The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 10, 2010 | ||||||||
| Last Updated Date | March 10, 2010 | ||||||||
| Start Date ICMJE | May 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
bone height and density in former socket [ Time Frame: 3 months ] [ Designated as safety issue: No ] measured on CT |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
bone mineralization [ Time Frame: 3 months ] [ Designated as safety issue: No ] histology from bone in former socket |
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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 | The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | Simvastatin has been reported to promote osteoblastic activity and inhibit osteoclastic activity by enhancing the expression of BMP2. There have been many studies demonstrating the bone-promoting effect of local application various animal models including after application into socket of teeth in a rat. the purpose of the study is to investigate the effect of slow release topical simvastatin in socket of mandibular teeth on bone remodeling in the socket |
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| Detailed Description | after extraction of mandibular single root teeth 10 mg of slow release simvastatin would be inserted to the socket. observation will be at 1 week, 4 weeks and 3 months.after 3 months the patients will have dental CT as done routinely in our clinic before placing dental implants and the bone density and height will be measured on this data. during the procedure of inserting a dental implant a trephine will be taken for histology. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Hypercholesterolemia | ||||||||
| Intervention ICMJE | Drug: Simvastatin
10 mg simvastatin, slow release in socket of extracted tooth (single application only) |
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| Study Arm (s) |
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| Publications * | Wu Z, Liu C, Zang G, Sun H. The effect of simvastatin on remodelling of the alveolar bone following tooth extraction. Int J Oral Maxillofac Surg. 2008 Feb;37(2):170-6. Epub 2007 Sep 4. | ||||||||
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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 | 20 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | October 2010 (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 | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01085149 | ||||||||
| Other Study ID Numbers ICMJE | h123-HMO-CTIL | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | dr. casap nardi, hadassah medical organization, jerusalem, israel | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | March 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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