- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00711113
Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later
January 9, 2014 updated by: Dentsply Sirona Implants and Consumables
An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Maxilla in an Early Loading Protocol.
The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol.
Primary objectives are implant stability, marginal bone adaptation and survival rate.
Study Overview
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
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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Mainz, Germany, D-551 31
- Universitetsklinik Mainz, Klinik fur ZMK
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Iowa
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Iowa City, Iowa, United States, 52242-1010
- University of Iowa, College of Dentistry, Dow's Institute for Dental Research
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Texas
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San Antonio, Texas, United States, 78229
- UTHSCSA
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of written informed consent
- 18 years of age and over
- Edentulous in the posterior maxilla, Kennedy classes I or II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
- Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading
Exclusion Criteria:
- Untreated caries and/or periodontal disease of residual dentition
- History of edentulism in the area of implant placement of less than two months
- Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
- Sinus floor thickness of less than 5 mm, verified by periapical radiographs.
- Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Present alcohol or drug abuse
- Unable or unwilling to return for follow-up visits for a period of 5 years
- Current use of smoking tobacco
- Pregnancy or lactation at the time of enrollment
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
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OsseoSpeed™, all dimensions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant Survival Rate
Time Frame: At 5 year follow-up
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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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At 5 year follow-up
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Implant Stability
Time Frame: At 1 year follow-up
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Implant stability was evaluated using Resonance Frequency Analysis (RFA).
The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.
The ISQ value indicates the level of stability.
Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability.
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At 1 year follow-up
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Marginal Bone Adaptation
Time Frame: At baseline (loading) and at 5 year follow-up
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Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant.
Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading).
Positive value indicates bone gain and negative value bone loss.
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At baseline (loading) and at 5 year follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: James T Mellonig, D.D.S., M.S, University of Texas
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
December 1, 2003
Primary Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
July 7, 2008
First Submitted That Met QC Criteria
July 7, 2008
First Posted (Estimate)
July 8, 2008
Study Record Updates
Last Update Posted (Estimate)
February 7, 2014
Last Update Submitted That Met QC Criteria
January 9, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YA-OSS-0001
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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