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The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth

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ClinicalTrials.gov Identifier: NCT01085149
Recruitment Status : Unknown
Verified March 2010 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : March 11, 2010
Last Update Posted : March 11, 2010
Sponsor:
Information provided by:
Hadassah Medical Organization

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Simvastatin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : May 2010
Estimated Primary Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: study group
simvastatin will be inserted to sockets
Drug: Simvastatin
10 mg simvastatin, slow release in socket of extracted tooth (single application only)
No Intervention: control
sockets will be left to healing without material in socket
Drug: Simvastatin
10 mg simvastatin, slow release in socket of extracted tooth (single application only)



Primary Outcome Measures :
  1. bone height and density in former socket [ Time Frame: 3 months ]
    measured on CT


Secondary Outcome Measures :
  1. bone mineralization [ Time Frame: 3 months ]
    histology from bone in former socket



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • need extraction of single root tooth
  • intend to have prosthetic implant in place of extraction

Exclusion Criteria:

  • treated with simvastatin P.O for hypercholesterolemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085149


Contacts
Contact: casap nardi, MD, DMD 00 972 2 6776148 ext 2 nard@md.huji.ac.il
Contact: rushinek heli, DMD 00 972 2 6776148 ext 2 heliru@walla.com

Locations
Israel
Oral and Maxillofacial Clinic, Hadassah Not yet recruiting
Jerusalem, Israel, 91120
Contact: casap nardi, MD, DMD    00 972 2 6776148 ext 2    nard@md.huji.ac.il   
Contact: rushinek heli, DMD    00 972 26776148 ext 2    heliru@walla.com   
Principal Investigator: casap nardi, MD, DMD         
Sub-Investigator: rushinek heli, DMD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: casap nardi, MD, DMD Hadassah Medical Organization

Publications:
Responsible Party: dr. casap nardi, hadassah medical organization, jerusalem, israel
ClinicalTrials.gov Identifier: NCT01085149     History of Changes
Other Study ID Numbers: h123-HMO-CTIL
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: March 11, 2010
Last Verified: March 2010

Keywords provided by Hadassah Medical Organization:
simvastatin
alveolar bone
tooth extraction
remodeling
alveolar bone remodeling

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors