Multicenter, single-blind(subjects), prospective, randomized, comparative, pivotal study, to evaluate the efficacy and safety of a special material dental implant fixture 'WPM-TSIII SA fixture' with ‘TSIII SA Fixture’, for patients requiring implant placement to restore esthetics and masticatory function due to tooth defects

Osstem Implant0 个研究点目标入组 80 人开始时间: 待定最近更新: 2022年1月11日

试验速览

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•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
•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

•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)

发起方

Osstem Implant