Study on Short Implants (OsseoSpeed™) Compared to Standard Length Implants (OsseoSpeed™) With Bone Substitution
This study is ongoing, but not recruiting participants.
Sponsor:
Dentsply Implants
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01030523
First received: December 10, 2009
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
The Study is on short implants (OsseoSpeed™) compared 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: OsseoSpeed™ 4.0 S (length: 6 mm) Device: 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 Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Short Implants
OsseoSpeed™ 4.0 S (length: 6 mm)
|
Device: OsseoSpeed™ 4.0 S (length: 6 mm)
OsseoSpeed™ 4.0 S (length: 6 mm)
|
|
Active Comparator: Long Implants
OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
|
Device: OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
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
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: | February 25, 2013 |
| 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 May 19, 2013