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

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

Study Overview

• Status: Unknown
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Simvastatin

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
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Oral and Maxillofacial Clinic, Hadassah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone height and density in former socket	measured on CT	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone mineralization	histology from bone in former socket	3 months

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: casap nardi, MD, DMD, Hadassah Medical Organization

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.ijom.2007.06.018. Epub 2007 Sep 4.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): October 1, 2010

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 10, 2010
• First Posted (Estimate): March 11, 2010

Study Record Updates

• Last Update Posted (Estimate): March 11, 2010
• Last Update Submitted That Met QC Criteria: March 10, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: simvastatin; remodeling; alveolar bone; tooth extraction; alveolar bone remodeling
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: h123-HMO-CTIL