Short Implants - An Alternative to Bone Grafting?

Completed · Not applicable

Conditions studied: Jaw, Edentulous, Partially

In brief

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

Key facts

Study ID

NCT01030523

Run by

Dentsply Sirona Implants and Consumables

People needed

101

Starts

2009-10-01

Expected to finish

2022-03-22

Last updated by the study team

2023-04-06

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Oral Rehabilitation, Skeletal Development and Biomaterials, University of Connecticut, School of Dental Medicine — Farmington, Connecticut, United States
• Ärztegesellschaft für Zahn- Mund- und Kieferheilkunde, Akademie für Orale Implantologie: Fürhauser, Haas, Mailath-Pokorny & Watzek OG — Vienna, Austria
• Aesthetic Dent — Szczecin, Poland
• Facultad de Medicina y Odontologia, Universidade de Santiago de Compostela — Santiago de Compostela, Spain
• Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich — Zurich, Switzerland

Full record on ClinicalTrials.gov

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