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Comparison of Prognosis between Bone Level Implant and Tissue Level Implant: A Prospective Randomized Controlled Clinical Study

Comparison of Prognosis between Bone Level Implant and Tissue Level Implant: A Prospective Randomized Controlled Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009334
Enrollment
58
Registered
2024-04-12
Start date
2024-04-15
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

None listed

Interventions

Medical Device : The difference between the implants used in the study, the Tissue Level (TL) implant and the Bone level (BL) implant, is that the TL implant has an internal conical connection, while

Sponsors

Yonsei University Health System, Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: ? 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

Design outcomes

Primary

MeasureTime frame
bone level (radiological evaluation)

Secondary

MeasureTime frame
Implant Stability Test (IST);Periotest value (PTV)

Countries

Korea, Republic of

Contacts

Public ContactYISEUL CHOI

Yonsei University Health System, Dental Hospital

loa@yuhs.ac+82-2-2228-2962

Outcome results

None listed

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