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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

September 2, 2008
March 12, 2014
December 2002
June 2011   (final data collection date for primary outcome measure)
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.
Changes in marginal bone level. [ Time Frame: At follow-up visits: 6 months, 1 year, 2 and 3 years after implants have been loaded ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00746187 on ClinicalTrials.gov Archive Site
Not Provided
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Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
  • Experimental: ASTRA TECH Implant System; Fixture ST
    Ø 4.5 cm in lengths 9-13 mm
    Intervention: 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
    Intervention: Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00746187
YA-MIC-0003
No
Dentsply Implants
Dentsply Implants
Not Provided
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)
Dentsply Implants
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP