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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04803500
Other study ID # PER 15-1M
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2, 2015
Est. completion date May 3, 2016

Study information

Verified date March 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study evaluated the effect of local application of simvastatin around immediate implant on the amount of gap fill, ridge dimensional alterations and bone density in humans.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 3, 2016
Est. primary completion date February 15, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Patients between 20 and 50 years old - requiring the extraction of 2 non-restorable maxillary canine or premolar on each side of the arch - following extraction, the crestal bone had to be located 3 mm apical to the free gingival margin - at least 3 mm of bone beyond the root apex was required to guarantee implant primary stability Exclusion Criteria: - unstable systemic diseases precluding surgical procedures - compromised general health conditions that would impair bone healing including present history of bone irradiation, patient on bisphosphonates therapy, antitumor chemotherapy - pregnancy - compromised healing conditions e.g. uncontrolled diabetes mellitus

Study Design


Intervention

Drug:
Simvastatin
single injection of simvastatin gel in the gap around immediately placed implant
Placebo
single injection of the solid lipid nanoparticle carrier in the gap around immediately placed implant

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of simvastatin on gap fill using cone beam computed tomography 3 months after implant placement
Primary Effect of simvastatin on horizontal ridge dimension using cone beam computed tomography 3 months after implant placement
Primary Effect of simvastatin on crestal bone level using cone beam computed tomography 3 months after implant placement
Primary Effect of simvastatin on bone density using cone beam computed tomography 3 months after implant placement
Secondary Quality of wound healing wound healing index 1 week after implant placement
Secondary Quality of wound healing wound healing index 2 weeks after implant placement
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