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Study on ASTRA TECH Implant System, Short Implants (OsseoSpeed™) Compared to Standard Length Implants (OsseoSpeed™) With Bone Substitution

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01030523
First Posted: December 11, 2009
Last Update Posted: August 23, 2017
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.
Information provided by (Responsible Party):
Dentsply Sirona Implants
  Purpose

The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) with bone substitution.

The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.


Condition Intervention
Jaw, Edentulous, Partially Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm) Device: ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Implants - An Alternative to Bone Grafting?

Further study details as provided by Dentsply Sirona Implants:

Primary Outcome Measures:
  • Implant survival rate [ Time Frame: 5 years after permanent restoration ]

Secondary Outcome Measures:
  • Marginal bone level alterations [ Time Frame: 5 years after permanent restoration ]
  • Condition of periimplant mucosa [ Time Frame: 5 years after permanent restoration ]
  • Crown-to-implant ratio [ Time Frame: 1 year after permanent restoration ]

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: November 2021
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Short Implants
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
Active Comparator: Long Implants
ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
Device: ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent
  • Aged 20-75 years at enrolment
  • History of edentulism in the study area of at least four months
  • In need for 1-4 implants in either side of the posterior maxilla (premolar and molar region)
  • Neighboring tooth/teeth to the planned implant/s must have natural root(s) or implant supported restoration, with absence of pathology or excessive bone loss, as judged by the investigator
  • Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s
  • Deemed by the investigator to have a bone height between 5 and 7 mm and a bone width of a minimum of 6 mm
  • 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
  • Earlier bone graft procedures in the study area
  • 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
  • Uncontrolled diabetes mellitus
  • Corticosteroids, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration
  • Smoking more than 10 cigarettes/day
  • Bruxism
  • 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
  Contacts and Locations
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): NCT01030523


Locations
United States, Connecticut
Department of Oral Rehabilitation, Skeletal Development and Biomaterials, University of Connecticut, School of Dental Medicine
Farmington, Connecticut, United States, 06030
Austria
Ärztegesellschaft für Zahn- Mund- und Kieferheilkunde, Akademie für Orale Implantologie: Fürhauser, Haas, Mailath-Pokorny & Watzek OG
Wien, Austria, A-1090
Poland
Aesthetic Dent
Szczecin, Poland, P-71-403
Spain
Facultad de Medicina y Odontologia, Universidade de Santiago de Compostela
Santiago de Compostela, Spain, ES-15782
Switzerland
Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich
Zürich, Switzerland, CH-8032
Sponsors and Collaborators
Dentsply Sirona Implants
Investigators
Principal Investigator: Christoph Hämmerle, Prof. Dr. Dr. Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich
  More Information

Publications:
Responsible Party: Dentsply Sirona Implants
ClinicalTrials.gov Identifier: NCT01030523     History of Changes
Other Study ID Numbers: YA-SHO-0002
First Submitted: December 10, 2009
First Posted: December 11, 2009
Last Update Posted: August 23, 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