A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading
This study is currently recruiting participants.
Verified April 2012 by Dentsply Implants
Sponsor:
Dentsply Implants
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01340170
First received: April 21, 2011
Last updated: April 24, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | April 21, 2011 | ||||
| Last Updated Date | April 24, 2012 | ||||
| Start Date ICMJE | April 2011 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Marginal bone level [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ] Marginal Bone Level alterations will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01340170 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading | ||||
| Official Title ICMJE | An Open, Non-randomized, Prospective Multi-centre Study Evaluating a Soft Bone Drilling Protocol for Single Tooth Restoration in the Posterior Area With Immediate Loading | ||||
| Brief Summary | The study objective is to establish that there is no statistical difference in marginal bone level change comparing a Standard drilling protocol with a Soft bone drilling protocol when using OsseoSpeed TX and immediate loading. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Edentulism | ||||
| Intervention ICMJE | Device: OsseoSpeed TX
OsseoSpeed TX dental implants, 6-17 mm |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 138 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01340170 | ||||
| Other Study ID Numbers ICMJE | YA-OTX-0002 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Dentsply Implants | ||||
| Study Sponsor ICMJE | Dentsply Implants | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Dentsply Implants | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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