Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00646113
First received: March 25, 2008
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.


Condition Intervention
Jaw, Edentulous, Partially
Device: OsseoSpeed™

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Prospective, Single Arm, Multi-centre Study Evaluating Osseospeed™ Implant 3 mm Diameter Replacing a Central or Lateral Mandibular Incisor or Lateral Maxillary Incisor. A 5-year Follow-up Study.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Implant survival after 5 years [ Time Frame: 5 years after implant placement ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: March 2008
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OsseoSpeed™
    OsseoSpeed™ 3.0 mm diameter
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent
  • Aged 18-70 years at enrolment
  • History of edentulism in the study area of at least two months
  • Presence of natural tooth roots adjacent to the study implant position
  • Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
  • Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

  • Unlikely to be able to comply with study procedures, as judged by the investigator
  • Uncontrolled pathologic processes in the oral cavity
  • Known or suspected current malignancy
  • History of radiation therapy in the head and neck region
  • History of chemotherapy within 5 years prior to surgery
  • Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
  • Uncontrolled diabetes mellitus
  • Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
  • Smoking more than 10 cigarettes per day
  • Present alcohol and/or drug abuse
  • Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
  • Previous enrolment in the present study
  • Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrolment
  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: NCT00646113

Locations
Denmark
Tand-mund-kaebekirurgisk Klinik
Copenhagen, Denmark, 2100
Germany
Bundeswehrkrankenhaus
Ulm, Germany, D-89081
Italy
Clinica Odontoiatrica
Milano, Italy, 20123
Spain
Department Oral Surgery, University of Granada: School of Dentistry
Granada, Spain, 18071
Sweden
Käkkirurgiska kliniken, Odontologiska Institutionen
Jönköping, Sweden, 551 11
United Kingdom
Bristol Dental Hospital and School
Bristol, United Kingdom, BS1 2LY
Sponsors and Collaborators
Dentsply Implants
Investigators
Principal Investigator: Pablo Galindo Moreno, Assoc. Prof. University of Granada: School of Dentistry
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00646113     History of Changes
Other Study ID Numbers: YA-NAR-0001
Study First Received: March 25, 2008
Last Updated: January 9, 2014
Health Authority: Denmark: Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on July 24, 2014