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Clinical outcomes of SOI implants in postmenopausal woman

Comparative study of clinical outcomes of SOI implants (SLA surface coated with a pH-buffering agent after vacuum UV treatment) in healthy patients with osteoporosis/osteopenia: an open-label prospective case-control study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007100
Enrollment
40
Registered
2022-03-18
Start date
2022-03-21
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Marginal bone level measurement: apical photo and CT data (1st surgery, 2nd surgery, follow-up period after prosthetic function)

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactJun-Young Kim

Yonsei University

jyomfs@yuhs.ac+82-2-2228-3130

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026