Bone LossPhase 2NCT03981601
Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Lovastatin in the Preservation of the Tooth Socket
A Phase 2 study testing Lovastatin 40 MG and without drug with Bone graft in people with Bone Loss, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial summary
Twenty patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which have more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Lovastatin 40 MG and without drug with Bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 22 Feb 2018to 30 Jul 2019
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 18 years old
- tooth fracture, root caries
- Patients are volunteered for placement of the implant
Who cannot join
- systemic diseases
- Pregnancy and breastfeeding
- malignancy, radiation therapy,
- history of periodontal surgery during the six months ago.
- medicine(phosphonates, antibiotic,...)
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Amirhossein Farahmand
Tehran, 19
Amirhossein Farahmand, Assistant Prof, +98 912 4040 359, perio-implant@hotmail.com
About this study
Official title: the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) With Lovastatin in the Preservation of the Tooth Socket
Twenty patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which have more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or Fractures were selected.
Read the detailed description
twenty healthy patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which has more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or Fractures were selected. moreover, divided the socket randomly to two groups(A, B)including A: bone graft with lovastatin and B: bone graft alone, after 3 months with trephine will collect the samples. following the histomorphometric analysis.
- Conditions
- Bone Loss
- Being tested
- Lovastatin 40 MG, without drug with Bone graft
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovastatin 40 MGDrug
Also called Group A
after tooth extraction, put teh lovastatin40 mg wif bone graft wifin tooth socket
without drug with Bone graftProcedure or surgery
Also called Group B
after tooth extraction, put teh bone graft wifin tooth socket
| Study group | Role | What they receive |
|---|---|---|
| lovastatin 40 mg with bone graft | Active comparator | after tooth extraction, put teh lovastatin40 mg wif bone graft wifin tooth socket Receives: Drug: Lovastatin 40 MG |
| without drug with bone graft | Active comparator | after tooth extraction, put the bone graft wifin tooth socket Receives: Procedure: without drug with Bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socket preservation with Lovastatin as evaluated by the amount of bone formation volume
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start22 Feb 2018
- Primary completion30 Mar 2019
- Study completion30 Jul 2019 (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 Bone LossStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amirhossein Farahmand, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981601
- Sponsor's protocol ID
- 2038
- Status last verified
- Jun 2019
- First submitted
- 9 Feb 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farahmand A, Houshmand B, Shirazi AR, Attar Zadeh Y, Taghavi Namin S, Zohary M, Sadeghi MR. Socket preservation with and without lovastatin in combination with synthetic bone graft substitute: A double-blind clinical trial. J Adv Periodontol Implant Dent. 2026 Feb 2;18(2):80-89. doi: 10.34172/japid.026.3919. eCollection 2026 Apr.
PubMed 42254059
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) With Lovastatin in the Preservation of the Tooth Socket
- ClinicalTrials.gov ID
- NCT03981601
- Acronym / sponsor ID
- 2038
- Conditions
- Bone Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 11 Jun 2019 (actual)
- 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.
Twenty patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which have more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or Fractures were selected.
Detailed description
twenty healthy patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which has more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or Fractures were selected. moreover, divided the socket randomly to two groups(A, B)including A: bone graft with lovastatin and B: bone graft alone, after 3 months with trephine will collect the samples. following the histomorphometric analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lovastatin 40 mg with bone graft | Active comparator | Drug: Lovastatin 40 MGafter tooth extraction, put teh lovastatin40 mg wif bone graft wifin tooth socket |
| without drug with bone graft | Active comparator | Procedure: without drug with Bone graftafter tooth extraction, put the bone graft wifin tooth socket |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- at least 18 years old
- tooth fracture, root caries
- Patients are volunteered for placement of the implant
Key exclusion criteria (5 listed)
- systemic diseases
- Pregnancy and breastfeeding
- malignancy, radiation therapy,
- history of periodontal surgery during the six months ago.
- medicine(phosphonates, antibiotic,...)
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 |
|---|---|---|
| Lovastatin 40 MGAlso: Group Aafter tooth extraction, put teh lovastatin40 mg wif bone graft wifin tooth socket | Drug | lovastatin 40 mg with bone graft |
| without drug with Bone graftAlso: Group Bafter tooth extraction, put teh bone graft wifin tooth socket | Procedure or surgery | without drug with bone graft |
Primary outcome
Socket preservation with Lovastatin as evaluated by the amount of bone formation volume
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Derived from this study: PubMed 42254059Farahmand A, Houshmand B, Shirazi AR, Attar Zadeh Y, Taghavi Namin S, Zohary M, Sadeghi MR. Socket preservation with and without lovastatin in combination with synthetic bone graft substitute: A double-blind clinical trial. J Adv Periodontol Implant Dent. 2026 Feb 2;18(2):80-89. doi: 10.34172/japid.026.3919. eCollection 2026 Apr.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lovastatin 40 MG and without drug with Bone graft in people with Bone Loss, run by Islamic Azad University, Sanandaj at 1 site in Iran.
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 3 inclusion and 5 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 Jun 2019. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Amirhossein Farahmand, Assistant Prof (+98 912 404 0359, perio-implant@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socket preservation with Lovastatin as evaluated by the amount of bone formation volume (time frame: 3 month). 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 NCT03981601, 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 Jun 2019.