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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: March 10, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
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 Intervention
Drug: Simvastatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

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

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

Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01085149

Contact: casap nardi, MD, DMD 00 972 2 6776148 ext 2
Contact: rushinek heli, DMD 00 972 2 6776148 ext 2

Oral and Maxillofacial Clinic, Hadassah Not yet recruiting
Jerusalem, Israel, 91120
Contact: casap nardi, MD, DMD    00 972 2 6776148 ext 2   
Contact: rushinek heli, DMD    00 972 26776148 ext 2   
Principal Investigator: casap nardi, MD, DMD         
Sub-Investigator: rushinek heli, DMD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: casap nardi, MD, DMD Hadassah Medical Organization
  More Information

Responsible Party: dr. casap nardi, hadassah medical organization, jerusalem, israel Identifier: NCT01085149     History of Changes
Other Study ID Numbers: h123-HMO-CTIL
Study First Received: March 10, 2010
Last Updated: March 10, 2010

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

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on April 28, 2017