Study on OsseoSpeed™ TX Short Implants in a Chinese Population (NCT01346696) | Clinical Trial Compass
CompletedNot Applicable
Study on OsseoSpeed™ TX Short Implants in a Chinese Population
China45 participantsStarted 2011-02
Plain-language summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.
Who can participate
Age range20 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Provision of informed consent
âś“. Female and male aged 20-75 years at enrolment
âś“. In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
âś“. History of edentulism in the study area of at least four months
âś“. Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
âś“. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
âś“. Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm
âś“. Deemed by the investigator as likely to present an initially stable implant situation
Exclusion criteria
âś•. Unlikely to be able to comply with study procedures, as judged by the investigator
âś•. Earlier graft procedures in the study area
âś•. Uncontrolled pathologic processes in the oral cavity
âś•. Known or suspected current malignancy
âś•. History of radiation therapy in the head and neck region
What they're measuring
1
Marginal Bone Level Alteration
Timeframe: Evaluated from implant installation to 12 months after implant loading