Feasibility and Performance Evaluation of a New Implant System in Patients Receiving Antiresorptive or Antiangiogenic Therapy: A Single-Arm Prospective Clinical Trial with 30 Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010942

Enrollment

Registered

2025-08-26

Start date

2025-08-29

Completion date

Unknown

Last updated

2025-09-22

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

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : The intervention consists of dental implant placement using the Bright implant system fixture. Eligible patients undergo tooth extraction, followed by implant place

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: This study employs a non-probability sampling method. Participants will be consecutively recruited from outpatients of the Department of Oral and Maxillofacial Surgery at Ewha Womans University Seoul Hospital, who meet the inclusion criteria and do not fall under the exclusion criteria. Only those who voluntarily provide informed consent will be enrolled. Adults aged 19 years or older Patients with a history of, or currently receiving, long-term antiresorptive therapy (IV bisphosphonates, denosumab, angiogenesis inhibitors, or oral agents for =2 years) No diagnosis of medication-related osteonecrosis of the jaw (MRONJ) Patients requiring tooth extraction and dental implant placement due to periodontitis, dental caries, or tooth fracture Individuals who have been fully informed of the study purpose and procedures and voluntarily provide written informed consent

Exclusion criteria

Exclusion criteria: History of radiotherapy involving the jaws or head and neck region Diagnosis of malignant tumors in the jaw region or multiple myeloma Patients treated for MRONJ within the past 1 year Known hypersensitivity to dental implant materials Patients with severe oral parafunctional habits (e.g., bruxism, clenching) Smokers Patients deemed inappropriate for participation by the investigator due to ethical or clinical concerns Patients unable to understand the study purpose or unwilling to provide informed consent

Design outcomes

Primary

Measure	Time frame
Implant survival rate (assessed by implant removal status after prosthesis placement)	—

Secondary

Measure	Time frame
Implant success rate (evaluated by presence of mobility, infection, peri-implantitis, prosthetic or biological complications);Implant stability (measured by implant mobility test)	—

Countries

Korea, Republic of

Contacts

Public ContactHeonYoung Kim

Ewha Womans University Seoul Hospital

eumc01055@ewha.ac.kr+82-2-6986-3405

Outcome results