NCT01085149

Brief 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Last Updated

March 11, 2010

Status Verified

March 1, 2010

Enrollment Period

5 months

First QC Date

March 10, 2010

Last Update Submit

March 10, 2010

Conditions

Hypercholesterolemia

Keywords

simvastatinalveolar bonetooth extractionremodelingalveolar bone remodeling

Outcome Measures

Primary Outcomes (1)

  • bone height and density in former socket

    measured on CT

    3 months

Secondary Outcomes (1)

  • bone mineralization

    3 months

Study Arms (2)

study group

EXPERIMENTAL

simvastatin will be inserted to sockets

Drug: Simvastatin

control

NO INTERVENTION

sockets will be left to healing without material in socket

Drug: Simvastatin

Interventions

SimvastatinDRUG

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

controlstudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • need extraction of single root tooth
  • intend to have prosthetic implant in place of extraction

You may not qualify if:

  • treated with simvastatin P.O for hypercholesterolemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral and Maxillofacial Clinic, Hadassah

Jerusalem, 91120, Israel

Location

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

    PMID: 17804200BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • casap nardi, MD, DMD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

casap nardi, MD, DMD

CONTACT

00 972 2 6776148nard@md.huji.ac.il

rushinek heli, DMD

CONTACT

00 972 2 6776148heliru@walla.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2010

Last Updated

March 11, 2010

Record last verified: 2010-03

Locations

IL(1)