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

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ClinicalTrials.gov Identifier: NCT00746187
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : April 16, 2014
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Dentsply Sirona Implants

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2002
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Marginal Bone Level Changes [ Time Frame: 3 years after implant placement (baseline) ]
    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 (baseline). Positive value indicates bone gain and negative value bone loss.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746187


Locations
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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 Sirona Implants
Investigators
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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
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Responsible Party: Dentsply Sirona Implants
ClinicalTrials.gov Identifier: NCT00746187    
Other Study ID Numbers: YA-MIC-0003
First Posted: September 3, 2008    Key Record Dates
Results First Posted: April 16, 2014
Last Update Posted: April 13, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
 Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases