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Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00746187
First received: September 2, 2008
Last updated: March 12, 2014
Last verified: March 2014
History of Changes
  Purpose

The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.


Condition Intervention
Jaw, Edentulous, Partially
 Device: ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Marginal Bone Level Changes [ Time Frame: 3 years after implant placement ] [ 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 the 3-year follow-up visit were compared to values obtained at Implant placement. Positive value indicates bone gain and negative value bone loss.
Enrollment: 36
Study Start Date: December 2002
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASTRA TECH Implant System; Fixture ST
Ø 4.5 cm in lengths 9-13 mm
 Device: ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
Experimental: Biomet 3i; Osseotite® Implants
Ø 4.0 cm in lengths 8.5-13 mm
 Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Age 18 - 75 years
  • Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
  • Edentulous in the area/s if implant placement for more than 2 months

Exclusion Criteria:

  • Untreated caries and/or periodontal disease of residual dentition
  • Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
  • Absence of occlusal stability in centric occlusion
  • Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
  • Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
  • Pregnancy
  • Present alcohol or drug abuse
  • Tobacco smoking during the last 6 months
  • Unable or unwilling to return for follow-up visits for a period of 3 years
  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: NCT00746187

Locations
United States, New York
Dept. of Implant Dentistry, New York University
New York, New York, United States, 10010
United States, North Carolina
Dept. of Prosthodontics, School of Dentistry, University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7450
Sponsors and Collaborators
Dentsply Implants
Investigators
Principal Investigator: Dennis P Tarnow, D.D.S. Prof. Dept. of Implant Dentistry, New York University (to March 2011)
Principal Investigator: Stuart Froum, Dr Dept. of Implant Dentistry, New York University (from March 2011)
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00746187     History of Changes
Other Study ID Numbers: YA-MIC-0003
Study First Received: September 2, 2008
Results First Received: March 12, 2014
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015