Case Series Evaluation of a Short Dental Implant (Short implant)

This study has suspended participant recruitment.
(Recruitement currently suspended to allow project personnel to focus on other research. Recruitment should open in 2010.)
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00798031
First received: November 24, 2008
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

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
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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Case Series Evaluation of a Short Dental Implant Placed in the Posterior Maxilla in an Early Loading Protocol

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • The primary outcome measure is implant loss (failure). [ Time Frame: 6 months and 1, 2 and 3 years after implant loading of the temporary prosthesis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measure include: mobility, implant stability, peri-implant radiolucency, signs/symptoms of pain or infection, radiographically measured bone loss and patient adaptation. [ Time Frame: 6 months, 1, 2, and 3 years after implant loading ] [ Designated as safety issue: No ]

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
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.
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.
Other Names:
  • Astra Tech AB OsseoSpeed 4mm diameter - 6mm length dental implant
  • FDA510(k)number: K063779
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.

Other Names:
  • Astra Tech Dental Implant Fixture Osseospeed.
  • Dental implants are 4.00 mmdiameter x 6mm in length
Device: dental implant
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
Other Names:
  • 4.0mm diameter x 6 mm in length implant
  • (Astra Tech Dental Implant, Fixture OsseospeedTM)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 premolar.
  • 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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798031

Locations
United States, Iowa
University of Iowa College of Dentistry
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
  More Information

No publications provided

Responsible Party: Clark Stanford, DDS, PhD, The University of Iowa College of Dentsitry
ClinicalTrials.gov Identifier: NCT00798031     History of Changes
Other Study ID Numbers: IIS replication of YA-OSS-0001
Study First Received: November 24, 2008
Last Updated: June 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
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

Additional relevant MeSH terms:
Tooth Loss
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 21, 2014