Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw
This study is ongoing, but not recruiting participants.
Sponsor:
Dentsply Implants
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00646113
First received: March 25, 2008
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.
| Condition | Intervention |
|---|---|
|
Jaw, Edentulous, Partially |
Device: OsseoSpeed™ |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open, Prospective, Single Arm, Multi-centre Study Evaluating Osseospeed™ Implant 3 mm Diameter Replacing a Central or Lateral Mandibular Incisor or Lateral Maxillary Incisor. A 5-year Follow-up Study. |
Further study details as provided by Dentsply Implants:
Primary Outcome Measures:
- Implant survival after 5 years [ Time Frame: 5 years after implant placement ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: OsseoSpeed™
OsseoSpeed™ 3.0 mm diameter
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of informed consent
- Aged 18-70 years at enrolment
- History of edentulism in the study area of at least two months
- Presence of natural tooth roots adjacent to the study implant position
- Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
- 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
- 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, as deemed by the investigator
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes per day
- 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, or participation in a clinical study during the last weeks prior to enrolment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646113
Locations
| Denmark | |
| Department of Oral and Maxillofacial Surgery | |
| Glostrup, Denmark, 2600 | |
| Germany | |
| Bundeswehrkrankenhaus | |
| Ulm, Germany, D-89081 | |
| Italy | |
| Clinica Odontoiatrica | |
| Milano, Italy, 20123 | |
| Spain | |
| Department Oral Surgery, University of Granada: School of Dentistry | |
| Granada, Spain, 18071 | |
| Sweden | |
| Käkkirurgiska kliniken, Odontologiska Institutionen | |
| Jönköping, Sweden, 551 11 | |
| United Kingdom | |
| Bristol Dental Hospital and School | |
| Bristol, United Kingdom, BS1 2LY | |
Sponsors and Collaborators
Dentsply Implants
Investigators
| Principal Investigator: | Pablo Galindo Moreno, Assoc. Prof. | University of Granada: School of Dentistry |
More Information
No publications provided
| Responsible Party: | Dentsply Implants |
| ClinicalTrials.gov Identifier: | NCT00646113 History of Changes |
| Other Study ID Numbers: | YA-NAR-0001 |
| Study First Received: | March 25, 2008 |
| Last Updated: | February 22, 2013 |
| Health Authority: | Denmark: Ethics Committee Germany: Ethics Commission Italy: Ethics Committee Spain: Ethics Committee Sweden: Regional Ethical Review Board United Kingdom: Research Ethics Committee |
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