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

March 10, 2010
March 10, 2010
May 2010
October 2010   (final data collection date for primary outcome measure)
bone height and density in former socket [ Time Frame: 3 months ] [ Designated as safety issue: No ]
measured on CT
Same as current
No Changes Posted
bone mineralization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
histology from bone in former socket
Same as current
Not Provided
Not Provided
 
The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth
Not Provided

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Hypercholesterolemia
Drug: Simvastatin
10 mg simvastatin, slow release in socket of extracted tooth (single application only)
  • Experimental: study group
    simvastatin will be inserted to sockets
    Intervention: Drug: Simvastatin
  • No Intervention: control
    sockets will be left to healing without material in socket
    Intervention: Drug: Simvastatin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Not Provided
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
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
Israel
 
NCT01085149
h123-HMO-CTIL
Yes
dr. casap nardi, hadassah medical organization, jerusalem, israel
Hadassah Medical Organization
Not Provided
Principal Investigator: casap nardi, MD, DMD Hadassah Medical Organization
Hadassah Medical Organization
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP