Bone DensityNCT04189718

Comparative Evaluation of Osseodensification Versus Conventional Implant Site

A study testing osseodensification protocol and conventional implant site preparation protocol in people with Bone Density and Implant Stability, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.

Completed

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

Official record

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Trial summary

The present study is a human, prospective, randomised controlled clinical trial conducted to explore and compare the clinical and radiological outcome of Osseodensification protocol with conventional implant site preparation protocol. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Bone Density, Implant Stability
What is being tested?: osseodensification protocol and conventional implant site preparation protocol
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteIndia
Study dates: 30 Nov 2017to 30 Oct 2019
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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Single/multiple missing teeth in the maxillary anterior/posterior region.
Bone density of D2 or D3 (Carl E.Misch).
Patients between 18-75 years.
Patients who demonstrate good plaque control (PI<10%) and showing good compliance.
Patients willing to participate in the study.

Who cannot join

Insufficient density or height of residual ridge.
Patients with bleeding disorder or on anticoagulant therapy.
Pregnant and lactating females.
Patients with history of smoking.
Use of systemic antibiotics in the past 3 months.
Patients treated with any medication known to cause periodontal changes.

Show all 12Show fewer

Drug and alcohol abuse.
Occlusal interferences.
Patients with history of titanium allergy.
Immunocompromised state and debilitating disease.
Malignancy or radiotherapy/chemotherapy for malignancy.
Systemic diseases that would negatively influence wound healing.

Trial locations and contacts

1 site in 1 country.

India1 site

Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157

Other trials in India

About this study

Official title: A Clinical and Radiological Comparison of Osseodensification Versus Conventional Implant Site Preparation Protocol During Dental Implant Placement. A Randomised Controlled Clinical Trial

Read the detailed description

Twenty two dental implants were placed in twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients.

All the patients received Norris implant. the implant site preparation technique being Osseodensification protocol for the test group and conventional implant site preparation protocol for the control group, eleven in each group. The clinical and radiographic parameters were recorded at baseline, immediate post implant placement, six months and twelve months postoperatively.

Conditions: Bone Density, Implant Stability
Being tested: osseodensification protocol, conventional implant site preparation protocol
Keywords: hounsfield

What participants receive

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

osseodensification protocolProcedure or surgery
Also called Densah bur protocol, Osseodensification technique
Local anaesthesia was administered and mucoperiosteal flap was reflected. Implant osteotomies was performed with sequential drilling with osseodensification protocol at 1100 rpm. The pilot drill was used in clockwise direction and the other sequential drills were used in counter clockwise direction under copious irrigation. Flap closure was achieved using 3-0 silk sutures to protect the implant site.
conventional implant site preparation protocolProcedure or surgery
Also called standard drilling technique, regular drilling technique
Local anaesthesia was administered and mucoperiosteal flap was reflected. Implant osteotomies was performed with sequential drilling with conventional implant site preparation protocol at 1100 rpm. The pilot drill was used in clockwise direction and the other sequential drills were used in clockwise direction under copious irrigation. Flap closure was achieved using 3-0 silk sutures to protect the implant site.

Study groups in NCT04189718
Study group	Role	What they receive
osseodensification protocol	Experimental	Experimental: In the test group, osteotomy site preparation was performed using Osseodensification technique at 1100 rpm and implant was placed Receives: Procedure: osseodensification protocol; Procedure: conventional implant site preparation protocol
conventional implant site preparation protocol	Active comparator	Control: in the control group, osteotomy site was prepared using conventional drilling protocol at 1100 rpm and implant was placed. Receives: Procedure: osseodensification protocol; Procedure: conventional implant site preparation protocol

What is being measured

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

primary implant stability
the primary implant stability was measured during implant placement using Insertion Torque Value(ITV).
Measured: immediate post implant placement
change from baseline in bone density
A Multislice CT was used for scanning the implant site pre operatively, just after implant placement and 1 year post implant placement to measure the change in bone density. It was performed using a tube voltage of 120 kV(kilovolt) and a tube current of 40 mA(milliampere). The occlusal plane of the patient was set perpendicular to the floor base using ear rods. The axial images was reconstructed with 0.625 mm thick slices at 0.625 mm interval and a 1.75 mm field of view(FOV) image analysis software
Measured: 1 year
change from baseline in crestal bone level
Digital radiographs (radiovisiograph-RVG) were standardised using radiographic paralleling technique and positioning device and custom fabricated bite-block at baseline and follow up.Mesial and distal peri-implant radiographic bone level were recorded in millimetres on the digital radiographs using Digimiser image
Measured: 1 year

Secondary outcomes (3)

change from baseline in keratinized mucosa width
The width of keratinized mucosa was measured from the mucosal margin to the mucogingival junction at the facial surface. The mucogingival junction location was determined using a visual method (Schiller's potassium iodide solution).
Measured: 1 year
change from baseline in ridge width
Soft tissue and hard tissue labio-lingual ridge width was measured at baseline, immediate post implant placement, 6 months and 1 year after implant placement using ridge mapping calipers/Multislice CT.
Measured: 1 year
Patient reported pain evaluation (Visual Analog Scale)
patient were asked to report the pain after the procedure in terms of visual analog scale (VAS) score in a rating between 1 to 10. There are 5-point verbal descriptive scale with an interval of 2("nil," "mild," "moderate," "severe," and "very severe") Patients were asked to rate their pain in a score between 1-10
Measured: 1 year

Timeline

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

30 Nov 201730 Oct 2019

First posted6 Dec 2019
Study start30 Nov 2017
Primary completion15 Oct 2019
Study completion30 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Bone DensityStudies 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
Model description: wo groups were made one test and control. The control group were treated with conventional implant site preparation technique and the test group were treated with osseodensification technique.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04189718
Sponsor's protocol ID: 02_D012_80824
Status last verified: Dec 2019
First submitted: 2 Dec 2019
Last updated: 6 Dec 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.
PubMed 26584202
Lahens B, Neiva R, Tovar N, Alifarag AM, Jimbo R, Bonfante EA, Bowers MM, Cuppini M, Freitas H, Witek L, Coelho PG. Biomechanical and histologic basis of osseodensification drilling for endosteal implant placement in low density bone. An experimental study in sheep. J Mech Behav Biomed Mater. 2016 Oct;63:56-65. doi: 10.1016/j.jmbbm.2016.06.007. Epub 2016 Jun 10.
PubMed 27341291
Lahens B, Lopez CD, Neiva RF, Bowers MM, Jimbo R, Bonfante EA, Morcos J, Witek L, Tovar N, Coelho PG. The effect of osseodensification drilling for endosteal implants with different surface treatments: A study in sheep. J Biomed Mater Res B Appl Biomater. 2019 Apr;107(3):615-623. doi: 10.1002/jbm.b.34154. Epub 2018 Aug 6.
PubMed 30080320
Witek L, Neiva R, Alifarag A, Shahraki F, Sayah G, Tovar N, Lopez CD, Gil L, Coelho PG. Absence of Healing Impairment in Osteotomies Prepared via Osseodensification Drilling. Int J Periodontics Restorative Dent. 2019 Jan/Feb;39(1):65-71. doi: 10.11607/prd.3504.
PubMed 30543729
Witek L, Alifarag AM, Tovar N, Lopez CD, Gil LF, Gorbonosov M, Hannan K, Neiva R, Coelho PG. Osteogenic parameters surrounding trabecular tantalum metal implants in osteotomies prepared via osseodensification drilling. Med Oral Patol Oral Cir Bucal. 2019 Nov 1;24(6):e764-e769. doi: 10.4317/medoral.23108.
PubMed 31655837
Alifarag AM, Lopez CD, Neiva RF, Tovar N, Witek L, Coelho PG. Atemporal osseointegration: Early biomechanical stability through osseodensification. J Orthop Res. 2018 Sep;36(9):2516-2523. doi: 10.1002/jor.23893. Epub 2018 Mar 30.
PubMed 29537128
Tian JH, Neiva R, Coelho PG, Witek L, Tovar NM, Lo IC, Gil LF, Torroni A. Alveolar Ridge Expansion: Comparison of Osseodensification and Conventional Osteotome Techniques. J Craniofac Surg. 2019 Mar/Apr;30(2):607-610. doi: 10.1097/SCS.0000000000004956.
PubMed 30507887
Lopez CD, Alifarag AM, Torroni A, Tovar N, Diaz-Siso JR, Witek L, Rodriguez ED, Coelho PG. Osseodensification for enhancement of spinal surgical hardware fixation. J Mech Behav Biomed Mater. 2017 May;69:275-281. doi: 10.1016/j.jmbbm.2017.01.020. Epub 2017 Jan 13.
PubMed 28113132
Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
PubMed 27741329
Stavropoulos A, Cochran D, Obrecht M, Pippenger BE, Dard M. Effect of Osteotomy Preparation on Osseointegration of Immediately Loaded, Tapered Dental Implants. Adv Dent Res. 2016 Mar;28(1):34-41. doi: 10.1177/0022034515624446.
PubMed 26927486
Almutairi AS, Walid MA, Alkhodary MA. The effect of osseodensification and different thread designs on the dental implant primary stability. F1000Res. 2018 Dec 5;7:1898. doi: 10.12688/f1000research.17292.1. eCollection 2018.
PubMed 31131085
Oliveira PGFP, Bergamo ETP, Neiva R, Bonfante EA, Witek L, Tovar N, Coelho PG. Osseodensification outperforms conventional implant subtractive instrumentation: A study in sheep. Mater Sci Eng C Mater Biol Appl. 2018 Sep 1;90:300-307. doi: 10.1016/j.msec.2018.04.051. Epub 2018 Apr 18. No abstract available.
PubMed 29853095
Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. Validation of value of actual micromotion as a direct measure of implant micromobility after healing (secondary implant stability). An in vivo histologic and biomechanical study. Clin Oral Implants Res. 2016 Nov;27(11):1423-1430. doi: 10.1111/clr.12756. Epub 2016 Jan 4.
PubMed 26727557
Falco A, Berardini M, Trisi P. Correlation Between Implant Geometry, Implant Surface, Insertion Torque, and Primary Stability: In Vitro Biomechanical Analysis. Int J Oral Maxillofac Implants. 2018 Jul/Aug;33(4):824-830. doi: 10.11607/jomi.6285.
PubMed 30024998
Slete FB, Olin P, Prasad H. Histomorphometric Comparison of 3 Osteotomy Techniques. Implant Dent. 2018 Aug;27(4):424-428. doi: 10.1097/ID.0000000000000767.
PubMed 29762184

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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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical and Radiological Comparison of Osseodensification Versus Conventional Implant Site Preparation Protocol During Dental Implant Placement. A Randomised Controlled Clinical Trial
ClinicalTrials.gov ID: NCT04189718
Acronym / sponsor ID: 02_D012_80824
Conditions: Bone Density, Implant Stability
Keywords: hounsfield
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
Study start: 30 Nov 2017 (actual)
Primary completion: 15 Oct 2019 (actual)
Study completion: 30 Oct 2019 (actual)
First posted: 6 Dec 2019 (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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: wo groups were made one test and control. The control group were treated with conventional implant site preparation technique and the test group were treated with osseodensification technique.

Arm	Type	Receives
osseodensification protocol	Experimental	Procedure: osseodensification protocol, Procedure: conventional implant site preparation protocolExperimental: In the test group, osteotomy site preparation was performed using Osseodensification technique at 1100 rpm and implant was placed
conventional implant site preparation protocol	Active comparator	Procedure: osseodensification protocol, Procedure: conventional implant site preparation protocolControl: in the control group, osteotomy site was prepared using conventional drilling protocol at 1100 rpm and implant was placed.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Single/multiple missing teeth in the maxillary anterior/posterior region.
Bone density of D2 or D3 (Carl E.Misch).
Patients between 18-75 years.
Patients who demonstrate good plaque control (PI<10%) and showing good compliance.
Patients willing to participate in the study.

Key exclusion criteria (12 listed)

Insufficient density or height of residual ridge.
Patients with bleeding disorder or on anticoagulant therapy.
Pregnant and lactating females.
Patients with history of smoking.
Use of systemic antibiotics in the past 3 months.

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
osseodensification protocolAlso: Densah bur protocol, Osseodensification techniqueLocal anaesthesia was administered and mucoperiosteal flap was reflected. Implant osteotomies was performed with sequential drilling with osseodensification protocol at 1100 rpm. The pilot drill was used in clockwise direction and the other sequential drills were used in counter clockwise direction under copious irrigation. Flap closure was achieved using 3-0 silk sutures to protect the implant site.	Procedure or surgery	conventional implant site preparation protocol, osseodensification protocol
conventional implant site preparation protocolAlso: standard drilling technique, regular drilling techniqueLocal anaesthesia was administered and mucoperiosteal flap was reflected. Implant osteotomies was performed with sequential drilling with conventional implant site preparation protocol at 1100 rpm. The pilot drill was used in clockwise direction and the other sequential drills were used in clockwise direction under copious irrigation. Flap closure was achieved using 3-0 silk sutures to protect the implant site.	Procedure or surgery	conventional implant site preparation protocol, osseodensification protocol

Primary outcome

primary implant stability
Time frame: immediate post implant placement
the primary implant stability was measured during implant placement using Insertion Torque Value(ITV).
change from baseline in bone density
Time frame: 1 year
A Multislice CT was used for scanning the implant site pre operatively, just after implant placement and 1 year post implant placement to measure the change in bone density. It was performed using a tube voltage of 120 kV(kilovolt) and a tube current of 40 mA(milliampere). The occlusal plane of the patient was set perpendicular to the floor base using ear rods. The axial images was reconstructed with 0.625 mm thick slices at 0.625 mm interval and a 1.75 mm field of view(FOV) image analysis software
change from baseline in crestal bone level
Time frame: 1 year
Digital radiographs (radiovisiograph-RVG) were standardised using radiographic paralleling technique and positioning device and custom fabricated bite-block at baseline and follow up.Mesial and distal peri-implant radiographic bone level were recorded in millimetres on the digital radiographs using Digimiser image

3 secondary outcomes

change from baseline in keratinized mucosa width
Time frame: 1 year
change from baseline in ridge width
Time frame: 1 year
Patient reported pain evaluation (Visual Analog Scale)
Time frame: 1 year

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 6 Dec 2019.
Results publication: PubMed 26584202Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.
Results publication: PubMed 27341291Lahens B, Neiva R, Tovar N, Alifarag AM, Jimbo R, Bonfante EA, Bowers MM, Cuppini M, Freitas H, Witek L, Coelho PG. Biomechanical and histologic basis of osseodensification drilling for endosteal implant placement in low density bone. An experimental study in sheep. J Mech Behav Biomed Mater. 2016 Oct;63:56-65. doi: 10.1016/j.jmbbm.2016.06.007. Epub 2016 Jun 10.
Results publication: PubMed 30080320Lahens B, Lopez CD, Neiva RF, Bowers MM, Jimbo R, Bonfante EA, Morcos J, Witek L, Tovar N, Coelho PG. The effect of osseodensification drilling for endosteal implants with different surface treatments: A study in sheep. J Biomed Mater Res B Appl Biomater. 2019 Apr;107(3):615-623. doi: 10.1002/jbm.b.34154. Epub 2018 Aug 6.
Results publication: PubMed 30543729Witek L, Neiva R, Alifarag A, Shahraki F, Sayah G, Tovar N, Lopez CD, Gil L, Coelho PG. Absence of Healing Impairment in Osteotomies Prepared via Osseodensification Drilling. Int J Periodontics Restorative Dent. 2019 Jan/Feb;39(1):65-71. doi: 10.11607/prd.3504.
Results publication: PubMed 31655837Witek L, Alifarag AM, Tovar N, Lopez CD, Gil LF, Gorbonosov M, Hannan K, Neiva R, Coelho PG. Osteogenic parameters surrounding trabecular tantalum metal implants in osteotomies prepared via osseodensification drilling. Med Oral Patol Oral Cir Bucal. 2019 Nov 1;24(6):e764-e769. doi: 10.4317/medoral.23108.
Results publication: PubMed 29537128Alifarag AM, Lopez CD, Neiva RF, Tovar N, Witek L, Coelho PG. Atemporal osseointegration: Early biomechanical stability through osseodensification. J Orthop Res. 2018 Sep;36(9):2516-2523. doi: 10.1002/jor.23893. Epub 2018 Mar 30.
Results publication: PubMed 30507887Tian JH, Neiva R, Coelho PG, Witek L, Tovar NM, Lo IC, Gil LF, Torroni A. Alveolar Ridge Expansion: Comparison of Osseodensification and Conventional Osteotome Techniques. J Craniofac Surg. 2019 Mar/Apr;30(2):607-610. doi: 10.1097/SCS.0000000000004956.
Results publication: PubMed 28113132Lopez CD, Alifarag AM, Torroni A, Tovar N, Diaz-Siso JR, Witek L, Rodriguez ED, Coelho PG. Osseodensification for enhancement of spinal surgical hardware fixation. J Mech Behav Biomed Mater. 2017 May;69:275-281. doi: 10.1016/j.jmbbm.2017.01.020. Epub 2017 Jan 13.
Results publication: PubMed 27741329Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
Results publication: PubMed 26927486Stavropoulos A, Cochran D, Obrecht M, Pippenger BE, Dard M. Effect of Osteotomy Preparation on Osseointegration of Immediately Loaded, Tapered Dental Implants. Adv Dent Res. 2016 Mar;28(1):34-41. doi: 10.1177/0022034515624446.
Results publication: PubMed 31131085Almutairi AS, Walid MA, Alkhodary MA. The effect of osseodensification and different thread designs on the dental implant primary stability. F1000Res. 2018 Dec 5;7:1898. doi: 10.12688/f1000research.17292.1. eCollection 2018.
Results publication: PubMed 29853095Oliveira PGFP, Bergamo ETP, Neiva R, Bonfante EA, Witek L, Tovar N, Coelho PG. Osseodensification outperforms conventional implant subtractive instrumentation: A study in sheep. Mater Sci Eng C Mater Biol Appl. 2018 Sep 1;90:300-307. doi: 10.1016/j.msec.2018.04.051. Epub 2018 Apr 18. No abstract available.
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.

PRIYANKA ACHARYA, mds principal investigator

Rajiv Gandhi University of Health Sciences

prabhuji mlv, mds study director

Rajiv Gandhi University of Health Sciences

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

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 12 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 6 Dec 2019. 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 India. 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?

primary implant stability (time frame: immediate post implant placement). The study lists 3 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 NCT04189718, which also lists 18 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 6 Dec 2019.