Study Stopped
As of 2017 study was terminated since investigators retired. No subjects recruited.
Case Series Evaluation of a Short Dental Implant
Short implant
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2008
Longer than P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 24, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMay 30, 2017
May 1, 2017
5.8 years
November 24, 2008
May 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is implant loss (failure).
6 months and 1, 2 and 3 years after implant loading of the temporary prosthesis
Secondary Outcomes (1)
Secondary outcome measure include: mobility, implant stability, peri-implant radiolucency, signs/symptoms of pain or infection, radiographically measured bone loss and patient adaptation.
6 months, 1, 2, and 3 years after implant loading
Study Arms (1)
1
OTHERa 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.
Interventions
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: 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
Eligibility Criteria
You may qualify if:
- Provision of written informed consent
- 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 premolar.
- Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading
You may not qualify if:
- 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, within 2 months, in the planned implant area.
- Alveolar bone height of \< than 5 mm from the alveolar crest to the floor of the maxillary sinus, 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 Subjects who require routine antibiotic use for SBE
- Pregnancy or lactation at the time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clark Stanfordlead
Study Sites (1)
University of Iowa College of Dentistry
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 24, 2008
First Posted
November 25, 2008
Study Start
October 1, 2008
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
May 30, 2017
Record last verified: 2017-05