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

NCT ID: NCT01085149

Last Updated: 2010-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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study group

simvastatin will be inserted to sockets

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

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

control

sockets will be left to healing without material in socket

Group Type NO_INTERVENTION

Simvastatin

Intervention Type DRUG

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

Interventions

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Simvastatin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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hadassah medical organization, jerusalem, israel

Principal Investigators

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casap nardi, MD, DMD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Oral and Maxillofacial Clinic, Hadassah

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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casap nardi, MD, DMD

Role: CONTACT

00 972 2 6776148 ext. 2

rushinek heli, DMD

Role: CONTACT

00 972 2 6776148 ext. 2

Facility Contacts

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casap nardi, MD, DMD

Role: primary

00 972 2 6776148 ext. 2

rushinek heli, DMD

Role: backup

00 972 26776148 ext. 2

References

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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.

Reference Type BACKGROUND
PMID: 17804200 (View on PubMed)

Other Identifiers

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h123-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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