Clinical outcomes of SOI implants in postmenopausal woma
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007100
- Lead Sponsor
- Yonsei University Health System, Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 40
Among the patients who visited Yonsei University College of Dentistry Hospital, among postmenopausal women aged 55 years or older, according to the T-Score, osteoporosis/osteopenia patients group (-3-1) were classified. It is aimed at patients who have missing teeth and need dental implants. (However, at least 3 months have passed since tooth extraction in the edentulous area)
1. Patients who have previously received head and neck radiation therapy or who have received anti-absorbent drugs (bisphosphonate and denosumab) within the past 1 year for the treatment of osteoporosis
2. Patients with other metabolic bone diseases (Paget's disease, hyperparathyroidism, fibrotic dysplasia, etc.)
3. If a bone graft has been previously performed or extensive bone grafting is required
4. A person who falls under any of the following in the medical device application area
? Those who have had tumors removed in the past
? those with osteomyelitis
? those with blood vessel damage
5. People with uncontrolled diabetes or high blood pressure
6. Heavy smokers (more than 20 cigarettes/day) and alcoholics
7. Patients with severe periodontal disease and tooth decay that may affect implant placement
8. A person who is considered by the research director to have other diseases that may affect bone regeneration and research other than the above
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Marginal bone level measurement: apical photo and CT data (1st surgery, 2nd surgery, follow-up period after prosthetic function)
- Secondary Outcome Measures
Name Time Method Resonance frequency analysis :ISQ level ;Measurement of osteoporosis and osseointegration-related values in the surrounding marginal and jaw bones through fractal analysis;Implant survival rate, peri-implantitis evaluation;T-score test through DXA and blood test for bone turnover marker