- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01510470
Clinical and Radiological Outcomes Study on Astra Tech Osseospeed Tx Profile Implant
January 13, 2012 updated by: Dr. Philip Lee KM, Hong Kong Brånemark Osseointegration Center
The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site maintains the marginal bone level
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong SAR, China
- Hong Kong Brånemark Osseointegration Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with single missing maxillary or mandibular premolar or molar
Description
Inclusion Criteria:
- Patients with single missing maxillary or mandibular premolar or molar
- The edentulous sites should be healed sites
- The opposing tooth will be a natural dentition
Exclusion Criteria:
- general contraindications to dental implant surgery
- Patient with irradiation in the head and neck region
- Immuno-suppressed or immuno-compromised patients
- Patients who took or are taking amino-bisphosphonates
- Patients with poor oral hygiene and motivation
- Patients with untreated periodontitis
- Uncontrolled diabetes
- Pregnancy or lactation
- Addiction to alcohol or other drugs
- patients with psychiatric problems
- Lack of occluding dentition/prosthesis
- Restricted mouth opening (less than 3.5cm inter-arch anteriorly)
- Patients with an acute or chronic infection/inflammation in the area intended for implant placement
- Patients unable to commit 5 years follow up
- Patients referred for implant placement only
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
January 11, 2012
First Submitted That Met QC Criteria
January 13, 2012
First Posted (Estimate)
January 16, 2012
Study Record Updates
Last Update Posted (Estimate)
January 16, 2012
Last Update Submitted That Met QC Criteria
January 13, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2011028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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