None listed
Conditions
Interventions
Procedure/Surgery : The order of allocation of medical devices according to the test subject registration number is programmed using SAS by the statistician Block Randomization method of this study.
A
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) aged at least 20 years, (2) having an edentulous area and requiring implantation (3) smoking fewer than 10 cigarettes daily 4) Those who can understand and follow the instructions and participate in the entire period of the clinical trial 5) Those who have decided to voluntarily participate in this clinical study and have agreed in writing to the test subject consent form
Exclusion criteria
Exclusion criteria: (1) osteogenesis-related diseases or taking medications that affect bone formation, (2) taking oral or parenteral rheumatic drugs including immunosuppressants, (3) uncontrolled hypertension or diabetes mellitus, (4) hemorrhagic disease, (5)Patients with uncontrolled periodontal disease (6) oral mucosal disease or lesions, (7) history of oral maxillofacial radiation therapy, (8) Patients who have or have been prescribed osteoporosis treatment for oral or intravenous bisphosphonate treatment for more than 3 months in the past (However, patients who have discontinued medication for more than 3 months and have a CTx level of 0.150ng / ml or higher can participate in clinical studies) 9) Applicable to any of the following items on the test / control medical device application area i. Those who have had bone grafts or implants in the past ii. Those who have removed tumors in the past iii. A person with osteomyelitis iv. A person with vascular damage 10) Those who are alcoholic or have decreased immunity 11) Those with severe irritability or irritability 12) Those who lack oral hygiene management ability 13) Those who have severe clinical impairment in cardiovascular, digestive, respiratory, endocrine, and central nervous system or who have mental illness that has a significant effect on the clinical trial 14) Those who participated in other clinical trials within 30 days from the screening date 15) Pregnant or lactating women 16) Patients with hypersensitivity to implants 17) In addition to the above, persons with clinical findings who are judged medically by the investigator or person in charge and considered to be inappropriate for this test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| marginal bone loss arount implant | — |
Secondary
| Measure | Time frame |
|---|---|
| implant safety rate | — |
Countries
Korea, Republic of
Contacts
Public ContactLee Seok
Yonsei University
Outcome results
None listed