Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours
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The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial teeth are attached within 24 hours. The primary objective is to investigate implant survival rate.
Condition or disease
Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
An Open, Prospective, Multicenter Study to Evaluate the Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants, in Patients With Totally Edentulous Maxillas and Poor Bone Quality and Quantity in an Immediate Loading Protocol.
Implant Survival Rate [ Time Frame: At 5-year follow-up ]
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
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Ages Eligible for Study:
20 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Provision of informed consent
Aged 20 years and over
History of totally edentulous maxilla of at least three months
Radiographic finding indicating bone quality class 3 or 4 (Lekholm and Zarb) in the maxilla
Radiographic finding indicating bone quantity class C, D or E (Lekholm and Zarb) in the maxilla
Presence of natural teeth, partial prosthesis and/or implants in the mandible, within positions 35-45 (according to the FDI digit system)
Deemed by the investigator as likely to present an initially stable implant situation suitable for immediate loading.
Unlikely to be able to comply with study procedures, as judged by the investigator
Uncontrolled pathologic processes in the oral cavity
Known or suspected current malignancy
History of radiation 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
History of bone augmentation in the maxilla within 6 months prior to surgery
Known pregnancy at time of enrolment
Present alcohol and/or drug abuse
Current use of tobacco or history of tobacco use within 6 months prior to surgery