Clinical comparison of marginal bone loss around the implant after implantation of two types of implants
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003791
- Lead Sponsor
- Yonsei University Health System, Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
(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
(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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method marginal bone loss arount implant
- Secondary Outcome Measures
Name Time Method implant safety rate