Open BiteNCT05657522

Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

A study testing Rapid molar intruder in people with Open Bite, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study evaluated the efficacy of rapid molar intruder (RMI) in treating anterior open bite in the mixed dentition. The study sample consisted of 40 patients who had a skeletal anterior open bite. The sample was allocated randomly into two groups: the RMI group and the control group. Read more about this study

Who is it for?: Ages 8 to 12 years
Conditions the study is for: Open Bite
What is being tested?: Rapid molar intruder
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSyria
Study dates: 25 Sep 2013to 20 Jan 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 8 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients in the mixed dentition
Chronological age between 8 and 12 years
skeletal class I or II malocclusion
Skeletal anterior open bite was assessed clinically and then confirmed radiographically: SN/GoMe was greater than 33°, MM was greater than 27
No general problems
Good oral health

Who cannot join

Presence of periodontal diseases
Presence of general diseases, syndromes or cleft lip and palate
Patients with previous orthodontic treatment

Trial locations and contacts

1 site in 1 country.

Syria1 site

University of Damascus
Damascus

Other trials in Syria

About this study

Official title: Short-term Soft and Hard Tissue Changes Following Skeletal Anterior Open Bite Treatment Using the Rapid Molar Intruder

Read the detailed description

Many appliances have been used to treat skeletal anterior open bite (AOB) malocclusion, such as removable appliances, extra-oral appliances (vertical chin cup and vertical head gear), fixed appliances, Orthognathic surgery and functional appliances. Treatment with these appliances produces soft and hard dentofacial tissue changes. Many studies have been carried out in order to study these changes.

In this study, the investigators treated AOB using RMI. Patients were divided into two groups to evaluate the efficacy of RMI.

RMI group: Rapid molar intruder was applied. Control group: Untreated control group. In order to evaluate the changes occurring, lateral cephalometric images were taken in both groups at the beginning of the treatment (T1) and after 9 months of the first cephalograms (T2).

Conditions: Open Bite
Being tested: Rapid molar intruder
Keywords: Anterior open bite, Rapid molar intruder, Mixed dentition
Medical subject headings: Open Bite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rapid molar intruderDevice
The rapid molar intruder was applied.

Study groups in NCT05657522
Study group	Role	What they receive
Rapid Molar Intruder	Experimental	Patients in this group will undergo the interventional procedure, which is the application of the rapid molar intruder appliance. This will help in correcting the open bite. Receives: Device: Rapid molar intruder
Untreated Control Group	No intervention	Patients in this group will be monitored without any active treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the SNA angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the SNB angle.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the ANB angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the MM angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the SN-OCP angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the occlusion plane and the cranial base in the cephalometric analysis in the vertical direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the SN-MP angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower jaw plane and the cranial base in the cephalometric analysis in the vertical direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the SN-SPP angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper jaw plane and the cranial base in the cephalometric analysis in the vertical direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the overbite (Ovb)
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the overjet (Ovj)
Lateral cephalometric images were taken for each patient. This was measured in millimetres Horizontally from the upper to the lower central incisors.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the UI- LI angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper and the lower incisor axis in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the NS-GN angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the growth pattern of the mandible in the cephalometric analysis in the vertical direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the posterior facial height (S-Go)
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from S point to GO point.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the anterior facial height (N-Me)
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from N point to Me point.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the U1-Palatal plane measurement
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper central incisor apex and the palatal plane.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the U6-Palatal plane measurement
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the tip of the mesial cusp of the upper first molar and the palatal plane.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the L1-GoMe measurement
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the lower central incisor apex and the mandibular plane.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the L6-GoMe measurement
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the tip of the mesial cusp of the lower first molar and the mandibular plane.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

Secondary outcomes (4)

Change in the Li-Esth measurement
Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale inferius and E-Line of Ricketts.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the Ls-Esth measurement
Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale superius and E-Line of Ricketts.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the Nasolabial angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the nose and the upper lip in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the Mentolabial angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the chin and the lower lip in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 201320 Jan 2015

First posted20 Dec 2022
Study start25 Sep 2013
Primary completion20 Apr 2014
Study completion20 Jan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Open BiteStudies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05657522
Sponsor's protocol ID: UDDS-Ortho-17-2022
Status last verified: Dec 2022
First submitted: 11 Dec 2022
Last updated: 20 Dec 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pisani L, Bonaccorso L, Fastuca R, Spena R, Lombardo L, Caprioglio A. Systematic review for orthodontic and orthopedic treatments for anterior open bite in the mixed dentition. Prog Orthod. 2016 Dec;17(1):28. doi: 10.1186/s40510-016-0142-0. Epub 2016 Sep 19.
PubMed 27615261
Feres MF, Abreu LG, Insabralde NM, de Almeida MR, Flores-Mir C. Effectiveness of open bite correction when managing deleterious oral habits in growing children and adolescents: a systematic review and meta-analysis. Eur J Orthod. 2017 Feb;39(1):31-42. doi: 10.1093/ejo/cjw005. Epub 2016 Feb 3.
PubMed 26846264
Turkkahraman H, Cetin E. Comparison of two treatment strategies for the early treatment of an anterior skeletal open bite : Posterior bite block-vertical pull chin cup (PBB-VPC) vs. posterior bite block-high pull headgear (PBB-HPH). J Orofac Orthop. 2017 Jul;78(4):338-347. doi: 10.1007/s00056-017-0095-z. Epub 2017 May 9.
PubMed 28488080
Meibodi SE, Fatahi Meybodi S, Samadi AH. The effect of posterior bite-plane on dentoskeletal changes in skeletal open-bite malocclusion. J Indian Soc Pedod Prev Dent. 2009 Oct-Dec;27(4):202-4. doi: 10.4103/0970-4388.57653.
PubMed 19915269
Cinsar A, Alagha AR, Akyalcin S. Skeletal open bite correction with rapid molar intruder appliance in growing individuals. Angle Orthod. 2007 Jul;77(4):632-9. doi: 10.2319/071406-292.
PubMed 17605497

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Open Bite trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short-term Soft and Hard Tissue Changes Following Skeletal Anterior Open Bite Treatment Using the Rapid Molar Intruder
ClinicalTrials.gov ID: NCT05657522
Acronym / sponsor ID: UDDS-Ortho-17-2022
Conditions: Open Bite
Keywords: Anterior open bite, Rapid molar intruder, Mixed dentition
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 25 Sep 2013 (actual)
Primary completion: 20 Apr 2014 (actual)
Study completion: 20 Jan 2015 (actual)
First posted: 20 Dec 2022 (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.

Detailed description

In this study, the investigators treated AOB using RMI. Patients were divided into two groups to evaluate the efficacy of RMI.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Rapid Molar Intruder	Experimental	Device: Rapid molar intruderPatients in this group will undergo the interventional procedure, which is the application of the rapid molar intruder appliance. This will help in correcting the open bite.
Untreated Control Group	No intervention	–Patients in this group will be monitored without any active treatment.

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Patients in the mixed dentition
Chronological age between 8 and 12 years
skeletal class I or II malocclusion
Skeletal anterior open bite was assessed clinically and then confirmed radiographically: SN/GoMe was greater than 33°, MM was greater than 27
No general problems

Key exclusion criteria (3 listed)

Presence of periodontal diseases
Presence of general diseases, syndromes or cleft lip and palate
Patients with previous orthodontic treatment

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
Rapid molar intruderThe rapid molar intruder was applied.	Device	Rapid Molar Intruder

Primary outcome

Change in the SNA angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction.
Change in the SNB angle.
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction.
Change in the ANB angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction.
Change in the MM angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis.
Change in the SN-OCP angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the occlusion plane and the cranial base in the cephalometric analysis in the vertical direction.
Change in the SN-MP angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower jaw plane and the cranial base in the cephalometric analysis in the vertical direction.
Change in the SN-SPP angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper jaw plane and the cranial base in the cephalometric analysis in the vertical direction.
Change in the overbite (Ovb)
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors.
Change in the overjet (Ovj)
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient. This was measured in millimetres Horizontally from the upper to the lower central incisors.
Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees.
Change in the UI- LI angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper and the lower incisor axis in the cephalometric analysis in the anteroposterior direction.
Change in the NS-GN angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the growth pattern of the mandible in the cephalometric analysis in the vertical direction.
Change in the posterior facial height (S-Go)
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from S point to GO point.
Change in the anterior facial height (N-Me)
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from N point to Me point.
Change in the U1-Palatal plane measurement
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper central incisor apex and the palatal plane.
Change in the U6-Palatal plane measurement
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the tip of the mesial cusp of the upper first molar and the palatal plane.
Change in the L1-GoMe measurement
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the lower central incisor apex and the mandibular plane.
Change in the L6-GoMe measurement
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the tip of the mesial cusp of the lower first molar and the mandibular plane.

4 secondary outcomes

Change in the Li-Esth measurement
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the Ls-Esth measurement
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the Nasolabial angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Change in the Mentolabial angle
Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

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 20 Dec 2022.
Background: PubMed 27615261Pisani L, Bonaccorso L, Fastuca R, Spena R, Lombardo L, Caprioglio A. Systematic review for orthodontic and orthopedic treatments for anterior open bite in the mixed dentition. Prog Orthod. 2016 Dec;17(1):28. doi: 10.1186/s40510-016-0142-0. Epub 2016 Sep 19.
Background: PubMed 26846264Feres MF, Abreu LG, Insabralde NM, de Almeida MR, Flores-Mir C. Effectiveness of open bite correction when managing deleterious oral habits in growing children and adolescents: a systematic review and meta-analysis. Eur J Orthod. 2017 Feb;39(1):31-42. doi: 10.1093/ejo/cjw005. Epub 2016 Feb 3.
Background: PubMed 28488080Turkkahraman H, Cetin E. Comparison of two treatment strategies for the early treatment of an anterior skeletal open bite : Posterior bite block-vertical pull chin cup (PBB-VPC) vs. posterior bite block-high pull headgear (PBB-HPH). J Orofac Orthop. 2017 Jul;78(4):338-347. doi: 10.1007/s00056-017-0095-z. Epub 2017 May 9.
Background: PubMed 19915269Meibodi SE, Fatahi Meybodi S, Samadi AH. The effect of posterior bite-plane on dentoskeletal changes in skeletal open-bite malocclusion. J Indian Soc Pedod Prev Dent. 2009 Oct-Dec;27(4):202-4. doi: 10.4103/0970-4388.57653.
Background: PubMed 17605497Cinsar A, Alagha AR, Akyalcin S. Skeletal open bite correction with rapid molar intruder appliance in growing individuals. Angle Orthod. 2007 Jul;77(4):632-9. doi: 10.2319/071406-292.
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.

Hammam Zeidan, DDS,MSc principal investigator

Department of Orthodontics, University of Al-Baath Dental School, Hama, Syria.

Amjad A Hasan, DDS,MSc principal investigator

Department of orthodontics, Damascus University, Syria

Mohammad Y. Hajeer, DDS,MSc,PhD study director

Department of orthodontics, Damascus University, Syria

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rapid molar intruder in people with Open Bite, run by Damascus University at 1 site in Syria.

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 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: finished, as of the sponsor's last update on 20 Dec 2022. 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 Syria. 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?

Change in the SNA angle (time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.). The study lists 18 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 NCT05657522, 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 Dec 2022.