Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours
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.
1 other identifier
interventional
51
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2005
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
May 13, 2014
CompletedJuly 16, 2014
May 1, 2014
6.8 years
July 7, 2008
March 12, 2014
July 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implant Survival Rate
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.
At 5-year follow-up
Study Arms (1)
OsseoSpeed
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The University of Chicago, MC-2108
Chicago, Illinois, 60637, United States
Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine
Uppsala, SE-751 85, Sweden
Related Publications (4)
Toljanic JA, Baer RA, Ekstrand K, Thor A. Implant rehabilitation of the atrophic edentulous maxilla including immediate fixed provisional restoration without the use of bone grafting: a review of 1-year outcome data from a long-term prospective clinical trial. Int J Oral Maxillofac Implants. 2009 May-Jun;24(3):518-26.
PMID: 19587876RESULTErkapers M, Ekstrand K, Baer RA, Toljanic JA, Thor A. Patient satisfaction following dental implant treatment with immediate loading in the edentulous atrophic maxilla. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):356-64.
PMID: 21483889RESULTThor A, Ekstrand K, Baer RA, Toljanic JA. Three-year follow-up of immediately loaded implants in the edentulous atrophic maxilla: a study in patients with poor bone quantity and quality. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):642-9. doi: 10.11607/jomi.3163.
PMID: 24818203RESULTErkapers M, Segerstrom S, Ekstrand K, Baer RA, Toljanic JA, Thor A. The influence of immediately loaded implant treatment in the atrophic edentulous maxilla on oral health related quality of life of edentulous patients: 3-year results of a prospective study. Head Face Med. 2017 Nov 10;13(1):21. doi: 10.1186/s13005-017-0154-0.
PMID: 29126426DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Manager Global Clinical Research
- Organization
- DENTSPLY Implants
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph A Toljanic, Prof.
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2008
First Posted
July 8, 2008
Study Start
May 1, 2005
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 16, 2014
Results First Posted
May 13, 2014
Record last verified: 2014-05