CClinicalTrials.gg
Status unknownNCT01085149Updated Mar 11, 2010

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

An interventional study of Simvastatin in Hypercholesterolemia, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-11.

Sponsored by Hadassah Medical Organization · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Mar 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • simvastatin
  • alveolar bone
  • tooth extraction
  • remodeling
  • alveolar bone remodeling
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's planned enrollment of 20 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • treated with simvastatin P.O for hypercholesterolemia
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    study group

    simvastatin will be inserted to sockets

    Drug: Simvastatin

  • No intervention
    control

    sockets will be left to healing without material in socket

    Drug: Simvastatin

Interventions

  • DrugSimvastatin

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

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What researchers measure

Primary outcomes

  1. bone height and density in former socket

    measured on CT

    Time frame: 3 months

Secondary outcomes

  1. bone mineralization

    histology from bone in former socket

    Time frame: 3 months

07

Study locations

1 site
  • Oral and Maxillofacial Clinic, Hadassah
    Jerusalem, 91120, Israel
    • casap nardi, MD, DMD · Contact · nard@md.huji.ac.il · 00 972 2 6776148
    • rushinek heli, DMD · Contact · heliru@walla.com · 00 972 26776148
    • casap nardi, MD, DMD · Principal investigator
    • rushinek heli, DMD · Sub investigator
08

References and documents

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. PubMed 17804200 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01085149
Lead sponsor
Hadassah Medical Organization
First posted
Mar 11, 2010
Start date
May 2010
Primary completion
Oct 2010 (estimated)
Last update
Mar 11, 2010

Study contacts

casap nardi, MD, DMD
Contact
nard@md.huji.ac.il
00 972 2 6776148 ext. 2
rushinek heli, DMD
Contact
heliru@walla.com
00 972 2 6776148 ext. 2
casap nardi, MD, DMD
principal investigator · Hadassah Medical Organization

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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