Class II Division 1 MalocclusionNCT05335824
The Effect of Autologous Platelet Concentrations on Orthodontic Treatment Time
A study testing The platelet-rich plasma (PRP) and The injectable platelet-rich fibrin (I-PRF) group in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.
Trial summary
60 patients needed therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines were divided to randomly three groups: (1) PRP group: Received PRP injections, (2) I-PRF group: Received I-PRF injections, (3) Control group: conventional treatment with no injections. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- The platelet-rich plasma (PRP) and The injectable platelet-rich fibrin (I-PRF) group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSyria
- Study dates
- 8 Feb 2019to 25 Dec 2020
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- both male and female subjects
- 18-25 years old
- Class II Division 1 malocclusion, treated with extraction of the maxillary first premolars
- Full permanent dentition
- Good general and oral health
Who cannot join
- extreme skeletal class II malocclusion, overjet > 10 mm ANB>7◦
- diseases and medications that were likely to affect bone biology
- poor oral hygiene
- previous orthodontic treatment
- smoking
- coagulation disorders, or being treated with anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between The Effect of Platelet Rich Plasma (PRP) and Injectable Platelet Rich Fibrin (I-PRF) on Orthodontic Tooth Movement
60 patients needed therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines were divided to randomly three groups:
(1) PRP group: Received PRP injections, (2) I-PRF group: Received I-PRF injections, (3) Control group: conventional treatment with no injections. TPAs were used as an anchor unit. Coil springs were used to distalize the upper canines on 0.019 x 0.025-inch stainless archwires. Alginate impressions and dental casts of the maxillary arch were done at five-time points over a 4-month follow-up period. The amount of canine movement, canine rotation, and anchorage loss were measured on three-dimensional digital models superimposed on the rugae area.
Read the detailed description
One of the most important goals of orthodontic treatment is to decrease the treatment time via achieving faster tooth movement chiefly in adults. Adults have more bone density and less bone turnover than adolescence, which may be linked to potential root resorption, periodontal problems, and white spot lesions.
Approaches to reduce orthodontic treatment time included surgical and non-surgical techniques. Non-surgical approaches such as systemic and local administration of chemical substances, low-level laser therapy, vibrations, and pulsed electrical stimulation therapy still need more studies to determine their safety and effectiveness.
Surgical procedures such as corticotomy, corticision, and micro-osteoperforations have
, in general high success rates, but they rely on incurring an injury to bone tissues. The latter has been linked to the regional acceleratory phenomenon (RAP). But the invasive nature of these procedures, associated risks of loss of alveolar bone and gingival recession, and the help needed from another specialist limit its routine application. Recently, the possibility of using platelet-based preparations from the patient's blood to accelerate orthodontic tooth movement like platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) has grown. PRF represents the second generation of biological materials derived from blood. It is obtained through a centrifuge of the patient's blood without adding any additives to the tube. The variety of growth factors in PRP and PRF may have the ability to stimulate the activation of osteoblasts and osteoclasts together, which supports the idea that PRP could affect orthodontic tooth movement The study sample consisted of 60 patients and was calculated using (G-power sample size calculator), depending on the rate of canine retraction with a study power of 90%.
After ensuring the patient's compliance with the terms and conditions of this study, the purpose and methods of the study were explained to the patients using Information Sheet. In case of approval to participate, the patients were asked to sign the informed consent. Extra \& Intra-oral photographs, impressions and clinical examinations were made.
Canine retraction was initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- The platelet-rich plasma (PRP), The injectable platelet-rich fibrin (I-PRF) group, The control group
- Keywords
- Platelet-rich plasma, Platelet-rich fibrin, Acceleration
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The platelet-rich plasma (PRP)Other
Twenty ml of venous blood was drawn from each patient with the use of PRP tubes that contain anticoagulant citrate dextrose. The double-spin technique was used to prepare the PRP. The injection areas were anesthetized with lidocaine 2% with epinephrine 1/80000 and left for 10 minutes. 15 units (0. 15 mL) of PRP were injected interaligamentlly in the middle, distobuccal, and distopalatal areas of the distal surface of the upper canines (5 units in each area) together with submucosal injections buccally and palatally (100 units and 50 units
, respectively).
The injectable platelet-rich fibrin (I-PRF) groupOther
Twenty ml of venous blood was drawn from each patient in this experimental group.
I-PRF was prepared with the use of 20 ml of blood drawn from the patient in dry sterile tubes without anticoagulant (quickly before coagulation starts) by following the centrifugation protocol requires one cycle only (700 RPM for 3 minutes) Injection procedures, sites, and time were similar to the PRP group.
The control groupDevice
NiTi closed-coil springs (American Orthodontics, Sheboygan, WI) were used to impose 150 g force from the first molar band hook to the bracket of canine on each side on 0.019*0.025-in SS archwire Patients' follow-up appointments were two weeks intervals; at each visit, the force produced by the coil was checked and readjusted when needed in order to keep it at 150-g level and the appliances were examined for any deformation or change in the position because of chewing. Canine retraction continued until achieving Class I canine relationship.
| Study group | Role | What they receive |
|---|---|---|
| The platelet-rich plasma (PRP) group: | Experimental | The patients in this group received PRP injections immediately before the canine retraction, and after 8 weeks of the onset of retraction Receives: Other: The platelet-rich plasma (PRP) |
| The injectable platelet-rich fibrin (I-PRF) group | Experimental | The patients in this group received I-PRF injections immediately before the canine retraction, and after 8 weeks of the onset of retraction Receives: Other: The injectable platelet-rich fibrin (I-PRF) group |
| The control group | Active comparator | The patients in this group did not receive any injections Receives: Device: The control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in canine retraction rate
The amount of canine retraction per month was calculated by measuring the distance from the canine cusp tip in the baseline model to the canine cusp tip in the next superimposed model. The amount of distance being retracted in millimeters was divided to the duration of retraction in months to give an estimation of the retraction rate.
Measured: The estimation took place at five time points: the beginning of tooth movement (T0) and at 4, 8, 12, and 16 weeks following T0
Secondary outcomes (2)
Change in the maxillary first molar position (anchorage loss)
Anchorage loss was calculated in the superimposed digital models from the mesial central fossa of a maxillary first molar of the baseline model the mesial central fossa of maxillary first molar in the next superimposed model.
Measured: T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction
Change in canine rotation
The amount of canine rotation was measured in superimposed digital models. Mesial and distal contact points of the canines were used to make a horizontal line that would make an angle with the similar line in the next superimposed model, this angle referred to the amount of canine rotation between the two superimposed models.
Measured: T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start8 Feb 2019
- Primary completion12 May 2019
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Class II Division 1 MalocclusionStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Collaborators
- Hama University
- Responsible party
- Sponsor
- Investigators
- Ali Ammar, DDS, MSc, Principal investigator, Department of orthodontics, Hama University, SyriaRabab al-Sabbagh, DDS,MSc,PhD, Study director, Department of orthodontics, Hama University, SyriaMohammad Y Hajeer, DDS,MSc,PhD, Study director, Department of orthodontics, Damascus University, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335824
- Sponsor's protocol ID
- UHDS-Ortho-07-2022
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rashid A, ElSharaby FA, Nassef EM, Mehanni S, Mostafa YA. Effect of platelet-rich plasma on orthodontic tooth movement in dogs. Orthod Craniofac Res. 2017 May;20(2):102-110. doi: 10.1111/ocr.12146.
PubMed 28414871Tehranchi A, Behnia H, Pourdanesh F, Behnia P, Pinto N, Younessian F. The effect of autologous leukocyte platelet rich fibrin on the rate of orthodontic tooth movement: A prospective randomized clinical trial. Eur J Dent. 2018 Jul-Sep;12(3):350-357. doi: 10.4103/ejd.ejd_424_17.
PubMed 30147398Reyes Pacheco AA, Collins JR, Contreras N, Lantigua A, Pithon MM, Tanaka OM. Distalization rate of maxillary canines in an alveolus filled with leukocyte-platelet-rich fibrin in adults: A randomized controlled clinical split-mouth trial. Am J Orthod Dentofacial Orthop. 2020 Aug;158(2):182-191. doi: 10.1016/j.ajodo.2020.03.020. Epub 2020 Jun 24.
PubMed 32591274Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
PubMed 33481053Ali Mahmood TM, Chawshli OF. The Effect of Submucosal Injection of Plasma-Rich Platelets on Blood Inflammatory Markers for Patients with Bimaxillary Protrusion Undergoing Orthodontic Treatment. Int J Inflam. 2019 Oct 1;2019:6715871. doi: 10.1155/2019/6715871. eCollection 2019.
PubMed 31662844Dixon V, Read MJ, O'Brien KD, Worthington HV, Mandall NA. A randomized clinical trial to compare three methods of orthodontic space closure. J Orthod. 2002 Mar;29(1):31-6. doi: 10.1093/ortho/29.1.31.
PubMed 11907307Ammar AM, Al-Sabbagh R, Hajeer MY. Evaluation of the effectiveness of the platelet-rich plasma compared to the injectable platelet-rich fibrin on the rate of maxillary canine retraction: a three-arm randomized controlled trial. Eur J Orthod. 2024 Jan 1;46(1):cjad056. doi: 10.1093/ejo/cjad056.
PubMed 37796117
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between The Effect of Platelet Rich Plasma (PRP) and Injectable Platelet Rich Fibrin (I-PRF) on Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT05335824
- Acronym / sponsor ID
- UHDS-Ortho-07-2022
- Conditions
- Class II Division 1 Malocclusion
- Keywords
- Platelet-rich plasma, Platelet-rich fibrin, Acceleration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Collaborators
- Hama University
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 19 Apr 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.
60 patients needed therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines were divided to randomly three groups:
(1) PRP group: Received PRP injections, (2) I-PRF group: Received I-PRF injections, (3) Control group: conventional treatment with no injections. TPAs were used as an anchor unit. Coil springs were used to distalize the upper canines on 0.019 x 0.025-inch stainless archwires. Alginate impressions and dental casts of the maxillary arch were done at five-time points over a 4-month follow-up period. The amount of canine movement, canine rotation, and anchorage loss were measured on three-dimensional digital models superimposed on the rugae area.
Detailed description
One of the most important goals of orthodontic treatment is to decrease the treatment time via achieving faster tooth movement chiefly in adults. Adults have more bone density and less bone turnover than adolescence, which may be linked to potential root resorption, periodontal problems, and white spot lesions.
Approaches to reduce orthodontic treatment time included surgical and non-surgical techniques. Non-surgical approaches such as systemic and local administration of chemical substances, low-level laser therapy, vibrations, and pulsed electrical stimulation therapy still need more studies to determine their safety and effectiveness.
Surgical procedures such as corticotomy, corticision, and micro-osteoperforations have
, in general high success rates, but they rely on incurring an injury to bone tissues. The latter has been linked to the regional acceleratory phenomenon (RAP). But the invasive nature of these procedures, associated risks of loss of alveolar bone and gingival recession, and the help needed from another specialist limit its routine application. Recently, the possibility of using platelet-based preparations from the patient's blood to accelerate orthodontic tooth movement like platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) has grown. PRF represents the second generation of biological materials derived from blood. It is obtained through a centrifuge of the patient's blood without adding any additives to the tube. The variety of growth factors in PRP and PRF may have the ability to stimulate the activation of osteoblasts and osteoclasts together, which supports the idea that PRP could affect orthodontic tooth movement The study sample consisted of 60 patients and was calculated using (G-power sample size calculator), depending on the rate of canine retraction with a study power of 90%.
After ensuring the patient's compliance with the terms and conditions of this study, the purpose and methods of the study were explained to the patients using Information Sheet. In case of approval to participate, the patients were asked to sign the informed consent. Extra \& Intra-oral photographs, impressions and clinical examinations were made.
Canine retraction was initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The platelet-rich plasma (PRP) group: | Experimental | Other: The platelet-rich plasma (PRP)The patients in this group received PRP injections immediately before the canine retraction, and after 8 weeks of the onset of retraction |
| The injectable platelet-rich fibrin (I-PRF) group | Experimental | Other: The injectable platelet-rich fibrin (I-PRF) groupThe patients in this group received I-PRF injections immediately before the canine retraction, and after 8 weeks of the onset of retraction |
| The control group | Active comparator | Device: The control groupThe patients in this group did not receive any injections |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- both male and female subjects
- 18-25 years old
- Class II Division 1 malocclusion, treated with extraction of the maxillary first premolars
- Full permanent dentition
- Good general and oral health
Key exclusion criteria (6 listed)
- extreme skeletal class II malocclusion, overjet > 10 mm ANB>7◦
- diseases and medications that were likely to affect bone biology
- poor oral hygiene
- previous orthodontic treatment
- smoking
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 |
|---|---|---|
| The platelet-rich plasma (PRP)Twenty ml of venous blood was drawn from each patient with the use of PRP tubes that contain anticoagulant citrate dextrose. The double-spin technique was used to prepare the PRP. The injection areas were anesthetized with lidocaine 2% with epinephrine 1/80000 and left for 10 minutes. 15 units (0. 15 mL) of PRP were injected interaligamentlly in the middle, distobuccal, and distopalatal areas of the distal surface of the upper canines (5 units in each area) together with submucosal injections buccally and palatally (100 units and 50 units , respectively). | Other | The platelet-rich plasma (PRP) group: |
| The injectable platelet-rich fibrin (I-PRF) groupTwenty ml of venous blood was drawn from each patient in this experimental group. I-PRF was prepared with the use of 20 ml of blood drawn from the patient in dry sterile tubes without anticoagulant (quickly before coagulation starts) by following the centrifugation protocol requires one cycle only (700 RPM for 3 minutes) Injection procedures, sites, and time were similar to the PRP group. | Other | The injectable platelet-rich fibrin (I-PRF) group |
| The control groupNiTi closed-coil springs (American Orthodontics, Sheboygan, WI) were used to impose 150 g force from the first molar band hook to the bracket of canine on each side on 0.019*0.025-in SS archwire Patients' follow-up appointments were two weeks intervals; at each visit, the force produced by the coil was checked and readjusted when needed in order to keep it at 150-g level and the appliances were examined for any deformation or change in the position because of chewing. Canine retraction continued until achieving Class I canine relationship. | Device | The control group |
Primary outcome
Change in canine retraction rate
Time frame: The estimation took place at five time points: the beginning of tooth movement (T0) and at 4, 8, 12, and 16 weeks following T0
The amount of canine retraction per month was calculated by measuring the distance from the canine cusp tip in the baseline model to the canine cusp tip in the next superimposed model. The amount of distance being retracted in millimeters was divided to the duration of retraction in months to give an estimation of the retraction rate.
2 secondary outcomes
Change in the maxillary first molar position (anchorage loss)
Time frame: T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction
Change in canine rotation
Time frame: T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction
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 19 Apr 2022.
- Background: PubMed 28414871Rashid A, ElSharaby FA, Nassef EM, Mehanni S, Mostafa YA. Effect of platelet-rich plasma on orthodontic tooth movement in dogs. Orthod Craniofac Res. 2017 May;20(2):102-110. doi: 10.1111/ocr.12146.
- Background: PubMed 30147398Tehranchi A, Behnia H, Pourdanesh F, Behnia P, Pinto N, Younessian F. The effect of autologous leukocyte platelet rich fibrin on the rate of orthodontic tooth movement: A prospective randomized clinical trial. Eur J Dent. 2018 Jul-Sep;12(3):350-357. doi: 10.4103/ejd.ejd_424_17.
- Background: PubMed 32591274Reyes Pacheco AA, Collins JR, Contreras N, Lantigua A, Pithon MM, Tanaka OM. Distalization rate of maxillary canines in an alveolus filled with leukocyte-platelet-rich fibrin in adults: A randomized controlled clinical split-mouth trial. Am J Orthod Dentofacial Orthop. 2020 Aug;158(2):182-191. doi: 10.1016/j.ajodo.2020.03.020. Epub 2020 Jun 24.
- Background: PubMed 33481053Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
- Background: PubMed 31662844Ali Mahmood TM, Chawshli OF. The Effect of Submucosal Injection of Plasma-Rich Platelets on Blood Inflammatory Markers for Patients with Bimaxillary Protrusion Undergoing Orthodontic Treatment. Int J Inflam. 2019 Oct 1;2019:6715871. doi: 10.1155/2019/6715871. eCollection 2019.
- Background: PubMed 11907307Dixon V, Read MJ, O'Brien KD, Worthington HV, Mandall NA. A randomized clinical trial to compare three methods of orthodontic space closure. J Orthod. 2002 Mar;29(1):31-6. doi: 10.1093/ortho/29.1.31.
- Derived from this study: PubMed 37796117Ammar AM, Al-Sabbagh R, Hajeer MY. Evaluation of the effectiveness of the platelet-rich plasma compared to the injectable platelet-rich fibrin on the rate of maxillary canine retraction: a three-arm randomized controlled trial. Eur J Orthod. 2024 Jan 1;46(1):cjad056. doi: 10.1093/ejo/cjad056.
- 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.
Ali Ammar, DDS, MSc principal investigator
Department of orthodontics, Hama University, Syria
Rabab al-Sabbagh, DDS,MSc,PhD study director
Department of orthodontics, Hama 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 The platelet-rich plasma (PRP) and The injectable platelet-rich fibrin (I-PRF) group in people with Class II Division 1 Malocclusion, 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 5 inclusion and 6 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 19 Apr 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 canine retraction rate (time frame: The estimation took place at five time points: the beginning of tooth movement (T0) and at 4, 8, 12, and 16 weeks following T0). 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 NCT05335824, which also lists 7 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 19 Apr 2022.