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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01085149
First received: March 10, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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
Hypercholesterolemia
Drug: Simvastatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    measured on CT


Secondary Outcome Measures:
  • bone mineralization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: March 10, 2010
Last Updated: March 10, 2010
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 25, 2014