None listed
Conditions
Interventions
Medical Device : - Blinding: Single blind
- Control: Bio-Oss
- Randomization:
The order of allocation of medical devices according to the test subject registration number is to use block randomizati
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Persons 20 years of age or older 2) Patients requiring extraction and implant treatment due to periodontitis 3) Non-smokers or smokers less than 10 cigarettes a day 4) Those who can understand and follow the instructions and participate in the period before the clinical trial 5) Those who have decided to voluntarily participate in this clinical study and have agreed in writing with the consent form
Exclusion criteria
Exclusion criteria: 1) Those who have taken medicines (eg, corticosteroids) that interfere with bone formation within 2 weeks of screening, or who are likely to take them during the clinical trial 2) Those who received oral or parenteral rheumatic drugs containing immunosuppressive drugs within 2 weeks of screening 3) Patients with uncontrolled diabetes or hypertension 4) those with oral skin disease or lesions (eg, erosive lichen planus, erosive squamous cell carcinoma, oralitis, ulcer, malignant tumor) 5) Those with osteomyelitis 6) Patients who have been or have been administered bisphosphonate preparations for oral or intravenous use for more than 3 months in the past, for the treatment of osteoporosis (Clinical studies should be done according to the AAOMS criteria for patients who have discontinued for more than 3 months and have a CTx level of 0.150ng / ml or more) 7) Applicants who have at least one of the following items in the test / control medical device application area I. Those who have had bone grafts or implants in the past Ii. Anyone who has ever had tumor resection in the past 8) Persons lacking oral hygiene management ability 9) Those who have mental illness that has a significant effect on the clinical trial 10) Pregnant or lactating women 11) In addition to the above, those who have medical opinion and clinical findings that are deemed inappropriate for this test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the height of alveolar bone after 4 months compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the area of cross-sectional view of alveolar bone ridge;changes in the buccolingual width of alveolar bone rdige | — |
Countries
Korea, Republic of
Contacts
Public ContactChang-sung Kim
Yonsei University Health System, Dental Hospital
Outcome results
None listed