Presenting with a single-tooth edentulous spacein the mandibular molar region.
Conditions
Interventions
Following one-stage placement of a buttress-threaded dental implant (FINESIA BL Fixture BE), a provisional prosthetic restoration was delivered within the same day to one week postoperatively.
Sponsors
Eriko Marukawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be enrolled in this clinical study: 1)Patients presenting with a single-tooth edentulous space in the mandibular molar region and who desire dental implant treatment. 2)Patients with sufficient bone width and height at the planned implant site (i.e., post-extraction healing is adequate and bone augmentation is not required). 3)Patients aged 20 years or older and younger than 80 years at the time of obtaining informed consent. 4)Patients who have received a thorough explanation of the study, fully understood its contents, and voluntarily provided written informed consent.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this clinical study: 1)Patients with a bleeding tendency. 2)Patients with metabolic or endocrine disorders that may significantly affect postoperative bone formation (e.g., osteoporosis, patients undergoing hemodialysis). 3)Patients currently receiving bone resorption inhibitors (e.g., bisphosphonates, denosumab). 4)Patients receiving systemic steroid therapy that may affect postoperative tissue healing (excluding topical formulations such as eye drops, nasal sprays, and other external applications). 5) Patients with poorly controlled diabetes (patients with HbA1c of 7.0 or higher). 6) Patients with severe bruxism. 7) Patients with poor oral hygiene (patients with PCR of 20% or higher). 8) Patients who are current smokers. 9) Patients with a confirmed allergy to the metal components contained in the research device material (titanium alloy). 10) Patients with a history of radiation therapy in the planned implant site. 11) Patients with excessive expectations for implant treatment. 12) Patients with a history of poor outcomes from implant treatment. 13) Patients without immobile keratinized mucosa in the planned implant site. 14) Patients requiring dental treatment of adjacent teeth. 15) Patients with serious cardiovascular disease, such as myocardial infarction. 16) Patients for whom appropriate postoperative care is difficult, such as those with the following conditions: (dementia or other mental disorders, drug addiction, alcoholism) 17) Pregnant or lactating patients. 18) Patients undergoing treatment for malignant neoplasms. 19) Other patients who the investigator judges to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant survival rate at 60 weeks following implant placement surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Implant survival rates at 10 days, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks and 48 weeks following implant placement surgery. 2)Marginal bone resorption around the implant assessed by standardized periapical radiography. 3)Peri-implant bone resorption assessed by dental cone-beam computed tomography (CBCT) 4)Implant Stability Quotient (ISQ) values 5)Patient satisfaction assessed using the Oral Health Impact Profile-14 (OHIP-14) 6)Plaque Index (PLI) 7)Probing pocket depth 8)Gingival Index (GI) | — |
Contacts
Public ContactShimogishi Masahiro
Institute of Science Tokyo Hospital
Outcome results
None listed