None listed
Conditions
Interventions
None listed
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Over 20 years old 2) Implant placement does not have any contraindicated systemic/localized disease or condition 3) In the maxilla or mandible, a deterioration defect of 3 mm or more in apex-crown width should be expected to occur around at least one implant. 4) The initial stability of the implant is secured 5) Implant placement should be done at least 2 months after extraction 6) No soft tissue transplantation required after implant placement 7) Implant placement should be done at least 2 months after soft tissue transplantation. 8) Non-smokers, smokers who smoke less than 10 cigarettes a day 9) Those with no possibility of pregnancy
Exclusion criteria
Exclusion criteria: 1) Those who have taken medicines that interfere with bone formation within 2 weeks from the time of screening (e.g., adrenal corticosteroids) or are likely to take them during the clinical trial period 2) Those who administered oral or injectable rheumatism treatment including immunosuppressants within 2 weeks from the time of screening 3) Patients with uncontrolled diabetes or high blood pressure 4) Those with oral skin diseases or lesions (eg, erosive lichen planus, erosive lichen planus, stomatitis, ulcers, malignant tumors) 5) Those suffering from osteomyelitis 6) In the past, oral or injectable bisphosphonate drugs to treat osteoporosis for more than 3 months Those who have been or are receiving the administration (However, according to the AAOMS standard, discontinuation of the administration for more than 3 months, those with a CTx level of 0.150ng/ml or more may participate in the clinical study) 7) A person who meets any of the following items in the area where the test/control medical device is applied i. Those with past bone graft or implant experience ii. Those who have had a tumor removed in the past 8) Those who lack oral hygiene management skills 9) Those with mental disorders that have a significant impact on this clinical trial 10) Pregnant or lactating women 11) In addition to the above, a person who has clinically significant findings deemed inappropriate for this test as a result of medical judgment by the person in charge or in charge of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hard tissue: The amount of change in alveolar bone width and height at the end point | — |
Secondary
| Measure | Time frame |
|---|---|
| Soft tissue: The amount of change in the volume of buccal soft tissue at the end point | — |
Countries
Korea, Republic of
Contacts
Public ContactJong Kim
Yonsei University Health System, Dental Hospital
Outcome results
None listed