Vertical Augmentation With Osteon at Dental Implant Placement
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 5, 2010 | ||||||||
| Last Updated Date | July 14, 2010 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The success of dental implants in alveolar bone augmented in the vertical direction with Osteon [ Time Frame: 3 years ] [ Designated as safety issue: No ] The implants will be deemed successful at each time point if the radiographic bone level remains at 2 mm above the level of the implant, i.e. at the same height as when placed. Given that we know precisely the dimensions of the abutments placed in the implant, this provides the necessary calibration in order to undertake this assessment. If the bone level is lost, the procedure will be deemed to have failed. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01162629 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Vertical Augmentation With Osteon at Dental Implant Placement | ||||||||
| Official Title ICMJE | An Evaluation of Vertical Augmentation of Alveolar Bone With Osteon at Dental Implant Placement | ||||||||
| Brief Summary | Dental implants are a valid and reliable method to replace missing teeth. The major requirement for their success is an adequate volume of bone into which they can be placed. One widely used method to augment bone at the time of placing the implant is to use a bone substitute rather than taking a block bone graft from the patient. Successful augmentation in the vertical direction has often proved difficult, however, the investigators have developed a technique to achieve this in the investigators patients using a synthetic bone substitute, Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another unnecessary surgical procedure. |
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| Detailed Description | Primary Objective • To determine the success of dental implants in alveolar bone augmented in the vertical direction with Osteon. Secondary Objectives • To determine the long term success of dental implants in this augmented bone. Primary Endpoint • Radiographically assessed vertical height of alveolar ridge formation following Osteon augmentation. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Private specialist dental implant clinic |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Osteon bone graft
Osteon bone substitute placed to a height of 2 mm above the top of the dental implant
Other Names:
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| Study Group/Cohort (s) | Osteon
Patients requiring dental implants with deficient alveolar bone height
Intervention: Device: Osteon bone graft |
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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 | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | September 2015 | ||||||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01162629 | ||||||||
| Other Study ID Numbers ICMJE | RED001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr Richard Oliver, Research and Education in Dentistry | ||||||||
| Study Sponsor ICMJE | Research and Education in Dentistry | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Research and Education in Dentistry | ||||||||
| Verification Date | July 2010 | ||||||||
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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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