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:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01030523
First received: December 10, 2009
Last updated: March 17, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short Implants - An Alternative to Bone Grafting?

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Implant survival rate [ Time Frame: On a regular basis during 5 years follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Marginal bone level alterations [ Time Frame: On a regular basis during 5 years follow-up ] [ Designated as safety issue: No ]
  • Condition of periimplant mucosa [ Time Frame: On a regular basis during 5 years follow-up ] [ Designated as safety issue: No ]
  • Crown-to-implant ratio [ Time Frame: On a regular basis during 5 years follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: February 2017
Estimated 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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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 Implants
Investigators
Principal Investigator: Christoph Hämmerle, Prof. Dr. Dr. Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT01030523     History of Changes
Other Study ID Numbers: YA-SHO-0002
Study First Received: December 10, 2009
Last Updated: March 17, 2014
Health Authority: Austria: Ethikkommission
Poland: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Switzerland: Ethikkommission
United States: Institutional Review Board

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