Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population (NCT01473355) | Clinical Trial Compass
CompletedNot Applicable
Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population
China45 participantsStarted 2011-10
Plain-language summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.
Who can participate
Age range20 Years – 75 Years
SexALL
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Inclusion criteria
âś“. Provision of informed consent
âś“. Aged 20-75 years at enrolment
âś“. History of edentulism in the study area of at least two months
âś“. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
âś“. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
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•. Uncontrolled pathologic processes in the oral cavity
âś•. Known or suspected current malignancy
âś•. History of radiation therapy in the head and neck region
âś•. History of chemotherapy within 5 years prior to surgery
âś•. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
âś•. Uncontrolled diabetes mellitus
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What they're measuring
1
Number of Survived Implants
Timeframe: Measured at the 3 year follow-up after implant loading.