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Sponsored by: |
University of Iowa |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00798031 |
Following the loss of teeth, the alveolar bone formed in response to the eruption of the teeth is gradually resorbed by the body. In conventional dental implant therapy, a wide safety margin of uninterrupted healing (3-6 months) following placement of the implants is used to assure a predictable survival of the implants (on the order of > 90%). In the past few years, there have been multiple studies documenting with improved implant surface technologies available, that dental implants can be put into function far sooner than conventionally thought. The investigators are currently performing recalls on subjects treated in a research protocol at the University of Iowa (YAOSS-0001; IRB 200305001). Since this initial study, a shortened version of the implant device has been developed and has obtained FDA clearance (FDA 510k 063779 clearance letter dated April 27, 2007) for a 4mm diameter by 6mm in length dental implant. In a case study the investigators are proposing to repeat the same protocol as used in the initial trial with the following exceptions: only this one implant type will be used, no bone compression surgical techniques will be used (referred to as "osteotome" indirect sinus lifting). Our initial trial has documented good performance with minimal bone loss and a 98.3% cumulative survival rate.
This will be an open, prospective case-series clinical documentation study to document the clinical efficacy of the 4.0mm diameter x 6 mm in length implant (Astra Tech Dental Implant, Fixture OsseospeedTM ) in the treatment of subjects missing teeth in the upper jaw. A minimum of two but preferably three implants shall be considered for each surgical site. A total of 20 subjects fulfilling all inclusion criteria will be enrolled. Subjects will have a complete diagnostic work-up performed and assessment for eligibility in the study by both a Prosthodontist and Surgeon. Subjects will then have the implants placed in an out patient basis at the College of Dentistry. The subjects will not wear a conventional removable partial during the initial six weeks of healing. At six weeks, an assessment of the implants shall be made by the surgical and restorative team and if a set of safety benchmarks are met, provisional crowns will be made to place the implants into clinical function (mastication). Over the first year, the provisional crowns will be periodically removed and a series of clinical measurements and mobility measurements made. At the end of 1 year following placement, the permanent crowns or bridgework will be constructed and the subject followed annually for another four years (five years total from placement). A total of 15 clinical visits are estimated per subject.
Condition | Intervention | Phase |
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Tooth Loss |
Device: A minimum of two but up to three Astra Tech Dental Implant, Fixture Osseospeed will be placed in the posterior upper jaw of 20 eligible subjects. Device: Placement of dental implant Device: dental implant |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Case Series Evaluation of a Short Dental Implant Placed in the Posterior Maxilla in an Early Loading Protocol |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | August 2014 |
Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
a minimum of two dental implants, but up to 3 dental implants, will be placed in each of 20 subjects. All surgical procedures will be performed as outpatient procedures at the College of Dentistry and implant placement will follow a one-stage procedure under local anesthesia. Placement of the 2-3 dental implants is the only intervention.
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Device: A minimum of two but up to three Astra Tech Dental Implant, Fixture Osseospeed will be placed in the posterior upper jaw of 20 eligible subjects.
A minimum of 2 but up to three dental implants will be placed in the posterior upper jaw of 20 subjects. The dental implants are produced by Astra Tech AB (Fixture Micro Thread OsseoSpeed TM Astra Tech AB. The study will include 15 clinic visits and interim analysis will occur at 6 months, 1, 2, and 3 years after loading of the temporary prosthesis.
Device: Placement of dental implant
Device: A minimum of two but up to three Astra Tech Dental Implant, Fixture Osseospeed will be placed in the posterior upper jaw of 20 eligible subjects. A minimum of 2 but up to three dental implants will be placed in the posterior upper jaw of 20 subjects. The dental implants are produced by Astra Tech AB (Fixture Micro Thread OsseoSpeed TM Astra Tech AB. the study will include 15 clinic visits and interim analysis will occur at 6 months, 1, 2, and 3 years after loading of the temporary prothesis.
Subjects will have a complete diagnostic work-up performed and assessment for eligibility in the study by both a Prosthodontist and Surgeon. Subjects will then have two and up to three dental implants placed in an out patient basis at the University of Iowa College of Dentistry
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cynthia Asmussen, RA-II | 319-335-7377 | cynthia-aasmussen@uiowa.edu |
Contact: Thomas Flynn, BGS | 319-335-6763 | thomas-flynn@uiowa.edu |
United States, Iowa | |
University of Iowa College of Dentistry | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Principal Investigator: Calrk Stanford, DDS, PhD | |
Sub-Investigator: Christopher Barwacz, DDS |
Responsible Party: | The University of Iowa College of Dentsitry ( Clark Stanford, DDS, PhD ) |
Study ID Numbers: | IIS replication of YA-OSS-0001 |
Study First Received: | November 24, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00798031 |
Health Authority: | United States: Food and Drug Administration |
dental implant upper jaw posterior tooth loss short dental implant |
Adults, 18 years of age and older Missing a minimum of two posterior teeth in their upper jaw Subjects in need of dental implants the research study is survival and function of the implants |
Mouth Diseases Tooth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Loss |