None listed
Conditions
Interventions
Medical Device :
The survival rate at 12 months after the treatment of dental implant fixtures with the same medical device design but different materials is evaluated.
Sponsors
Osstem Implant
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who are 19 years of age or older and whose jaw bone growth has been completed 2. Those who are scheduled to place implants for restoration of esthetic and masticatory function due to one or three consecutive natural tooth defects in the upper and lower premolars or molars 3. Those who have passed the proper anatomical structure and dental condition for implant placement (At least one tooth defect site must satisfy all of the following criteria.) ?When an antagonist (including natural teeth or implant-fixed prosthesis) exists and implant placement is not scheduled on the antagonist or adjacent teeth during the follow-up period ?When the anatomical structure of the tooth defect on the CBCT image is suitable for implant placement ?When there is minimal bone quality and bone mass to ensure initial implant fixation on CBCT image ?If maxillary elevation is required, the amount of bone remaining to the base of the maxillary sinus on the apical radiographic image must be at least 5 mm. 4. Those who voluntarily decided to participate in this clinical trial and gave their written consent to the subject consent form 5. A person who adheres to visits during the specified follow-up period and is willing to comply with the clinical trial protocol
Exclusion criteria
Exclusion criteria: If any of the following exclusion criteria are met, you cannot participate in this clinical trial. 1.Those who smoke more than 20 cigarettes a day 2.Those who have bad oral habits such as severe bruising and clenching 3.Those who have contraindications to oral procedures (eg, insufficient wound healing ability, unhygienic oral conditions, dry mouth) 4.Those who have been taking drugs that may affect bone metabolism continuously for 7 days or more within the last 6 months (eg. Bisphosphonates, Corticosteroids) 5.Those who are immunocompromised (Those who are receiving immunosuppressive drugs, anticancer drugs, etc.) 6.Those who have undergone bone augmentation or socket graft in the tooth defect within 6 months of the procedure 7.Those with local mucosa-related diseases (eg, lichen planus erosive) in or around the tooth defect (adjacent teeth, antagonists) 8.Those who have a lesion such as a tumor or osteomyelitis at the site of a tooth defect or elsewhere in the oral cavity, or have previously had surgery to remove it 9.Patients with uncontrolled systemic disease (eg diabetes, osteomalacia, thyroid disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant success rate at 12 months after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Implant success rate at 6 months after the procedure;Implant survival rate at 6 and 12 months after the procedure;Loss of marginal bone around the implant at 6 and 12 months after the procedure;Evaluation of the soft tissue condition around the implant at 6 and 12 months after the procedure | — |
Countries
Korea, Republic of
Contacts
Public ContactNA HEE JANG
Seoul National University Bundang Hospital
Outcome results
None listed