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NCT04803500 Clinical Trial

Simvastatin Around Immediate Implant

Alveolar Bone Resorption Clinical Trial

Official title:
Restoration of Immediate Peri-implant Defect by Simvastatin: a Controlled Clinical and Cone Beam Computed Tomography Study

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

Related Conditions & MeSH terms

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
See also
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Completed NCT05311332 - Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Augmentation N/A
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Enrolling by invitation NCT04434703 - Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF) N/A
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Not yet recruiting NCT06424223 - Tunnel Access for Horizontal Alveolar Ridge Augmentation N/A
Not yet recruiting NCT04022538 - Evaluation of Vertical Height in Anterior Maxillary Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement N/A
Completed NCT06317090 - Vertical GBR LPRF Block vs. Autogenous Bone With DBBM N/A
Suspended NCT05492838 - Socket Shield Technique With or Without Flap Elevation N/A