Temporomandibular Joint DisordersNCT04661670
Occlusal Stabilization Splints Equilibrated by Different Techniques and Their Effect on TMD
A study testing occlusal stabilization splints in people with Temporomandibular Joint Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
The objective of the study is to evaluate if occlusal stabilization splints equilibrated by articulating paper will have equivalent effect in comparison to occlusal stabilization splints equilibrated by T-scan regarding the relief of the TMD signs and symptoms Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- occlusal stabilization splints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 30 May 2022
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult cooperative patients who have bruxism and TMD of myogenous origin (Age: 18-60)
- Fully dentate or partial edentulous patients with no more than one missing tooth per quadrant, excluding third molars
- presence of signs and symptoms of TMD ( diffuse pain in head and neck, headache pain exaggeration by jaw movements, restricted jaw movements)
- severe Disc displacement with or without reduction who can be treated by stabilization appliance (Reciprocal click, or without click)
Who cannot join
- Use of removable dentures
- More than one absent tooth per quadrant
- Patients with anterior open bite
- Severe systemic conditions or somatic symptoms, depression and anxiety
- Trauma of recent date towards face, head or neck
- Dentoalveolar pathology or ongoing treatment related to TMD.
- patients scheduled for dental procedures that could alter the occlusion during therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Sarah Abdelsalam, Master
About this study
Official title: Relief of Signs and Symptoms in Patients With Tempro-mandibular Disorders Using Occlusal Stabilization Splints Equilibrated by T-scan Versus Articulating Paper: A Randomized Clinical Trial
The objective of the study is to evaluate if occlusal stabilization splints equilibrated by articulating paper will have equivalent effect in comparison to occlusal stabilization splints equilibrated by T-scan regarding the relief of the TMD signs and symptoms
Read the detailed description
Eligible patient will be selected from Outpatient Clinic in Prosthodontics Department clinic. Patients will be informed of the nature of the research work and informed consent will be obtained from each of them.All patients will be assessed for TMJ health following DC/TMD Axis I and II to confirm the diagnosis . Base line pain scale and range of pain free jaw movements (mm) will be recorded before starting the treatment. Patients will be randomly divided into 2 equal groups; occlusal stabilization splints equilibrated by articulating paper and occlusal stabilization splints equilibrated by T-scan
Patients of both groups will be subjected to:
Primary impressions will be taken using rubber base impression material (Zhermac zetaplus impression material) ,the impressions will be poured twice to construct 2 study casts to be used for final occlusal adjustment of the splint. Maxillary Face-bow record will be done to mount both maxillary casts on a semi adjustable articulator (A7-Plus Bio Art semi-adjustable articulator) using different mounting rings.
Bite registration using bite registration material (Futar D Bite Registration Material - Ultra Rigid from Kettenbach LP ) will be done in centric relation after deprogramming the muscles using acrylic jig or leaf gauges, followed by loading test for condyle position verification 7to mount the mandibular cast. A protrusive record will be made at 6 mm mandibular protrusion to set the horizontal condylar guidance, while lateral condylar guidance will be adjusted at fixed value of 15 degrees.
The centric relation will be verified by comparing the first point of contact intraorally and the first point of contact on the articulator will be verified. The maxillary cast will be surveyed to detect teeth height of contour. The borders of the occlusal splint will be drawn on the maxillary cast to be occlusal to the height of contour buccally and to extend 1-2 mm beyond the gingival margin on the palatal surface. As the jaw relation and mounting will be done by leaf gauges and at elevated vertical dimension, the incisal pin will be kept on zero. The appliance will be waxed up by filling the inter-arch space with pink wax placed will taper it to a feather edge to the previously drawn borders. A complete arch coverage design will be done and will be shaped to be flat. The wax will be checked with 20 um thick articulating paper (AccuFilm, parkell, USA)and should produce bilateral posterior contacts in coincidence with physiologic condylar seating and a smooth anterior guidance in excursions allowing posterior disocclusion2
A mould for the shaped wax will be done using Polyvinyl silicone elastomer putty material (elite P\&P, Italy) in a plastic container. A white self-cured acrylic resin (Acrostone cold cure material) will be mixed and filled inside the mould and will be closed tightly till all excess comes out. After material setting the acrylic occlusal splint will be finished and seated on the duplicated cast and final fit and occlusal correction using 20 um thick articulating paper (AccuFilm, parkell, USA) will be done.
In the next clinical visit the splint will be inserted inside patient's mouth and will be checked for stability and comfort before any occlusal adjustment which will be performed by articulating paper or T-Scan according to the assigned groups.
Study group:
In this group the final occlusal correction will be performed with the patient in supine position using 20 um thick articulating paper (AccuFilm, parkell, USA) and articulating foil (DENU shim stock, HDI) 8 um thick. The patient will be asked to tap 3 times on the articulating paper and occlusal correction will be done using carbide laboratory bur and rubber cone till uniform contact on all teeth is achieved in centric relation which is illustrated on the splint by a series of uniformly appearing articulating paper dots. Then the patient will be asked to make protrusive and right and left excursions to ensure smooth anterior guidance and posterior disocclusion.
Control group:
In this group the same adjustment sequence will be done using T Scan III (software version 8.0) computerized occlusal analysis, a new patient file will be opened, the patient's biological data will be entered, and the T Scan dental arch size is customized to fit the patients arch anatomy. A centric occlusion scan label with Turbo mode (0.003 second incremental scanning) scan speed will be selected. The sensor will be placed intraorally so that the midline 'V' of the support contacts the midline of the occlusal splint. The patient is then asked to gently close on their posterior teeth, then clench firmly against the occlusal splint for one to three seconds. The sensitivity level will be adjusted to fit the patient's occlusal strength. When the sensitivity is properly set, the patient will be asked to clench
to record occlusal force and areas that needs adjustment will be grinded using the paper marks as the guideline and carbide laboratory bur till bilateral force balance achieved and the center of force (COF) icon sits close to the midline.
Mandibular excursions are then adjusted in a similar fashion. The appropriate excursion scan label will be chosen, after which the patient is asked to clench on their posterior teeth for one to three seconds, and then move in a lateral or protrusive excursion to the full extent of the border movement. Contacts rather than anterior and canine guidance will be eliminated till achieving anterior guidance and posterior disocclusion in time less than 0.5 seconds.
For both groups:
After occlusal adjustment in centric relation, the occlusion will be evaluated in upright position and will ensure that patient bites comfortably and that all teeth contact evenly, with no anterior teeth contacting harder than the posterior teeth. No polishing will be done after adjustment for maintenance of the refined occlusal contacts. The patients will be instructed to wear the occlusal splint at nighttime, to alleviate daytime harmful habits, the patients will be instructed to seal the lips and separate the teeth, keeping the muscles relaxed. The patients will be recalled every after 1 week and every 2 weeks for further needed occlusal adjustment till there is no change at all between visits
After 1 month and 3 months, the patients will be recalled to evaluate the improvements in TMD pain symptoms using questionnaires, in addition to the improvement in range of pain free jaw movements using mm ruler.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- occlusal stabilization splints
- Keywords
- equilbration, T scan, Occlusal splints
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal stabilization splintsDevice
Also called Michigan splint, turner splint
an intraoral appliance that has flat surface to allow bilateral posterior contacts in coincidence with physiologic condylar seating and to produce smooth anterior guidance in excursions
| Study group | Role | What they receive |
|---|---|---|
| occlusal stabilization splints equilibrated by articulating paper | Active comparator | In this group the final occlusal correction will be performed with the patient in supine position using 20 um thick articulating paper and articulating foil 8 um thick. The patient will be asked to tap 3 times on the articulating paper and occlusal correction will be done using carbide laboratory bur and rubber cone till uniform contact on all teeth is achieved in centric relation which is illustrated on the splint by a series of uniformly appearing articulating paper dots. Then the patient will be asked to make protrusive and right and left excursions to ensure smooth anterior guidance and posterior disocclusion. Receives: Device: occlusal stabilization splints |
| occlusal stabilization splints equilibrated by T-scan | Active comparator | In this group the same adjustment sequence will be done using T Scan III (software version 8.0) computerized occlusal analysis, a new patient file will be opened, the patient's biological data will be entered, and the T Scan dental arch size is customized to fit the patients arch anatomy. The patient will be asked to clench to record occlusal force and areas that needs adjustment will be grinded using the paper marks as the guideline and carbide laboratory bur till bilateral force balance achieved and the center of force (COF) icon sits close to the midline.
Mandibular excursions are then adjusted in a similar fashion. Contacts rather than anterior and canine guidance will be eliminated till achieving anterior guidance and posterior disocclusion in time less than 0.5 seconds. Receives: Device: occlusal stabilization splints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of TMD Signs and symptoms
Graded pain scale questionnaire (VAS scale)
Measured: 3 months
Increased range of painless jaw movements
Jaw functional questionnaire (VAS scale)
Measured: 3 months
Secondary outcomes (1)
measurement of range of jaw movements (maximum un assisted opening , protruion, right and left excrusion)
ruler measurement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 May 2021
- Primary completion20 Feb 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Sara Eman Saad el Din, Cairo University
- Investigators
- Ashraf emil, PhD, Study director, Cairo UniversityMohamed Khashab, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661670
- Sponsor's protocol ID
- PRO341
- Status last verified
- Jul 2021
- First submitted
- 1 Dec 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient1s contact and pre and post data about pain level and jaw movements
Publications
Kerstein RB, Radke J. Clinician accuracy when subjectively interpreting articulating paper markings. Cranio. 2014 Jan;32(1):13-23. doi: 10.1179/0886963413Z.0000000001.
PubMed 24660642Garrido Garcia VC, Garcia Cartagena A, Gonzalez Sequeros O. Evaluation of occlusal contacts in maximum intercuspation using the T-Scan system. J Oral Rehabil. 1997 Dec;24(12):899-903. doi: 10.1046/j.1365-2842.1997.00586.x.
PubMed 9467991
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relief of Signs and Symptoms in Patients With Tempro-mandibular Disorders Using Occlusal Stabilization Splints Equilibrated by T-scan Versus Articulating Paper: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04661670
- Acronym / sponsor ID
- PRO341
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- equilbration, T scan, Occlusal splints
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 May 2021 (actual)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate if occlusal stabilization splints equilibrated by articulating paper will have equivalent effect in comparison to occlusal stabilization splints equilibrated by T-scan regarding the relief of the TMD signs and symptoms
Detailed description
Eligible patient will be selected from Outpatient Clinic in Prosthodontics Department clinic. Patients will be informed of the nature of the research work and informed consent will be obtained from each of them.All patients will be assessed for TMJ health following DC/TMD Axis I and II to confirm the diagnosis . Base line pain scale and range of pain free jaw movements (mm) will be recorded before starting the treatment. Patients will be randomly divided into 2 equal groups; occlusal stabilization splints equilibrated by articulating paper and occlusal stabilization splints equilibrated by T-scan
Patients of both groups will be subjected to:
Primary impressions will be taken using rubber base impression material (Zhermac zetaplus impression material) ,the impressions will be poured twice to construct 2 study casts to be used for final occlusal adjustment of the splint. Maxillary Face-bow record will be done to mount both maxillary casts on a semi adjustable articulator (A7-Plus Bio Art semi-adjustable articulator) using different mounting rings.
Bite registration using bite registration material (Futar D Bite Registration Material - Ultra Rigid from Kettenbach LP ) will be done in centric relation after deprogramming the muscles using acrylic jig or leaf gauges, followed by loading test for condyle position verification 7to mount the mandibular cast. A protrusive record will be made at 6 mm mandibular protrusion to set the horizontal condylar guidance, while lateral condylar guidance will be adjusted at fixed value of 15 degrees.
The centric relation will be verified by comparing the first point of contact intraorally and the first point of contact on the articulator will be verified. The maxillary cast will be surveyed to detect teeth height of contour. The borders of the occlusal splint will be drawn on the maxillary cast to be occlusal to the height of contour buccally and to extend 1-2 mm beyond the gingival margin on the palatal surface. As the jaw relation and mounting will be done by leaf gauges and at elevated vertical dimension, the incisal pin will be kept on zero. The appliance will be waxed up by filling the inter-arch space with pink wax placed will taper it to a feather edge to the previously drawn borders. A complete arch coverage design will be done and will be shaped to be flat. The wax will be checked with 20 um thick articulating paper (AccuFilm, parkell, USA)and should produce bilateral posterior contacts in coincidence with physiologic condylar seating and a smooth anterior guidance in excursions allowing posterior disocclusion2
A mould for the shaped wax will be done using Polyvinyl silicone elastomer putty material (elite P\&P, Italy) in a plastic container. A white self-cured acrylic resin (Acrostone cold cure material) will be mixed and filled inside the mould and will be closed tightly till all excess comes out. After material setting the acrylic occlusal splint will be finished and seated on the duplicated cast and final fit and occlusal correction using 20 um thick articulating paper (AccuFilm, parkell, USA) will be done.
In the next clinical visit the splint will be inserted inside patient's mouth and will be checked for stability and comfort before any occlusal adjustment which will be performed by articulating paper or T-Scan according to the assigned groups.
Study group:
In this group the final occlusal correction will be performed with the patient in supine position using 20 um thick articulating paper (AccuFilm, parkell, USA) and articulating foil (DENU shim stock, HDI) 8 um thick. The patient will be asked to tap 3 times on the articulating paper and occlusal correction will be done using carbide laboratory bur and rubber cone till uniform contact on all teeth is achieved in centric relation which is illustrated on the splint by a series of uniformly appearing articulating paper dots. Then the patient will be asked to make protrusive and right and left excursions to ensure smooth anterior guidance and posterior disocclusion.
Control group:
In this group the same adjustment sequence will be done using T Scan III (software version 8.0) computerized occlusal analysis, a new patient file will be opened, the patient's biological data will be entered, and the T Scan dental arch size is customized to fit the patients arch anatomy. A centric occlusion scan label with Turbo mode (0.003 second incremental scanning) scan speed will be selected. The sensor will be placed intraorally so that the midline 'V' of the support contacts the midline of the occlusal splint. The patient is then asked to gently close on their posterior teeth, then clench firmly against the occlusal splint for one to three seconds. The sensitivity level will be adjusted to fit the patient's occlusal strength. When the sensitivity is properly set, the patient will be asked to clench
to record occlusal force and areas that needs adjustment will be grinded using the paper marks as the guideline and carbide laboratory bur till bilateral force balance achieved and the center of force (COF) icon sits close to the midline.
Mandibular excursions are then adjusted in a similar fashion. The appropriate excursion scan label will be chosen, after which the patient is asked to clench on their posterior teeth for one to three seconds, and then move in a lateral or protrusive excursion to the full extent of the border movement. Contacts rather than anterior and canine guidance will be eliminated till achieving anterior guidance and posterior disocclusion in time less than 0.5 seconds.
For both groups:
After occlusal adjustment in centric relation, the occlusion will be evaluated in upright position and will ensure that patient bites comfortably and that all teeth contact evenly, with no anterior teeth contacting harder than the posterior teeth. No polishing will be done after adjustment for maintenance of the refined occlusal contacts. The patients will be instructed to wear the occlusal splint at nighttime, to alleviate daytime harmful habits, the patients will be instructed to seal the lips and separate the teeth, keeping the muscles relaxed. The patients will be recalled every after 1 week and every 2 weeks for further needed occlusal adjustment till there is no change at all between visits
After 1 month and 3 months, the patients will be recalled to evaluate the improvements in TMD pain symptoms using questionnaires, in addition to the improvement in range of pain free jaw movements using mm ruler.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| occlusal stabilization splints equilibrated by articulating paper | Active comparator | Device: occlusal stabilization splintsIn this group the final occlusal correction will be performed with the patient in supine position using 20 um thick articulating paper and articulating foil 8 um thick. The patient will be asked to tap 3 times on the articulating paper and occlusal correction will be done using carbide laboratory bur and rubber cone till uniform contact on all teeth is achieved in centric relation which is illustrated on the splint by a series of uniformly appearing articulating paper dots. Then the patient will be asked to make protrusive and right and left excursions to ensure smooth anterior guidance and posterior disocclusion. |
| occlusal stabilization splints equilibrated by T-scan | Active comparator | Device: occlusal stabilization splintsIn this group the same adjustment sequence will be done using T Scan III (software version 8.0) computerized occlusal analysis, a new patient file will be opened, the patient's biological data will be entered, and the T Scan dental arch size is customized to fit the patients arch anatomy. The patient will be asked to clench to record occlusal force and areas that needs adjustment will be grinded using the paper marks as the guideline and carbide laboratory bur till bilateral force balance achieved and the center of force (COF) icon sits close to the midline. Mandibular excursions are then adjusted in a similar fashion. Contacts rather than anterior and canine guidance will be eliminated till achieving anterior guidance and posterior disocclusion in time less than 0.5 seconds. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult cooperative patients who have bruxism and TMD of myogenous origin (Age: 18-60)
- Fully dentate or partial edentulous patients with no more than one missing tooth per quadrant, excluding third molars
- presence of signs and symptoms of TMD ( diffuse pain in head and neck, headache pain exaggeration by jaw movements, restricted jaw movements)
- severe Disc displacement with or without reduction who can be treated by stabilization appliance (Reciprocal click, or without click)
Key exclusion criteria (7 listed)
- Use of removable dentures
- More than one absent tooth per quadrant
- Patients with anterior open bite
- Severe systemic conditions or somatic symptoms, depression and anxiety
- Trauma of recent date towards face, head or neck
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 stabilization splintsAlso: Michigan splint, turner splintan intraoral appliance that has flat surface to allow bilateral posterior contacts in coincidence with physiologic condylar seating and to produce smooth anterior guidance in excursions | Device | occlusal stabilization splints equilibrated by T-scan, occlusal stabilization splints equilibrated by articulating paper |
Primary outcome
Relief of TMD Signs and symptoms
Time frame: 3 months
Graded pain scale questionnaire (VAS scale)
Increased range of painless jaw movements
Time frame: 3 months
Jaw functional questionnaire (VAS scale)
1 secondary outcome
measurement of range of jaw movements (maximum un assisted opening , protruion, right and left excrusion)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Background: PubMed 24660642Kerstein RB, Radke J. Clinician accuracy when subjectively interpreting articulating paper markings. Cranio. 2014 Jan;32(1):13-23. doi: 10.1179/0886963413Z.0000000001.
- Background: PubMed 9467991Garrido Garcia VC, Garcia Cartagena A, Gonzalez Sequeros O. Evaluation of occlusal contacts in maximum intercuspation using the T-Scan system. J Oral Rehabil. 1997 Dec;24(12):899-903. doi: 10.1046/j.1365-2842.1997.00586.x.
- Individual participant dataSharing planned: Yes. Patient1s contact and pre and post data about pain level and jaw movements
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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.
Ashraf emil, PhD study director
Cairo University
Mohamed Khashab, PhD study director
Cairo University
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 stabilization splints in people with Temporomandibular Joint Disorders, run by Cairo University at 1 site in Egypt.
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 7 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 2 Aug 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara Abd el salam, Master (+201033220667, sara.eman@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of TMD Signs and symptoms (time frame: 3 months). 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 NCT04661670, which also lists 2 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 2 Aug 2021.