Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours

Completed · Not applicable

Conditions studied: Jaw, Edentulous

In brief

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.

Key facts

Study ID

NCT00711022

Run by

Dentsply Sirona Implants and Consumables

People needed

51

Starts

2005-05-01

Expected to finish

2012-03-01

Last updated by the study team

2014-07-16

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Need for interpreter

Where it is running

• The University of Chicago, MC-2108 — Chicago, Illinois, United States
• Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine — Uppsala, Sweden

Full record on ClinicalTrials.gov

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