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Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00711113
First received: July 7, 2008
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Jaw, Edentulous, Partially
Device: OsseoSpeed™

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Implant Survival Rate [ Time Frame: At 5 year follow-up ] [ Designated as safety issue: No ]
    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.

  • Implant Stability [ Time Frame: At 1 year follow-up ] [ Designated as safety issue: No ]
    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.

  • Marginal Bone Adaptation [ Time Frame: At baseline (loading) and at 5 year follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 47
Study Start Date: December 2003
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: OsseoSpeed™
OsseoSpeed™, all dimensions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  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: NCT00711113

Locations
United States, Iowa
University of Iowa, College of Dentistry, Dow's Institute for Dental Research
Iowa City, Iowa, United States, 52242-1010
United States, Texas
UTHSCSA
San Antonio, Texas, United States, 78229
Germany
Universitetsklinik Mainz, Klinik fur ZMK
Mainz, Germany, D-551 31
Sponsors and Collaborators
Dentsply Implants
Investigators
Principal Investigator: James T Mellonig, D.D.S., M.S University of Texas
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00711113     History of Changes
Other Study ID Numbers: YA-OSS-0001
Study First Received: July 7, 2008
Results First Received: August 22, 2013
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Ethics Commission

Keywords provided by Dentsply Implants:
Jaw, Edentulous, Partially (posterior maxilla)

Additional relevant MeSH terms:
Jaw, Edentulous
Mouth, Edentulous
Jaw Diseases
Mouth Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on November 20, 2014