HypercholesterolemiaNCT01085149
The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth
A study testing Simvastatin in people with Hypercholesterolemia, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- need extraction of single root tooth
- intend to have prosthetic implant in place of extraction
Who cannot join
- treated with simvastatin P.O for hypercholesterolemia
Trial locations and contacts
1 site in 1 country.
Israel1 site
Oral and Maxillofacial Clinic, Hadassah
Jerusalem, 91120
casap nardi, MD, DMD, 00 972 2 6776148 ext. 2, nard@md.huji.ac.il
rushinek heli, DMD, 00 972 26776148 ext. 2, heliru@walla.com
About this study
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.
- Conditions
- Hypercholesterolemia
- Being tested
- Simvastatin
- Keywords
- simvastatin, alveolar bone, tooth extraction, remodeling, alveolar bone remodeling
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
10 mg simvastatin, slow release in socket of extracted tooth (single application only)
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | simvastatin will be inserted to sockets Receives: Drug: Simvastatin |
| control | No intervention | sockets will be left to healing without material in socket Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height and density in former socket
measured on CT
Measured: 3 months
Secondary outcomes (1)
bone mineralization
histology from bone in former socket
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- casap nardi, MD, DMD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085149
- Sponsor's protocol ID
- h123-HMO-CTIL
- Status last verified
- Mar 2010
- First submitted
- 10 Mar 2010
- Last updated
- 11 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth
- ClinicalTrials.gov ID
- NCT01085149
- Acronym / sponsor ID
- h123-HMO-CTIL
- Conditions
- Hypercholesterolemia
- Keywords
- simvastatin, alveolar bone, tooth extraction, remodeling, alveolar bone remodeling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2010 (estimated)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Simvastatinsimvastatin will be inserted to sockets |
| control | No intervention | Drug: Simvastatinsockets will be left to healing without material in socket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- need extraction of single root tooth
- intend to have prosthetic implant in place of extraction
Key exclusion criteria (1 listed)
- treated with simvastatin P.O for hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin10 mg simvastatin, slow release in socket of extracted tooth (single application only) | Drug | control, study group |
Primary outcome
bone height and density in former socket
Time frame: 3 months
measured on CT
1 secondary outcome
bone mineralization
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2010.
- Background: PubMed 17804200Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
casap nardi, MD, DMD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simvastatin in people with Hypercholesterolemia, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact casap nardi, MD, DMD (00 972 2 6776148 ext. 2, nard@md.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone height and density in former socket (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01085149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2010; AzTrials last refreshed its copy on 6 Nov 2026.