KCT0005545
Recruiting
未知
Bone-guided regeneration of NR Line implant peripheral defects: a prospective randomized clinical study
Yonsei University Health System, Dental Hospital0 sites40 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Sponsor
- Yonsei University Health System, Dental Hospital
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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