CompletedNot Applicable

Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed

Sweden107 participantsStarted 2011-03

Plain-language summary

To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX

Age range18 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.

✓. Provision of informed consent
✓. Female/male aged 18 years and over
✓. History of edentulism in the study area of at least 3 months
✓. In need for implant(s) replacing missing tooth/teeth in the maxilla
✓. Deemed by the investigator to be suitable for one stage surgery
✓. Deemed by the investigator to be suitable for loading after 10-12 weeks
✓. Deemed by the investigator as likely to present an initially stable implant situation.
✓. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.

✕. Unlikely to be able to comply with study procedures, as judged by the investigator
✕. Uncontrolled pathological processes in the oral cavity
✕. Known or suspected current malignancy
✕. History of radiation therapy in the head and neck region
✕. History of chemotherapy within 5 years prior to surgery
✕. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
✕. Uncontrolled diabetes mellitus
✕. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration

Marginal Bone Level

Timeframe: One year after loading

NCT IDNCT01324778

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12