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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00711022
First received: July 7, 2008
Last updated: July 4, 2014
Last verified: May 2014
  Purpose

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 Intervention
Jaw, Edentulous
Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Implant Survival Rate [ Time Frame: At 5-year follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 51
Study Start Date: May 2005
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OsseoSpeed Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711022

Locations
United States, Illinois
The University of Chicago, MC-2108
Chicago, Illinois, United States, 60637
Sweden
Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Dentsply Implants
Investigators
Principal Investigator: Joseph A Toljanic, Prof. University of Chicago
  More Information

Publications:
Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00711022     History of Changes
Other Study ID Numbers: YA-OSS-0008
Study First Received: July 7, 2008
Results First Received: March 12, 2014
Last Updated: July 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Sweden: Regional Ethical Review Board

Keywords provided by Dentsply Implants:
Jaw, Edentulous (maxilla, with poor bone quality and quantity)

Additional relevant MeSH terms:
Jaw, Edentulous
Mouth, Edentulous
Jaw Diseases
Mouth Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 23, 2014