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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646113
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Dentsply Sirona Implants

Brief Summary:
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 or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Device: OsseoSpeed™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2008
Actual Primary Completion Date : August 2014

Arm Intervention/treatment
Experimental: OsseoSpeed™
OsseoSpeed™ 3.0 mm diameter
Device: OsseoSpeed™
OsseoSpeed™ 3.0 mm diameter

Primary Outcome Measures :
  1. Implant survival after 5 years [ Time Frame: 5 years after implant placement ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00646113

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

Publications of Results:
Responsible Party: Dentsply Sirona Implants Identifier: NCT00646113     History of Changes
Other Study ID Numbers: YA-NAR-0001
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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