None listed
Conditions
Interventions
Medical Device : Experimental: Onebody Zirconia implant
Comparator: Tissue level titanium implant
Sponsors
Vatechmcis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who are 19 years of age or older with completed maxillary and mandibular growth. 2. Individuals requiring single-tooth implants for the restoration of aesthetics and masticatory function due to the loss of one or two consecutive teeth in the upper or lower arch (FDI teeth numbers: 14-17, 24-27, 34-37, 44-47). 3. Individuals with appropriate anatomical structures and dental conditions for implant placement, meeting one of the following criteria: a. Presence of a natural tooth or implant-supported prosthesis in the target area, with no planned implant placement in the adjacent or target area during the observation period. b. Cone beam computed tomography (CBCT) assessment indicating anatomical suitability for implant placement in the area of tooth loss. 4. Have voluntarily signed the informed consent form before any study related procedures are performed. 5. Individuals willing to comply with visits during the observation period of this clinical trial and adhere to the clinical trial protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals with severe bruxism and similar oral habits 2. Individuals with contraindications for oral procedures (e.g., inadequate wound healing ability, insufficient interocclusal space, unhygienic oral conditions, oral dryness). 3. Individuals with unrecovered tooth extraction sites (e.g., less than 6 weeks since tooth extraction or with bone loss at the time of tooth extraction). 4. Individuals requiring treatment in the tooth loss area or its vicinity (e.g., mucosal diseases such as lichen planus, the presence of acute infection or active periodontitis or gingivitis, extensive bone loss due to periodontal disease requiring extraction of adjacent teeth). 5. Individuals with a history of bone augmentation or maxillary sinus lift surgery in the tooth loss area within the last 6 months. 6. Individuals with abnormal occlusion in the posterior teeth. 7. Individuals with tumors or pathologies such as osteomyelitis in the tooth loss area or other areas of the oral cavity or those who have undergone surgical removal in the past. 8. Individuals with a pocket depth of more than 7 mm in adjacent natural teeth. 9. Individuals with insufficient interocclusal space in the second molar area. 10. Individuals who smoke an average of 20 or more cigarettes per day. 11. Individuals with hypersensitivity reactions to implant materials (e.g., titanium, zirconia). 12. Individuals with a history of immunosuppressive conditions due to radiation or chemotherapy. 13. Individuals with uncontrolled systemic diseases (e.g., diabetes, osteoporosis, thyroid disorders). 14. Individuals with significant complications, including major cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, and neuro/psychiatric diseases. 15. Individuals with hemorrhagic disorders. 16. Individuals with a history of unexplained drug allergies. 17. Individuals with physical or mental disabilities interfering with proper oral hygiene. 18. Individuals with a history of or suspected drug or alcohol dependence. 19. Individuals who have received drugs affecting bone metabolism for 7 or more consecutive days within the last 6 months (e.g., bisphosphonate preparations). 20. Pregnant or lactating women. 21. In fertile women, those who do not agree to medically accepted contraceptive methods* during the clinical trial period. *Hormonal contraceptives, intrauterine devices (IUD or IUS), tubal ligation, double barrier methods (male condom, female condom, cervical cap, combined use of contraceptive barriers, and sponge), single barrier methods with concurrent use of spermicides. 22. Individuals currently participating in another clinical trial or who have participated in another clinical trial within 30 days of the screening date. 23. Other cases where the investigator deems participation in the clinical trial inappropriate due to ethical or potential impact on clinical trial results. ? Specific reasons are documented in the case record.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The implant success rate at 48 weeks post-surgery (N%) | — |
Secondary
| Measure | Time frame |
|---|---|
| The implant success rate at 24 weeks post-surgery (N%);The change in peri-implant marginal bone loss at 24 and 48 weeks post-surgery compared to the time of final prosthesis placement.;The implant survival rate at 24 and 48 weeks post-surgery (N%);The esthetic evaluation of implants at 24 and 48 weeks post-surgery (points);The peri-implant tissue status at 24 and 48 weeks post-surgery;The overall satisfaction of subjects with the implant procedure at 48 weeks post-surgery (points) | — |
Countries
Korea, Republic of
Contacts
Public ContactKyoung-hwa Kim
Seoul National University Dental Hospital
Outcome results
None listed