None listed
Conditions
Interventions
Medical Device : The intervention group is divided into a test group and an active control group. The implant is placed at Visit 2, with the test group receiving the novel tapered implant with a long
Sponsors
Seoul National University Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult males and females, aged 20 years or older, with completed growth of the jaw, who are systemically amenable to surgical treatment of implant placement. 2) Subjects who require single-tooth implant placement to restore esthetic and masticatory function due to loss of one or more of the incisors or premolars of the upper or lower jaw. 3) Subjects with suitable anatomical structures and dental conditions for implant placement. - On CBCT image evaluation, there are no specific pathologies in the edentulous area and the anatomical structure is suitable for implant placement. 4) Subjects of antagonist teeth (either natural teeth or implant prosthesis). 5) Subjects who do not have plans for implant placement in adjacent teeth within 6 months following implant restoration. 6) Subjects who voluntarily consent to participate in the clinical trial and are willing and able to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1) General exclusion criteria (1) Women of childbearing potential. (2) Subjects with a history of myocardial infarction within the last 6 months. (3) Subjects with uncontrolled medical conditions (hypertension, diabetes, osteoporosis, thyroid disease). (4) Subjects with bleeding disorders. (5) Subjects with hypersensitivity to implant materials. (6) Subjects with a smoking habit of more than 20 cigarettes per day. (7) Subjects with dependence on alcohol or drugs. (8) Subjects whose participation in the study is deemed inappropriate by the researcher for ethical reasons or because it may affect the results of the study. 2) Dental-related exclusion criteria (1) Subjects with severe bruxism, clenching, or other harmful oral habits. (2) Subjects with contraindications for oral surgeries (e.g., inadequate wound healing capacity, poor oral hygiene, severe dry mouth). (3) Less than 8 weeks after tooth extraction. (4) Subjects requiring treatment in the edentulous area or its vicinity (adjacent teeth, antagonist teeth). - Have mucosal disease (e.g., lichen planus). - Presence of acute infection or active periodontitis or gingivitis. - Extensive bone loss due to periodontal disease requiring extraction of adjacent teeth. (5) Subjects with a history of bone grafting or alveolar ridge preservation at the edentulous area within 6 months of the procedure. (6) Subjects with abnormal occlusion in the posterior region. (7) Subjects with pathological conditions like tumors or osteomyelitis, or who have previously undergone removal surgery for such conditions in the edentulous area or elsewhere in the oral cavity. (8) Periodontal pocket depth of adjacent natural teeth exceeds 6 mm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| implant success rate | — |
Secondary
| Measure | Time frame |
|---|---|
| implant success rate;Implant stability;clinical examination;Clinician related outcome measurement;Subject related outcome measurement | — |
Countries
Korea, Republic of
Contacts
Public ContactHYUNYOUNG SONG
Seoul National University Dental Hospital
Outcome results
None listed