None listed
Conditions
Interventions
Medical Device : 1) Tissue Level vs Bone Level Implant
1-1) Test Device: Dentium Bright Implant (Tissue Level)
1-2) Control Device: Dentium SuperLine Implant (Bone Level)
2) Guided Implant Surgery So
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Individuals aged 20 years or older • Patients requiring implant treatment due to tooth loss • Non-smokers or smokers who smoke 10 cigarettes or fewer per day • Individuals who can understand and follow the instructions and participate throughout the entire clinical trial period • Individuals who voluntarily choose to participate in this clinical study and have provided written consent through the subject consent form
Exclusion criteria
Exclusion criteria: Individuals who have taken medications that interfere with bone formation (e.g., corticosteroids) within 2 weeks prior to screening or are likely to take such medications during the clinical trial period (except for one-time emergency use during the trial period). • Individuals who have taken oral or injectable rheumatic treatments, including immunosuppressive agents, within 2 weeks prior to screening. • Patients with uncontrolled diabetes or hypertension. • Patients with bleeding disorders. • Patients with uncontrolled periodontal disease. • Individuals with oral skin diseases or lesions (e.g., erosive lichen planus, ulcerative lichen planus, stomatitis, ulcers, malignant tumors). • Individuals who have previously received radiation therapy in the oral cavity. • Individuals who have taken oral or injectable Bisphosphonates or denosumab for osteoporosis treatment for more than 3 years, or are currently taking them (however, based on AAOMS criteria, those who have discontinued medication for more than 3 months and have a CTx level of 0.150ng/ml or higher are eligible for participation). • Individuals with any of the following at the site of the test/control medical device application: • Individuals with prior bone grafting or implant experience. • Individuals who have previously had a tumor removed (patients who have received cancer treatment and are in remission with regular check-ups are eligible for participation). • Individuals with osteomyelitis. • Individuals with vascular damage. • Individuals with alcohol addiction or compromised immunity. • Individuals with severe bruxism or teeth grinding habits. • Individuals with insufficient oral hygiene management skills. • Individuals showing clinically significant disabilities in the cardiovascular, digestive, respiratory, endocrine, or central nervous systems, or those with psychiatric disorders that may significantly affect the clinical trial. • Individuals who have participated in another clinical trial within 30 days prior to screening. • Pregnant or breastfeeding women. • Patients with hypersensitivity to implants. • Any other individuals deemed clinically inappropriate for the study by the investigator or study staff based on medical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| marginal bone resorption | — |
Secondary
| Measure | Time frame |
|---|---|
| RMS value | — |
Countries
Korea, Republic of
Contacts
Public ContactJin-Sil HONG
Seoul National University Bundang Hospital
Outcome results
None listed