Peripheral Nerve Facial Nerve ParalysisNCT01327157
Study of a New Technique to Improve the Symptoms of Orofacial Discomfort in Patients With Peripheral Facial Paralysis
A study testing occlusal adjustment. and Visual analog scale. in people with Peripheral Nerve Facial Nerve Paralysis and Facial Nerve Diseases, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study was to evaluate the effects of Neuro Occlusal Rehabilitation (RNO) in patients with peripheral facial palsy (PFP) disease, noting the decrease in symptoms of masticatory dysfunction. According to Carvalho (2009) patients with PFP have chronic unilateral masticatory preference. Santos et al. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Peripheral Nerve Facial Nerve Paralysis, Facial Nerve Diseases, Orofacial Pain
- What is being tested?
- occlusal adjustment. and Visual analog scale.
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with PFP over six months of treatment
- indentations
- carrier fixed partial dentures and removable drives and/or dental implants
- palsy classified as Grade III according to House and Brackmann scale
Who cannot join
- patients who already had other diseases in the region of the jaws before facial paralysis
- is toothless from installing, using or not dentures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuro Occlusal Rehabilitation in Patient With Peripheral Facial Paralysis - a Randomized Clinical Trial
- The purpose of this study was to evaluate the effects of Neuro Occlusal Rehabilitation (RNO) in patients with peripheral facial palsy (PFP) disease, noting the decrease in symptoms of masticatory dysfunction.
- According to Carvalho (2009) patients with PFP have chronic unilateral masticatory preference. Santos et al. (2009) in the same year noted that these conditions can lead to problems with temporomandibular disorder.
- Hypothesis- known that performing occlusal adjustment in these patients with chronic PFP, ensuring a maximum of dental contacts and a final stop of the masticatory cycle stable, providing a balanced occlusion.
- dental cleaning was performed in two groups for the blind study
- visual analog scale -To assess the quality of the oral functions of these patients, the investigators applied the visual analog scale(VAS) and statistically evaluated the degree of satisfaction regarding the functions of oro facial in relation to mastication and temporomandibular dysfunction.
- gnathostatic models were made in the treatment group in the first and last query.
- occlusal adjustment in treatment group.In the group treated occlusal adjustment was made in the teeth and applied a new (VAS) before and after treatment.
The RNO, is defined as a part of medicine that operates in stomatology occlusal plane as a guide to a harmonious development of the face, chewing facilitating bilateral and alternating. (Planas, 1997). It works through selective grinding on the occlusal platform, providing an increased number of dental contacts.
Read the detailed description
Purpose: To evaluate the effects of the Neuro-Rehabilitation occlusion in patients with chronic facial palsy by observing the decrease of the symptoms of masticatory dysfunction.
Methods: a selection of sixty-five patients with facial palsy (PFP 65) and idiopathic chronic trauma of the Otorhinolaryngology sector facial nerve disorders at UNIFESP.
Patients were of both genders, aged between 18 and 60. They were analyzed according to the criteria of inclusion and exclusion, resulting in forty-three patients.
However, due to problems inherent in research, a group of fourteen patients were randomized (sub-divided) into two groups: control and treatment.
The visual analog scale was used at the first consultation to patients in the control and treatment group.
All patients underwent a dental cleaning in order to blind the study. Seven patients belonged to the control group for three months per sequence, the VAS was performed in both groups. The control group was later reunited with the treatment group after three months of control period, increasing the number of patients who were examined in extracts, with similar features in a prognostic factor.
- Control group
- First visit- visual analogue scale and dental cleaning - Day 1
- Second visit, after a month, a new visual analog scale. Day-30
- Third-visit -one months after a new visual analogue scale Day 60 patient was a three visits with an interval of one month, performing a repeat procedure.
- Last visit - Day 90 visual analogue scale
- Treatment group The researchers applied the technique of Rehabilitation and Neuro Occlusal gnathostatic models that were made before and after treatment to count the dental contacts.
- First query - visual analogue scale and dental cleaning, preparation of initial models gnatostaticos and intervention- Day 1
- Second-query-after a month, a new visual analogue and intervention. Day 30
- Third query- -after a month, a new visual analogue and intervention Day 60
- Last query -after a month a new visual analogue scale and making models gnathostatic finals. Day 90 The treatment group had one month to see changes in oral functions, but for estatistic effects was computed only de first andy the last visit the number of the dental contact and the VAS. Day 90 Upon completion of the study patients continued to receive care in the ambulatory clinic of the university, but the attendance for this research was terminated.
- Being tested
- occlusal adjustment., Visual analog scale.
- Keywords
- Facial Paralysis / rehabilitation., Dental Occlusion., Occlusal Adjustment., Malocclusion / therapy.
- Medical subject headings
- Facial Nerve Diseases, Facial Pain, Facial Paralysis, Bites and Stings, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal adjustment.Procedure or surgery
It prompted the patient to perform the act of swallowing for 3 times to reach a terminal axis of rotation of the jaw and from this to start. Will be held palpation of the muscles, masseter and temporal on both sides and compared with the marks of carbon found in the teeth. After starts the adjustment following the rules of Guichet with a cylindrical drill with a thin cut . basic principles 1 Occlusive stress maximum distribution in centric relation 2 The occlusive strengths should by the teeth's major axis.3 When the contact is surface to surface, it must be exchanged to another surface point. 4 Once the stability to the centric relation is achieved, it should be kept. The rules to guide the occlusal adjustment selective grinding .
Visual analog scale.Behavioural
Visual analog scale-Graduation was held on the visual analogue scale in the first and last query to measure discomfort chewing.Graduation was held on the visual analogue scale .in the first and last query to measure discomfort chewing. After graduating dental cleaning was performed, with the purpose of blinding the study, Dental Cleaning.With engine using low speed, brushes, and prophylactic paste is carried out dental cleaning in the teeth of all patient.
Dental Cleaning.With engine using low speed, brushes, and prophylactic paste is carried out dental cleaning in the teeth of all patient.
| Study group | Role | What they receive |
|---|---|---|
| Visual Analog Scale (VAS) | Placebo comparator | Initial consultation, dental cleaning and performing the visual analog scale. Consultation three months after achieving "visual analog scale" final
* VAS and dental cleaning at the first query.
* VAS at the last query. In the second period (91-180 days) that participants have been moved from the Placebo group (VAS) to the Experimental group(Occlusal Adjustment). Receives: Behavioral: Visual analog scale. |
| Occlusal adjustment | Experimental | In all consultations, was performed VAS and occlusal adjustment. Three sessions of intervention are doing. The Gnathostatic models were performed in the first and last query. To reach a terminal axis of rotation of the jaw the patient to perform the act of swallowing for 3 times, and after palpation of the muscles, masseter and temporal on both sides and compared with the marks of carbon found in the teeth and started the adjustment following the rules of Guichet with a cylindrical drill with a thin cut.. The rules to guide the occlusal adjustment selective grinding were in this sequence: Occlusal adjustment to the centric relation: with sliding towards anterior; with sliding towards the medium line; with sliding opposite to the medium line; No sliding. Receives: Procedure: occlusal adjustment.; Behavioral: Visual analog scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analog Scale for Pain Was Used to Grade Discomfort in Chewing After the Installation of Facial Paralysis. Level Zero is the Lack of Discomfort and 10 is the Maximum Degree of Discomfort.
It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002).
Patients were asked to fill the VAS with the following questions.
- Do you chew well?
- How would you classify your chewing at the moment?
- If you have no trouble chewing, the rating is zero.
- If you have any discomfort when you chew, your reference level is five.
- If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale.
Measured: Day 1 (Day 91 for Treatment participants first receiving Placebo)
Brand Carbon Count on Gnathostats Models
Only in the treatment group were done gnatostatic models.The models were placed occluding brought with carbon, using the willis compass to keep occluding the posterior base of the model which are aligned with the rear. A model of the teeth was made to measure the occlusion of the teeth (i.e., the amount of contact between the upper and lower mandibles), and used carbon to count the the number of dental contacts, through the brand carbon made on the model, The dental contacts were counted in the models before and after treatment. The models are made in the first and last query.
Measured: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
Secondary outcomes (1)
Visual Analog Scale
It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002).
Patients were asked to fill the VAS with the following questions. Do you chew well? How would you classify your chewing at the moment? If you have no trouble chewing, the rating is zero. If you have any discomfort when you chew, your reference level is five. If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale.
Measured: After 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve Facial Nerve ParalysisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosana de Queiroz, Federal University of São Paulo
- Investigators
- Rosana Q Costa, master, Principal investigator, Federal University of São PauloRosana Q Costa, Investigator, Principal investigator, Federal University São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327157
- Sponsor's protocol ID
- CEP 0323/08
- Status last verified
- Nov 2017
- First submitted
- 29 Mar 2011
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rahal A, Goffi-Gomez MV. Clinical and electromyographic study of lateral preference in mastication in patients with longstanding peripheral facial paralysis. Int J Orofacial Myology. 2009 Nov;35:19-32.
PubMed 20572435Martin E. [Neuro-occlusal rehabilitation and selective grinding: results after 1 year]. Orthod Fr. 2000 Jan;71(1):57-60. French.
PubMed 10838864Planas P. [Equilibrium and neuro-occlusal rehabilitation]. Orthod Fr. 1992;63 Pt 2:435-41. French.
PubMed 1341730Planas M. [Neuro-occlusal rehabilitation: NOR]. Orthod Fr. 1971;42:333-47. No abstract available. French.
PubMed 5293022Christensen LV, Radue JT. Lateral preference in mastication: an electromyographic study. J Oral Rehabil. 1985 Sep;12(5):429-34. doi: 10.1111/j.1365-2842.1985.tb01548.x.
PubMed 3862802
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro Occlusal Rehabilitation in Patient With Peripheral Facial Paralysis - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01327157
- Acronym / sponsor ID
- CEP 0323/08
- Keywords
- Facial Paralysis / rehabilitation., Dental Occlusion., Occlusal Adjustment., Malocclusion / therapy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Posted 20 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The purpose of this study was to evaluate the effects of Neuro Occlusal Rehabilitation (RNO) in patients with peripheral facial palsy (PFP) disease, noting the decrease in symptoms of masticatory dysfunction.
- According to Carvalho (2009) patients with PFP have chronic unilateral masticatory preference. Santos et al. (2009) in the same year noted that these conditions can lead to problems with temporomandibular disorder.
- Hypothesis- known that performing occlusal adjustment in these patients with chronic PFP, ensuring a maximum of dental contacts and a final stop of the masticatory cycle stable, providing a balanced occlusion.
- dental cleaning was performed in two groups for the blind study
- visual analog scale -To assess the quality of the oral functions of these patients, the investigators applied the visual analog scale(VAS) and statistically evaluated the degree of satisfaction regarding the functions of oro facial in relation to mastication and temporomandibular dysfunction.
- gnathostatic models were made in the treatment group in the first and last query.
- occlusal adjustment in treatment group.In the group treated occlusal adjustment was made in the teeth and applied a new (VAS) before and after treatment.
The RNO, is defined as a part of medicine that operates in stomatology occlusal plane as a guide to a harmonious development of the face, chewing facilitating bilateral and alternating. (Planas, 1997). It works through selective grinding on the occlusal platform, providing an increased number of dental contacts.
Detailed description
Purpose: To evaluate the effects of the Neuro-Rehabilitation occlusion in patients with chronic facial palsy by observing the decrease of the symptoms of masticatory dysfunction.
Methods: a selection of sixty-five patients with facial palsy (PFP 65) and idiopathic chronic trauma of the Otorhinolaryngology sector facial nerve disorders at UNIFESP.
Patients were of both genders, aged between 18 and 60. They were analyzed according to the criteria of inclusion and exclusion, resulting in forty-three patients.
However, due to problems inherent in research, a group of fourteen patients were randomized (sub-divided) into two groups: control and treatment.
The visual analog scale was used at the first consultation to patients in the control and treatment group.
All patients underwent a dental cleaning in order to blind the study. Seven patients belonged to the control group for three months per sequence, the VAS was performed in both groups. The control group was later reunited with the treatment group after three months of control period, increasing the number of patients who were examined in extracts, with similar features in a prognostic factor.
- Control group
- First visit- visual analogue scale and dental cleaning - Day 1
- Second visit, after a month, a new visual analog scale. Day-30
- Third-visit -one months after a new visual analogue scale Day 60 patient was a three visits with an interval of one month, performing a repeat procedure.
- Last visit - Day 90 visual analogue scale
- Treatment group The researchers applied the technique of Rehabilitation and Neuro Occlusal gnathostatic models that were made before and after treatment to count the dental contacts.
- First query - visual analogue scale and dental cleaning, preparation of initial models gnatostaticos and intervention- Day 1
- Second-query-after a month, a new visual analogue and intervention. Day 30
- Third query- -after a month, a new visual analogue and intervention Day 60
- Last query -after a month a new visual analogue scale and making models gnathostatic finals. Day 90 The treatment group had one month to see changes in oral functions, but for estatistic effects was computed only de first andy the last visit the number of the dental contact and the VAS. Day 90 Upon completion of the study patients continued to receive care in the ambulatory clinic of the university, but the attendance for this research was terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Analog Scale (VAS) | Placebo comparator | Behavioral: Visual analog scale.Initial consultation, dental cleaning and performing the visual analog scale. Consultation three months after achieving "visual analog scale" final * VAS and dental cleaning at the first query. * VAS at the last query. In the second period (91-180 days) that participants have been moved from the Placebo group (VAS) to the Experimental group(Occlusal Adjustment). |
| Occlusal adjustment | Experimental | Procedure: occlusal adjustment., Behavioral: Visual analog scale.In all consultations, was performed VAS and occlusal adjustment. Three sessions of intervention are doing. The Gnathostatic models were performed in the first and last query. To reach a terminal axis of rotation of the jaw the patient to perform the act of swallowing for 3 times, and after palpation of the muscles, masseter and temporal on both sides and compared with the marks of carbon found in the teeth and started the adjustment following the rules of Guichet with a cylindrical drill with a thin cut.. The rules to guide the occlusal adjustment selective grinding were in this sequence: Occlusal adjustment to the centric relation: with sliding towards anterior; with sliding towards the medium line; with sliding opposite to the medium line; No sliding. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with PFP over six months of treatment
- indentations
- carrier fixed partial dentures and removable drives and/or dental implants
- palsy classified as Grade III according to House and Brackmann scale
Key exclusion criteria (2 listed)
- patients who already had other diseases in the region of the jaws before facial paralysis
- is toothless from installing, using or not dentures
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 |
|---|---|---|
| occlusal adjustment.It prompted the patient to perform the act of swallowing for 3 times to reach a terminal axis of rotation of the jaw and from this to start. Will be held palpation of the muscles, masseter and temporal on both sides and compared with the marks of carbon found in the teeth. After starts the adjustment following the rules of Guichet with a cylindrical drill with a thin cut . basic principles 1 Occlusive stress maximum distribution in centric relation 2 The occlusive strengths should by the teeth's major axis.3 When the contact is surface to surface, it must be exchanged to another surface point. 4 Once the stability to the centric relation is achieved, it should be kept. The rules to guide the occlusal adjustment selective grinding . | Procedure or surgery | Occlusal adjustment |
| Visual analog scale.Visual analog scale-Graduation was held on the visual analogue scale in the first and last query to measure discomfort chewing.Graduation was held on the visual analogue scale .in the first and last query to measure discomfort chewing. After graduating dental cleaning was performed, with the purpose of blinding the study, Dental Cleaning.With engine using low speed, brushes, and prophylactic paste is carried out dental cleaning in the teeth of all patient. Dental Cleaning.With engine using low speed, brushes, and prophylactic paste is carried out dental cleaning in the teeth of all patient. | Behavioural | Occlusal adjustment, Visual Analog Scale (VAS) |
Primary outcome
The Visual Analog Scale for Pain Was Used to Grade Discomfort in Chewing After the Installation of Facial Paralysis. Level Zero is the Lack of Discomfort and 10 is the Maximum Degree of Discomfort.
Time frame: Day 1 (Day 91 for Treatment participants first receiving Placebo)
It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002). Patients were asked to fill the VAS with the following questions. * Do you chew well? * How would you classify your chewing at the moment? * If you have no trouble chewing, the rating is zero. * If you have any discomfort when you chew, your reference level is five. * If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale.
Brand Carbon Count on Gnathostats Models
Time frame: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
Only in the treatment group were done gnatostatic models.The models were placed occluding brought with carbon, using the willis compass to keep occluding the posterior base of the model which are aligned with the rear. A model of the teeth was made to measure the occlusion of the teeth (i.e., the amount of contact between the upper and lower mandibles), and used carbon to count the the number of dental contacts, through the brand carbon made on the model, The dental contacts were counted in the models before and after treatment. The models are made in the first and last query.
1 secondary outcome
Visual Analog Scale
Time frame: After 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20572435Rahal A, Goffi-Gomez MV. Clinical and electromyographic study of lateral preference in mastication in patients with longstanding peripheral facial paralysis. Int J Orofacial Myology. 2009 Nov;35:19-32.
- Background: PubMed 10838864Martin E. [Neuro-occlusal rehabilitation and selective grinding: results after 1 year]. Orthod Fr. 2000 Jan;71(1):57-60. French.
- Background: PubMed 1341730Planas P. [Equilibrium and neuro-occlusal rehabilitation]. Orthod Fr. 1992;63 Pt 2:435-41. French.
- Background: PubMed 5293022Planas M. [Neuro-occlusal rehabilitation: NOR]. Orthod Fr. 1971;42:333-47. No abstract available. French.
- Background: PubMed 3862802Christensen LV, Radue JT. Lateral preference in mastication: an electromyographic study. J Oral Rehabil. 1985 Sep;12(5):429-34. doi: 10.1111/j.1365-2842.1985.tb01548.x.
- 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.
Rosana Q Costa, master principal investigator
Federal University of São Paulo
Rosana Q Costa, Investigator principal investigator
Federal University São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occlusal adjustment. and Visual analog scale. in people with Peripheral Nerve Facial Nerve Paralysis and Facial Nerve Diseases, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 2 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 20 Aug 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Visual Analog Scale for Pain Was Used to Grade Discomfort in Chewing After the Installation of Facial Paralysis. Level Zero is the Lack of Discomfort and 10 is the Maximum Degree of Discomfort. (time frame: Day 1 (Day 91 for Treatment participants first receiving Placebo)). The study lists 2 primary outcomes in all. 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 NCT01327157, which also lists 5 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 20 Aug 2018.