Biting ForcesPhase 2NCT07007572
Evaluation Of Marginal Bone Height Changes And Biting Force In Screw Retained Implant Prostheses Using Reinforced Resin Vs Monolithic Zirconium
A Phase 2 study testing Digitally-fabricated implant supported supra-structure fabricated from reinforced resin and Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia in people with Biting Forces and Bone; Change, Diabetic (Manifestation), run by Cairo University at 2 sites in Egypt.
Trial summary
This studies aims to compare the behavior of recently introduced resin reinforces compared to monolithic zirconia Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Biting Forces, Bone; Change, Diabetic (Manifestation), Color Stability
- What is being tested?
- Digitally-fabricated implant supported supra-structure fabricated from reinforced resin and Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesEgypt
- Study dates
- 31 Dec 2024to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mandibular Class II, partially edentulous patients that enables measuring the marginal bone height changes and values of biting forces intra-orally.
- Fully dentulous edentulous opposing Maxillary arch.
- Patients with normal class I jaw relationship.
- Patients that require fixed restorations for functional and esthetic reasons
- Age range (30-60 years).
- Cooperative patients those are willing to attend all follow-up periods.
Show all 9Show fewer
- Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
- Patients with healthy bone of appropriate thickness, width and height free from any inflammation.
- Patients without any medical conditions that contraindicates implant placement.
Who cannot join
- Patients with Parkinson's disease
- Patients with xerostomia.
- Patients with a history of allergy to resins and/ or zirconia.
- Patients with a medical systematic condition that contraindicate implant placement.
- Patients smoking more than 10 cigarettes per day.
- Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
- Patients with large irregular bony exostosis.
- Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reham Osman, Professor contact
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, 12613
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, 12613
Faculty of Dentistry Cairo university, 002010 02159535, adj@dentistry.cu.edu.eg
mahmoud Saleh Fayed, Assistant lecturer
About this study
Official title: Evaluation Of Marginal Bone Height Changes And Biting Force In Screw Retained Implant Prostheses Using Reinforced Resin Vs Monolithic Zirconium Used In Unilateral Distal Extension Cases
This studies aims to compare the behavior of recently introduced resin reinforces compared to monolithic zirconia
Read the detailed description
The clinical success of implant-supported prostheses is significantly influenced by the material used, as it directly affects both prosthetic longevity and patient satisfaction. Monolithic zirconia, despite its widespread popularity, presents notable clinical challenges. Its excessive rigidity often leads to mechanical failures such as chipping, fractures, and increased wear of the opposing dentition. Moreover, zirconia's limited ability to absorb and dissipate occlusal forces can result in elevated stresses on implant components, contributing to screw loosening or fractures and necessitating frequent maintenance interventions. These complications not only escalate the overall cost of care but also negatively impact patient outcomes, leading to discomfort, inconvenience, and dissatisfaction. Consequently, there is a pressing need to explore alternative restorative materials that maintain strength and esthetic appeal while mitigating these clinical issues. Biomimetic reinforced resin composites, engineered to emulate the mechanical behavior of natural tooth structures, offer a promising solution. By more effectively absorbing and distributing occlusal forces, these materials may reduce stress on both prostheses and surrounding tissues. If clinically validated, biomimetic resins could lead to fewer mechanical complications, improved bone preservation, and enhanced overall durability of implant-supported prostheses. The clinical implications of adopting biomimetic reinforced resin are substantial; a material that reduces the frequency of repairs and replacements compared to monolithic zirconia would mark a significant advancement in prosthetic dentistry, offering clinicians a superior restorative option and improving patient satisfaction through more stable, long-term outcomes.
To investigate this, mandibular Class II partially edentulous patients will be recruited from the outpatient clinic at the Department of Prosthodontics, Cairo University, based on specific inclusion criteria. After obtaining informed consent and conducting a comprehensive clinical examination, each patient will receive two implants in the edentulous area, restored initially with a screw-retained bridge made of milled monolithic zirconia. After six months, the zirconia bridge will be replaced with a milled resin-reinforced composite bridge. The sequence of material placement will be randomized for each participant, ensuring that each patient uses both materials sequentially without a washout period.
Intraoral scans and digital bite registrations will be performed, and prostheses will be designed using CAD software. Fabrication will follow standardized milling techniques for both zirconia and resin-reinforced composite materials. Bone levels around the implants will be evaluated using long cone parallel periapical radiographs, with measurements recorded at 0 and 6 months during each material phase. This approach allows for direct comparison of the two materials' effects on peri-implant bone health.
Biting forces will also be assessed using an occlusal force meter. A reference bite force will be measured on the intact side, followed by measurements on the intervention side after the placement of each restorative material. Each measurement will be repeated five times and averaged to ensure accuracy. All data regarding bone levels and biting forces will be recorded, tabulated, and statistically analyzed in the presence of an outcome assessor during clinical visits. Through this study design, it will be possible to evaluate the mechanical and biological performance of monolithic zirconia versus biomimetic reinforced resin composites in implant-supported prostheses.
- Conditions
- Biting Forces, Bone; Change, Diabetic (Manifestation), Color Stability, Disorder of Soft Tissue, Prosthetic Complications, Bacterial Overgrowth
- Being tested
- Digitally-fabricated implant supported supra-structure fabricated from reinforced resin, Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia
- Keywords
- biting forces, Bacterial Adhesion, color stability, soft tissue response, prosthetic complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally-fabricated implant supported supra-structure fabricated from reinforced resinCombination product
A comprehensive clinical examination with an understanding of patients' chief complaints and needs will be carried out. For each patient, two implants will be placed in the edentulous area, and the patient will receive a screw-retained bridge supported by both implants made of milled monolithic zirconia (Dental Direkt Zirconia, Germany). After 6 months, the zirconia restoration will be replaced with a milled resin-reinforced composite (Nanoska G Plus, USA), allowing the same patient to use the new restoration for another 6 months. Randomization will be performed to determine the sequence of bridge material for each participant. Accordingly, the two restorations will be sequentially delivered to each participant with no gap (wash-up period) between them. Consent will be signed by the selected participants after explaining the detailed information of the trial.
Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconiaCombination product
Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia
| Study group | Role | What they receive |
|---|---|---|
| patients who receives a screw retained monolithic zirconia bridge | Active comparator | Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia Receives: Combination Product: Digitally-fabricated implant supported supra-structure fabricated from reinforced resin |
| patients who receives a screw retained resin reinforced bridge | Experimental | Digitally-fabricated implant supported supra-structure fabricated from reinforced resin Receives: Combination Product: Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the Bone height changes (bone level)
Change in marginal bone height (in millimeters) measured using long cone parallel peri-apical radiographs at baseline and 6 months for each prosthetic material phase (monolithic zirconia and resin-reinforced). Radiographs will be taken at four time points:
Start of phase 1 (zirconia, baseline)
End of phase 1 (zirconia, 6 months)
Start of phase 2 (resin-reinforced, baseline)
End of phase 2 (resin-reinforced, 6 months)
Bone level will be assessed on the mesial and distal surfaces of each implant using a standardized radiographic protocol.
Measured: 6 months for each arm
Secondary outcomes (1)
Average Maximum Biting Force
Average maximum static biting force (in Newtons) recorded using an occlusal force meter. For each prosthetic material phase (monolithic zirconia and resin-reinforced), patients will bite on the sensor five times per side. The average value from the intervention side (restored side) will be compared with that of the intact side. Measurements will be taken after prosthetic delivery for both phases and compared using statistical analysis to assess relative performance.
Time Points:
After placement of zirconia prosthesis
After placement of resin-reinforced prosthesis
Tool Used:
Occlusal force meter with digital sensor, positioned on molars of both the intact and intervention sides.
Measured: 6 months for each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start31 Dec 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Biting ForcesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Saleh Fayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007572
- Sponsor's protocol ID
- 31-12-24
- Status last verified
- Jun 2025
- First submitted
- 18 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, no final decision has been made regarding the sharing of individual participant data (IPD). The decision will depend on factors such as participant consent, institutional policies, data privacy considerations, and the potential for future collaborative research. If data sharing is approved, it will comply with all applicable ethical and legal standards.
Publications
Roh, K.-W. et al. (2019) 'A prospective clinical of lithium disilicate pressed zirconia and monolithic zirconia in posterior implant-supported prostheses: A 24-month follow-up', The Journal of Korean Academy of Prosthodontics, 57(2), p. 134. doi: 10.4047/jkap.2019.57.2.134.
Nitschke I, Moede C, Hopfenmuller W, Sobotta BAJ, Koenig A, Jockusch J. Validation of a New Measuring Instrument for the Assessment of Bite Force. Diagnostics (Basel). 2023 Nov 21;13(23):3498. doi: 10.3390/diagnostics13233498.
PubMed 38066739Liu, Y., Wang, S. and Chen, J. (2023) 'Challenges of monolithic zirconia in implant prosthodontics: Biting forces and maintenance considerations', Journal of Prosthetic Dentistry, 132(1), pp. 75-82. Available at: https://www.journals.elsevier.com/the-journal- of-prosthetic-dentistry.
Lee, K. H., Patel, M. A. and Smith, A. D. (2023) 'Enhancing function and esthetics in partial edentulism: The role of biomimetic materials', Journal of Prosthetic Dentistry, 130(2), pp. 150-158. Available at: https://www.journals.elsevier.com/the-journal-of-prosthetic- dentistry.
Gomez, P. H. et al. (2023) 'Advances in resin composites: A review of biomimetic approaches in prosthetic dentistry', Journal of Prosthetic Dentistry. Available at: https://www.journals.elsevier.com/the-journal-of-prosthetic-dentistry.
Ahmed, N., Patel, A. and Zhang, X. (2024) 'Prosthetic Rehabilitation of Edentulous Patients: A Systematic Review of Complications and Management', International Journal of Prosthodontics, 37(2), pp. 214-223. doi: 10.11607/ijp.7698.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Marginal Bone Height Changes And Biting Force In Screw Retained Implant Prostheses Using Reinforced Resin Vs Monolithic Zirconium Used In Unilateral Distal Extension Cases
- ClinicalTrials.gov ID
- NCT07007572
- Acronym / sponsor ID
- 31-12-24
- Conditions
- Biting Forces, Bone; Change, Diabetic (Manifestation), Color Stability, Disorder of Soft Tissue, Prosthetic Complications, Bacterial Overgrowth
- Keywords
- biting forces, Bacterial Adhesion, color stability, soft tissue response, prosthetic complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 6 Jun 2025 (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.
This studies aims to compare the behavior of recently introduced resin reinforces compared to monolithic zirconia
Detailed description
The clinical success of implant-supported prostheses is significantly influenced by the material used, as it directly affects both prosthetic longevity and patient satisfaction. Monolithic zirconia, despite its widespread popularity, presents notable clinical challenges. Its excessive rigidity often leads to mechanical failures such as chipping, fractures, and increased wear of the opposing dentition. Moreover, zirconia's limited ability to absorb and dissipate occlusal forces can result in elevated stresses on implant components, contributing to screw loosening or fractures and necessitating frequent maintenance interventions. These complications not only escalate the overall cost of care but also negatively impact patient outcomes, leading to discomfort, inconvenience, and dissatisfaction. Consequently, there is a pressing need to explore alternative restorative materials that maintain strength and esthetic appeal while mitigating these clinical issues. Biomimetic reinforced resin composites, engineered to emulate the mechanical behavior of natural tooth structures, offer a promising solution. By more effectively absorbing and distributing occlusal forces, these materials may reduce stress on both prostheses and surrounding tissues. If clinically validated, biomimetic resins could lead to fewer mechanical complications, improved bone preservation, and enhanced overall durability of implant-supported prostheses. The clinical implications of adopting biomimetic reinforced resin are substantial; a material that reduces the frequency of repairs and replacements compared to monolithic zirconia would mark a significant advancement in prosthetic dentistry, offering clinicians a superior restorative option and improving patient satisfaction through more stable, long-term outcomes.
To investigate this, mandibular Class II partially edentulous patients will be recruited from the outpatient clinic at the Department of Prosthodontics, Cairo University, based on specific inclusion criteria. After obtaining informed consent and conducting a comprehensive clinical examination, each patient will receive two implants in the edentulous area, restored initially with a screw-retained bridge made of milled monolithic zirconia. After six months, the zirconia bridge will be replaced with a milled resin-reinforced composite bridge. The sequence of material placement will be randomized for each participant, ensuring that each patient uses both materials sequentially without a washout period.
Intraoral scans and digital bite registrations will be performed, and prostheses will be designed using CAD software. Fabrication will follow standardized milling techniques for both zirconia and resin-reinforced composite materials. Bone levels around the implants will be evaluated using long cone parallel periapical radiographs, with measurements recorded at 0 and 6 months during each material phase. This approach allows for direct comparison of the two materials' effects on peri-implant bone health.
Biting forces will also be assessed using an occlusal force meter. A reference bite force will be measured on the intact side, followed by measurements on the intervention side after the placement of each restorative material. Each measurement will be repeated five times and averaged to ensure accuracy. All data regarding bone levels and biting forces will be recorded, tabulated, and statistically analyzed in the presence of an outcome assessor during clinical visits. Through this study design, it will be possible to evaluate the mechanical and biological performance of monolithic zirconia versus biomimetic reinforced resin composites in implant-supported prostheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who receives a screw retained monolithic zirconia bridge | Active comparator | Combination Product: Digitally-fabricated implant supported supra-structure fabricated from reinforced resinDigitally-fabricated implant supported supra-structure fabricated from monolithic zirconia |
| patients who receives a screw retained resin reinforced bridge | Experimental | Combination Product: Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconiaDigitally-fabricated implant supported supra-structure fabricated from reinforced resin |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Mandibular Class II, partially edentulous patients that enables measuring the marginal bone height changes and values of biting forces intra-orally.
- Fully dentulous edentulous opposing Maxillary arch.
- Patients with normal class I jaw relationship.
- Patients that require fixed restorations for functional and esthetic reasons
- Age range (30-60 years).
Key exclusion criteria (8 listed)
- Patients with Parkinson's disease
- Patients with xerostomia.
- Patients with a history of allergy to resins and/ or zirconia.
- Patients with a medical systematic condition that contraindicate implant placement.
- Patients smoking more than 10 cigarettes per day.
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 |
|---|---|---|
| Digitally-fabricated implant supported supra-structure fabricated from reinforced resinA comprehensive clinical examination with an understanding of patients' chief complaints and needs will be carried out. For each patient, two implants will be placed in the edentulous area, and the patient will receive a screw-retained bridge supported by both implants made of milled monolithic zirconia (Dental Direkt Zirconia, Germany). After 6 months, the zirconia restoration will be replaced with a milled resin-reinforced composite (Nanoska G Plus, USA), allowing the same patient to use the new restoration for another 6 months. Randomization will be performed to determine the sequence of bridge material for each participant. Accordingly, the two restorations will be sequentially delivered to each participant with no gap (wash-up period) between them. Consent will be signed by the selected participants after explaining the detailed information of the trial. | Combination product | patients who receives a screw retained monolithic zirconia bridge |
| Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconiaDigitally-fabricated implant supported supra-structure fabricated from monolithic zirconia | Combination product | patients who receives a screw retained resin reinforced bridge |
Primary outcome
Measurement of the Bone height changes (bone level)
Time frame: 6 months for each arm
Change in marginal bone height (in millimeters) measured using long cone parallel peri-apical radiographs at baseline and 6 months for each prosthetic material phase (monolithic zirconia and resin-reinforced). Radiographs will be taken at four time points: Start of phase 1 (zirconia, baseline) End of phase 1 (zirconia, 6 months) Start of phase 2 (resin-reinforced, baseline) End of phase 2 (resin-reinforced, 6 months) Bone level will be assessed on the mesial and distal surfaces of each implant using a standardized radiographic protocol.
1 secondary outcome
Average Maximum Biting Force
Time frame: 6 months for each arm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Results publicationRoh, K.-W. et al. (2019) 'A prospective clinical of lithium disilicate pressed zirconia and monolithic zirconia in posterior implant-supported prostheses: A 24-month follow-up', The Journal of Korean Academy of Prosthodontics, 57(2), p. 134. doi: 10.4047/jkap.2019.57.2.134.
- Results publication: PubMed 38066739Nitschke I, Moede C, Hopfenmuller W, Sobotta BAJ, Koenig A, Jockusch J. Validation of a New Measuring Instrument for the Assessment of Bite Force. Diagnostics (Basel). 2023 Nov 21;13(23):3498. doi: 10.3390/diagnostics13233498.
- Results publicationLiu, Y., Wang, S. and Chen, J. (2023) 'Challenges of monolithic zirconia in implant prosthodontics: Biting forces and maintenance considerations', Journal of Prosthetic Dentistry, 132(1), pp. 75-82. Available at: https://www.journals.elsevier.com/the-journal- of-prosthetic-dentistry.
- Results publicationLee, K. H., Patel, M. A. and Smith, A. D. (2023) 'Enhancing function and esthetics in partial edentulism: The role of biomimetic materials', Journal of Prosthetic Dentistry, 130(2), pp. 150-158. Available at: https://www.journals.elsevier.com/the-journal-of-prosthetic- dentistry.
- Results publicationGomez, P. H. et al. (2023) 'Advances in resin composites: A review of biomimetic approaches in prosthetic dentistry', Journal of Prosthetic Dentistry. Available at: https://www.journals.elsevier.com/the-journal-of-prosthetic-dentistry.
- Results publicationAhmed, N., Patel, A. and Zhang, X. (2024) 'Prosthetic Rehabilitation of Edentulous Patients: A Systematic Review of Complications and Management', International Journal of Prosthodontics, 37(2), pp. 214-223. doi: 10.11607/ijp.7698.
- Individual participant dataSharing planned: Undecided. At this time, no final decision has been made regarding the sharing of individual participant data (IPD). The decision will depend on factors such as participant consent, institutional policies, data privacy considerations, and the potential for future collaborative research. If data sharing is approved, it will comply with all applicable ethical and legal standards.
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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.
Reham Osman, Professor contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Digitally-fabricated implant supported supra-structure fabricated from reinforced resin and Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia in people with Biting Forces and Bone; Change, Diabetic (Manifestation), run by Cairo University at 2 sites 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Saleh Fayed, Assistant lecturer (00201141565676, mahmoud.fayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the Bone height changes (bone level) (time frame: 6 months for each arm). 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 NCT07007572, which also lists 6 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 Jun 2025.