Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Lovastatin in the Preservation of the Tooth Socket

June 10, 2019 updated by: Amirhossein Farahmand, Islamic Azad University, Tehran

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. at least 18 years old
  2. tooth fracture, root caries
  3. Patients are volunteered for placement of the implant

Exclusion Criteria:

  1. systemic diseases
  2. Pregnancy and breastfeeding
  3. malignancy, radiation therapy,
  4. history of periodontal surgery during the six months ago.
  5. medicine(phosphonates, antibiotic,...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lovastatin 40 mg with bone graft
after tooth extraction, put teh lovastatin40 mg wif bone graft wifin tooth socket
Drug: Lovastatin 40 MG
after tooth extraction, put teh lovastatin40 mg wif bone graft wifin tooth socket
Other Names:
  • Group A
Active Comparator: without drug with bone graft
after tooth extraction, put the bone graft wifin tooth socket
Procedure: without drug with Bone graft
after tooth extraction, put teh bone graft wifin tooth socket
Other Names:
  • Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Socket preservation with Lovastatin as evaluated by the amount of bone formation volume
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Islamic Azad University, Tehran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2018

Primary Completion (Actual)

March 30, 2019

Study Completion (Anticipated)

July 30, 2019

Study Registration Dates

First Submitted

February 9, 2019

First Submitted That Met QC Criteria

June 10, 2019

First Posted (Actual)

June 11, 2019

Study Record Updates

Last Update Posted (Actual)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 10, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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