Comparison of Prognosis between Bone Level Implant and Tissue Level Implant: A Prospective Randomized Controlled Clinical Study
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0009334
- Lead Sponsor
- Yonsei University Health System, Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 58
? Adults over 19 years of age and under 65 years of age (patients over 65 years of age are excluded due to risk of osteoporosis and decreased bone density)
? Patients who require implant placement after tooth extraction for reasons such as periodontal disease, tooth fracture, or dental caries in one of the lower molar teeth (limited to exclude cofactors depending on the implant placement site)
? Patients whose alveolar bone shape and bone quality at the implantation site are suitable and who can obtain insertion torque of 20N
* Implant placement accompanied by bone grafting is also possible, in which case Bio-oss must be used within 0.5g and only Bio-Gide must be used.
? Patients scheduled to have a single implant installed (only one implant can be implanted per branch, so one study subject can participate in up to two implants)
? Patients with no possibility of becoming pregnant
? Patients with uncontrolled metabolic systemic diseases (e.g. diabetes)
? Patients with a history of radiation treatment and chemotherapy to the head and neck area
? Patients with a history of taking drugs that inhibit bone metabolism (Bisphosphonate or Denosumab) within the past 4 months
? Patients suffering from systemic or oral diseases that are contraindications to implant surgery
? Patients with insertion torque of less than 20N during implant surgery
? Patients with severe bruxism with clear clinical signs and symptoms
? Smokers who smoke more than one pack a day
? Persons lacking medical ability (including the disabled)
? Pregnant women, lactating women and minors
? If the test subject withdraws consent
? Other patients deemed inappropriate by clinicians
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method bone level (radiological evaluation)
- Secondary Outcome Measures
Name Time Method Implant Stability Test (IST);Periotest value (PTV)