Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later
This study has been completed.
Sponsor:
Dentsply Implants
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00711425
First received: July 7, 2008
Last updated: December 12, 2011
Last verified: December 2011
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Purpose
The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior mandible in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.
| Condition | Intervention |
|---|---|
|
Jaw, Edentulous, Partially |
Device: OsseoSpeed™ |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Mandible in an Early Loading Protocol. |
Further study details as provided by Dentsply Implants:
Primary Outcome Measures:
- Implant Survival Rate [ Time Frame: At 5 year follow-up ] [ Designated as safety issue: No ]An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be reported as percentage of failed implants.
- Implant Stability [ Time Frame: At 1 year follow-up ] [ Designated as safety issue: No ]Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. Implants with a high primary stability (ISQ >65) appear to maintain a similar level of stability or to decrease somewhat in ISQ with time. Implants with a lower primary stability (ISQ 50-60) appear to display an increase in ISQ with time. Implants with low primary stability (ISQ <50) are more prone to failure. Implant stability changes over time will be determined by changes in absolute ISQ values.
- Marginal Bone Adaptation [ Time Frame: At 5 year follow-up ] [ Designated as safety issue: No ]Marginal bone adaptation will be expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visits will be compared to values obtained at Fixture Placement and Baseline.
| Enrollment: | 45 |
| Study Start Date: | February 2004 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Device: OsseoSpeed™
OsseoSpeed™, all dimensions
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of written informed consent
- 18 years of age and over
- Edentulous in the posterior mandible, Kennedy class I or class II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
- Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading
Exclusion Criteria:
- Untreated caries and/or periodontal disease of residual dentition
- History of edentulism in the area of implant placement of less than two months
- Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
- Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Present alcohol or drug abuse
- Unable or unwilling to return for follow-up visits for a period of 5 years
- Current use of smoking tobacco
- Pregnancy or lactation at the time of enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711425
Locations
| United States, Ohio | |
| The Ohio State University, College of Dentistry | |
| Columbus, Ohio, United States, 43210-1241 | |
| United States, Washington | |
| University of Washington, Dept. of Restorative Dentistry | |
| Seattle, Washington, United States, 98195 | |
| Germany | |
| Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie | |
| Göttingen, Germany, 37075 | |
Sponsors and Collaborators
Dentsply Implants
Investigators
| Principal Investigator: | Edwin A McGlumphy, D.D.S. | The Ohio State University, College of Dentistry |
More Information
Publications:
| Responsible Party: | Dentsply Implants |
| ClinicalTrials.gov Identifier: | NCT00711425 History of Changes |
| Other Study ID Numbers: | YA-OSS-0002 |
| Study First Received: | July 7, 2008 |
| Results First Received: | June 7, 2011 |
| Last Updated: | December 12, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Germany: Ethics Commission |
Keywords provided by Dentsply Implants:
|
Jaw, Edentulous, Partially (posterior mandible) |
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 June 18, 2013