Study on OsseoSpeed™ TX Implants in a Chinese Population (NCT01346683) | Clinical Trial Compass
CompletedNot Applicable
Study on OsseoSpeed™ TX Implants in a Chinese Population
China45 participantsStarted 2011-02
Plain-language summary
To investigate the clinical efficacy of OsseoSpeed™ TX implants 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 posterior mandible is a safe and predictable procedure.
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“. Aged 20-75 years at enrolment
âś“. History of edentulism in the posterior mandible, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
âś“. Neighboring tooth to the planned bridge must have natural root.
âś“. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
âś“. Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 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•. Current need for pre-surgical bone or soft tissue augmentation in the planned implant 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 3 years after implant loading