made of composite resin (Lava Ultimate/3M Espe) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick).
| Study group | Role | What they receive |
|---|---|---|
| Ceramic restorations | Active comparator | Ceramic ultrathin occlusal veneers Receives: Procedure: Ceramic ultrathin occlusal veneers |
| Composite resin restorations | Active comparator | Composite resin ultrathin occlusal veneers Receives: Procedure: Composite resin ultrathin occlusal veneers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of ultrathin occlusal veneers (ceramic and composite resin) for the restorative treatment of severe dental erosion.
Measured: 1Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startNov 2015
- Primary completion14 Apr 2017
- Study completion2 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Tooth ErosionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Henrique Schlichting, Universidade Federal do Rio de Janeiro
- Investigators
- Luis H Schlichting, PhD, Principal investigator, Federal University of Rio de Janeiro and East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112278
- Sponsor's protocol ID
- E-26/112.046
- Acronym
- UOVTDE
- Status last verified
- Oct 2017
- First submitted
- 4 Apr 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bindl A, Mormann WH. Survival rate of mono-ceramic and ceramic-core CAD/CAM-generated anterior crowns over 2-5 years. Eur J Oral Sci. 2004 Apr;112(2):197-204. doi: 10.1111/j.1600-0722.2004.00119.x.
PubMed 15056119Burke FJ. Maximising the fracture resistance of dentine-bonded all-ceramic crowns. J Dent. 1999 Mar;27(3):169-73. doi: 10.1016/s0300-5712(98)00050-5.
PubMed 10079622Edelhoff D, Sorensen JA. Tooth structure removal associated with various preparation designs for posterior teeth. Int J Periodontics Restorative Dent. 2002 Jun;22(3):241-9.
PubMed 12186346Edelhoff D, Sorensen JA. Tooth structure removal associated with various preparation designs for anterior teeth. J Prosthet Dent. 2002 May;87(5):503-9. doi: 10.1067/mpr.2002.124094.
PubMed 12070513Fennis WM, Kuijs RH, Kreulen CM, Verdonschot N, Creugers NH. Fatigue resistance of teeth restored with cuspal-coverage composite restorations. Int J Prosthodont. 2004 May-Jun;17(3):313-7.
PubMed 15237878Jaeggi T, Lussi A. Prevalence, incidence and distribution of erosion. Monogr Oral Sci. 2006;20:44-65. doi: 10.1159/000093350.
PubMed 16687884Kunzelmann KH, Jelen B, Mehl A, Hickel R. Wear evaluation of MZ100 compared to ceramic CAD/CAM materials. Int J Comput Dent. 2001 Jul;4(3):171-84. English, German.
PubMed 11862884Leinfelder KF. Ask the expert. Will ceramic restorations be challenged in the future? J Am Dent Assoc. 2001 Jan;132(1):46-7. doi: 10.14219/jada.archive.2001.0024. No abstract available.
PubMed 11194398Lussi A, Hellwig E, Ganss C, Jaeggi T. Buonocore Memorial Lecture. Dental erosion. Oper Dent. 2009 May-Jun;34(3):251-62. doi: 10.2341/09-BL.
PubMed 19544813Magne P. Composite resins and bonded porcelain: the postamalgam era? J Calif Dent Assoc. 2006 Feb;34(2):135-47.
PubMed 16724469Magne P, Schlichting LH, Maia HP, Baratieri LN. In vitro fatigue resistance of CAD/CAM composite resin and ceramic posterior occlusal veneers. J Prosthet Dent. 2010 Sep;104(3):149-57. doi: 10.1016/S0022-3913(10)60111-4.
PubMed 20813228Manhart J, Chen H, Hamm G, Hickel R. Buonocore Memorial Lecture. Review of the clinical survival of direct and indirect restorations in posterior teeth of the permanent dentition. Oper Dent. 2004 Sep-Oct;29(5):481-508.
PubMed 15470871Magne P, Stanley K, Schlichting LH. Modeling of ultrathin occlusal veneers. Dent Mater. 2012 Jul;28(7):777-82. doi: 10.1016/j.dental.2012.04.002. Epub 2012 May 9.
PubMed 22575740Schlichting LH, Maia HP, Baratieri LN, Magne P. Novel-design ultra-thin CAD/CAM composite resin and ceramic occlusal veneers for the treatment of severe dental erosion. J Prosthet Dent. 2011 Apr;105(4):217-26. doi: 10.1016/S0022-3913(11)60035-8.
PubMed 21458646Tsitrou EA, van Noort R. Minimal preparation designs for single posterior indirect prostheses with the use of the Cerec system. Int J Comput Dent. 2008;11(3-4):227-40. English, German.
PubMed 19216314
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Ultrathin Occlusal Veneers for the Treatment of Severe Dental Erosion
- ClinicalTrials.gov ID
- NCT03112278
- Acronym / sponsor ID
- UOVTDE / E-26/112.046
- Conditions
- Tooth Erosion, Teeth Erosion Due to Vomiting, Teeth Erosion Limited to the Enamel, Teeth Erosion Extending Into the Dentine
- Keywords
- tooth erosion, Computer-Aided Design, occlusal veneers, dental veneers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 2 Apr 2021 (estimated)
- First posted
- 13 Apr 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.
Ultra-thin bonded posterior occlusal veneers represent a conservative alternative to traditional onlays and complete coverage crowns for the treatment of severe erosive lesions. Therefore, the purpose of this study is to determine whether ceramic and composite resin ultrathin occlusal veneers (0.6 - 1.0 mm thick) are effective in the rehabilitation of patients affected by moderate and severe dental erosion.
Detailed description
Along with data collection, complete arch polyvinyl siloxane impressions are made to obtain accurate diagnostic casts. The occlusal relationship is recorded either at the maximum intercuspal position or centric relation (in cases occlusal space is needed for the restoration of the palatal of upper anterior teeth). An additive waxing is carried out for the eroded teeth. The waxed cast is then duplicated and poured with scannable stone.
An average occlusal clearance of 0.4 to 0.6 mm (central groove) to 1.0 to 1.3 mm (cusp tips) is generated by means of rotary diamond burs for the ultrathin occlusal veneers. A rubber dam is placed, and all areas of dentin exposure are ground with a coarse diamond rotary instrument at low speed (1500 rpm) and immediately sealed using a 3-step etch-and-rinse dentin bonding agent. The additive wax replica is scanned first for correlation (Cerec Bluecam; Sirona Dental Systems). The prepared teeth are then scanned in the same way.
The teeth are restored using Cerec AC with the Bluecam/MCXL CAD/CAM system (Sirona Dental Systems). By using the design tools of the software set in Biogeneric Copy, the restorations are designed by correlating the preparations with the anatomy of the additive waxing. The ultrathin occlusal veneers are milled either from composite resin blocks (LAVA Ultimate; 3M ESPE) or ceramic blocks (e.max CAD; Ivoclar Vivadent) and polished mechanically with silicon carbide-impregnated brushes.
Restorations are then adhesively cemented. After being air-dried, the intaglio surfaces are silanated and heat dried at 68 oC for 5 minutes (Calset; AdDent Inc). The tooth preparations are airborne-particle abraded and etched for 30 seconds with 37.5% phosphoric acid, rinsed, and dried. Adhesive resin (Optibond FL, bottle 2; Kerr Corp) is applied to both fitting surfaces of the restoration. After the luting material (Filtek Z100; 3M ESPE), preheated to 68oC (in Calset; AdDent), is applied to the tooth, the restorations were individually seated, followed by the elimination of excess composite resin and initial light polymerization. Each surface is exposed at 1000 mW/cm2 for 1 minute (20 seconds per surface, repeated 3 times). Margins are then covered with an air barrier and light polymerized for an additional 20 seconds. Margins are finished and polished at the following appointment with diamond ceramic polishers and silicon impregnated rubber polishers.
Patients are called for a base line evaluation followed by additional evaluations after 1 year, 2 years and 4 years.
Patients Registries:
Patients' registries are made in paper forms and immediately digitalized for safety. The form is stored inside an identified folder containing other patient's documents related to the treatment.
Upon completion of the registry all data is verified by a third person to check for completeness, calibration and accuracy.
Two researchers linked to the project perform patient recruitment (not the evaluators). Patients are interviewed and seen for data collection. If eligibility criteria are meet, the patient receives a comprehensive explanation (accessible language) about the protocol and an invitation to participate.
Despite evaluators were previously calibrated; detailed description of the criteria (based on USPHS) is available to the evaluator at every data collection (follow-up appointments).
Patients are seen at clinic of the Department of Prosthodontics and Dental Materials of the Dental School of UFRJ. During the follow-up appointments data is collected in sequence by two calibrated evaluators. In case of divergence, a consensus is achieved. Intraoral evaluation is performed with dental explorer and mouth mirror assisted by dental operatory light as well as well as a LED transilluminator for crack chasing. In case of failure (cracks longer than 2 mm, lost fragments or bulk debondings) patients are assigned for repair or change of restoration.
The sample of 5 patients for each group was based on the following formula: n = (Zα/2+Zβ)2 * (p1(1-p1)+p2(1-p2)) / (p1-p2)2, with a confidence level of 95%, power of 80% and the survival rates of 90% and 20% for composite and ceramic restorations, respectively (based on previous published data of in vitro fatigue tests).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceramic restorations | Active comparator | Procedure: Ceramic ultrathin occlusal veneersCeramic ultrathin occlusal veneers |
| Composite resin restorations | Active comparator | Procedure: Composite resin ultrathin occlusal veneersComposite resin ultrathin occlusal veneers |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients presenting advanced erosive lesions ( cumulative score in all sextants greater than or equal 14, according to classification of BARLETT; GANSS; LUSSI, 2008).
- Absence of pain from the tooth to be restored (excluding expected sensitivity due to dentin exposure due to severe erosion).
- Application of rubber dam possible
- High level of oral hygiene.
- Absence of any active periodontal and pulpal disease.
Key exclusion criteria (1 listed)
- patients with low level of oral hygiene after all the attempts to improve it failed.
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 |
|---|---|---|
| Ceramic ultrathin occlusal veneersSeverely eroded teeth will be restored with ultrathin occlusal veneers made of ceramic (e.max CAD/Ivoclar Vivadent) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick). | Procedure or surgery | Ceramic restorations |
| Composite resin ultrathin occlusal veneersSeverely eroded teeth will be restored ultrathin occlusal veneers made of composite resin (Lava Ultimate/3M Espe) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick). | Procedure or surgery | Composite resin restorations |
Primary outcome
Survival of ultrathin occlusal veneers (ceramic and composite resin) for the restorative treatment of severe dental erosion.
Time frame: 1Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Background: PubMed 15056119Bindl A, Mormann WH. Survival rate of mono-ceramic and ceramic-core CAD/CAM-generated anterior crowns over 2-5 years. Eur J Oral Sci. 2004 Apr;112(2):197-204. doi: 10.1111/j.1600-0722.2004.00119.x.
- Background: PubMed 10079622Burke FJ. Maximising the fracture resistance of dentine-bonded all-ceramic crowns. J Dent. 1999 Mar;27(3):169-73. doi: 10.1016/s0300-5712(98)00050-5.
- Background: PubMed 12186346Edelhoff D, Sorensen JA. Tooth structure removal associated with various preparation designs for posterior teeth. Int J Periodontics Restorative Dent. 2002 Jun;22(3):241-9.
- Background: PubMed 12070513Edelhoff D, Sorensen JA. Tooth structure removal associated with various preparation designs for anterior teeth. J Prosthet Dent. 2002 May;87(5):503-9. doi: 10.1067/mpr.2002.124094.
- Background: PubMed 15237878Fennis WM, Kuijs RH, Kreulen CM, Verdonschot N, Creugers NH. Fatigue resistance of teeth restored with cuspal-coverage composite restorations. Int J Prosthodont. 2004 May-Jun;17(3):313-7.
- Background: PubMed 16687884Jaeggi T, Lussi A. Prevalence, incidence and distribution of erosion. Monogr Oral Sci. 2006;20:44-65. doi: 10.1159/000093350.
- Background: PubMed 11862884Kunzelmann KH, Jelen B, Mehl A, Hickel R. Wear evaluation of MZ100 compared to ceramic CAD/CAM materials. Int J Comput Dent. 2001 Jul;4(3):171-84. English, German.
- Background: PubMed 11194398Leinfelder KF. Ask the expert. Will ceramic restorations be challenged in the future? J Am Dent Assoc. 2001 Jan;132(1):46-7. doi: 10.14219/jada.archive.2001.0024. No abstract available.
- Background: PubMed 19544813Lussi A, Hellwig E, Ganss C, Jaeggi T. Buonocore Memorial Lecture. Dental erosion. Oper Dent. 2009 May-Jun;34(3):251-62. doi: 10.2341/09-BL.
- Background: PubMed 16724469Magne P. Composite resins and bonded porcelain: the postamalgam era? J Calif Dent Assoc. 2006 Feb;34(2):135-47.
- Background: PubMed 20813228Magne P, Schlichting LH, Maia HP, Baratieri LN. In vitro fatigue resistance of CAD/CAM composite resin and ceramic posterior occlusal veneers. J Prosthet Dent. 2010 Sep;104(3):149-57. doi: 10.1016/S0022-3913(10)60111-4.
- Background: PubMed 15470871Manhart J, Chen H, Hamm G, Hickel R. Buonocore Memorial Lecture. Review of the clinical survival of direct and indirect restorations in posterior teeth of the permanent dentition. Oper Dent. 2004 Sep-Oct;29(5):481-508.
- 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.
Luis H Schlichting, PhD principal investigator
Federal University of Rio de Janeiro and East Carolina University
Questions about this trial
What is this clinical trial studying?
A study testing Ceramic ultrathin occlusal veneers and Composite resin ultrathin occlusal veneers in people with Tooth Erosion and Teeth Erosion Due to Vomiting, run by Universidade Federal do Rio de Janeiro.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Oct 2017. 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?
Results are not available in the source record.
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?
Survival of ultrathin occlusal veneers (ceramic and composite resin) for the restorative treatment of severe dental erosion. (time frame: 1Year). 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 NCT03112278, which also lists 17 linked publications.
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 26 Oct 2017.