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feasibility of implant placement in patients with osteonecrosis of the jaw using a new surface-treated implant: a single-group prospective exploratory clinical trial

feasibility of implant placement in patients with osteonecrosis of the jaw using a new surface-treated implant: a single-group prospective exploratory clinical trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009654
Enrollment
20
Registered
2024-07-26
Start date
2022-04-12
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Ewha Womans University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Adult patients whose age is over 19 years of age and whose jaw growth has been completed ? If you have or have been given a medication that can cause jaw necrosis:IV Bisphosphonate, Denosumab, Angiogenesis inhibitor, etc.Oral use for more than 2 years have been diagnosed with osteonecrosis of the jaw amd have undergone bone resection surgery, then 6 months after complete recovery ? Patients who agreed to participate in the clinical trial and signed the patient consent form

Exclusion criteria

Exclusion criteria: ? If there is a history of radiation therapy in the head and neck, including jaw, or a malignant tumor of the jaw area ? Patients who unctrolled systemic disease, including hemorrhagic diseases ? Patients who have hypersensitivity to implant, metal plate materials, or implant materials ? Patients requiring extensive bone grafting ? Patients who have severe oral and jaw habits(bruxism, clenching) ? If the investigator determines that participation in the clinical trial is inappropriate because it may affect other ethical or clinical trial results. ? Patients who find implant placement surgery difficult (uncooperative patients, cases with very poor oral hygiene management, etc.) ? Patients who do not understand the purpose of the research and do not agree

Design outcomes

Primary

MeasureTime frame
Initial stability (measured by RFA levels);Long-term stability (marginal bone resorption)

Secondary

MeasureTime frame
Clinical characteristic / Demographic evaluation;Radiation examination

Countries

Korea, Republic of

Contacts

Public ContactJi-soo Song

Ewha Womens University

dhewjs22@gmail.com+82-2-6986-6309

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026