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

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01085149
• Other study ID #: h123-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 10, 2010
• Last updated: March 10, 2010
• Start date: May 2010

Study information

• Verified date: March 2010
• Source: Hadassah Medical Organization
• Contact: casap nardi, MD, DMD
• Phone: 00 972 2 6776148
• Email: nard[@]md.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Simvastatin
10 mg simvastatin, slow release in socket of extracted tooth (single application only)

Locations

Country	Name	City	State
Israel	Oral and Maxillofacial Clinic, Hadassah	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone height and density in former socket	measured on CT	3 months	No
Secondary	bone mineralization	histology from bone in former socket	3 months	No