Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01528215
First received: February 3, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.


Condition Intervention
Partial Edentulism in the Maxilla or in the Mandible.
Device: OsseoSpeed EV
Device: OsseoSpeed TX

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Prospective, Randomized, Multicenter Study Comparing OsseoSpeed™ EV With OsseoSpeed™ TX in Partially Edentulous Maxillae and Mandibles. A 5-year Follow-up Study.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Marginal Bone Level [ Time Frame: 12 months after implant loading ] [ Designated as safety issue: No ]
    Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).


Secondary Outcome Measures:
  • Marginal Bone Level [ Time Frame: 6 months after implant loading ] [ Designated as safety issue: No ]
    Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 6 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

  • Marginal Bone Level [ Time Frame: 24 months after implant loading ] [ Designated as safety issue: No ]
    Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 24 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

  • Marginal Bone Level [ Time Frame: 36 months after implant loading ] [ Designated as safety issue: No ]
    Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 36 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

  • Marginal Bone Level [ Time Frame: 48 months after implant loading ] [ Designated as safety issue: No ]
    Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 48 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

  • Marginal Bone Level [ Time Frame: 60 months after implant loading ] [ Designated as safety issue: No ]
    Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 60 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OsseoSpeed EV
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
Device: OsseoSpeed EV
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
Active Comparator: OsseoSpeed TX
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
Device: OsseoSpeed TX
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 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:

  1. Provision of Informed Consent.
  2. 18 -75 years at enrollment.
  3. In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
  4. History of edentulism in the planned implant area of at least 3 months (at Visit 2).
  5. At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
  6. Deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants.
  7. Deemed by the investigator to be suitable for loading after 6-8 weeks.
  8. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge.

Exclusion Criteria:

  1. Unlikely to be able to comply with study procedures, as judged by the investigator.
  2. Uncontrolled pathological processes in the oral cavity.
  3. Untreated, uncontrolled caries and/or periodontal disease.
  4. Known or suspected current malignancy.
  5. History of radiation therapy in the head and neck region.
  6. History of chemotherapy within 5 years prior to surgery.
  7. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration, as deemed by the investigator.
  8. Uncontrolled diabetes mellitus.
  9. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration.
  10. Smoking more than 10 cigarettes per day.
  11. Present alcohol and/or drug abuse.
  12. Current need for bone grafting and/or augmentation in the planned implant area. Local, minor soft tissue grafting will be allowed.
  13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site).
  14. Previous enrollment in the present study.
  15. Simultaneous participation in other clinical studies at enrollment (Visit 1) and during the subject's first year of this study.
  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: NCT01528215

Locations
United States, Iowa
Dows Institute for Dental Research, University of Iowa, College of Dentistry
Iowa City, Iowa, United States, 52242-1010
Belgium
University Hospital Ghent, Dental School Department Periodontology
Ghent, Belgium, 9000
Germany
Dep. of Prosthodontics, Goethe University
Frankfurt am Main, Germany, 605 90
Italy
Dental private practice, Denis Cecchinato
Padova, Italy, 351 25
Sponsors and Collaborators
Dentsply Implants
Investigators
Principal Investigator: Clark M Stanford, Prof Dows Institute for Dental Research, University of Iowa, College of Dentistry
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT01528215     History of Changes
Other Study ID Numbers: OTX-PLUS-0001
Study First Received: February 3, 2012
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board
Belgium: Ethics Committee
Italy: Ethics Committee
Germany: Ethics Commission

ClinicalTrials.gov processed this record on September 18, 2014