Simvastatin Around Immediate Implant

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Immediate Implant Placement, Bone Regeneration, Alveolar Bone Resorption

Intervention / Treatment
-----------------
* Drug: Simvastatin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Split-mouth design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simvastatin group<br>simvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance. | Drug: Simvastatin<br>* single injection of simvastatin gel in the gap around immediately placed implant<br>|
| Placebo Comparator: Control group<br>the solid lipid nanoparticles carrier was injected into the jumping distance. | Drug: Placebo<br>* single injection of the solid lipid nanoparticle carrier in the gap around immediately placed implant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of simvastatin on gap fill | using cone beam computed tomography | 3 months after implant placement | 
| Effect of simvastatin on horizontal ridge dimension | using cone beam computed tomography | 3 months after implant placement | 
| Effect of simvastatin on crestal bone level | using cone beam computed tomography | 3 months after implant placement | 
| Effect of simvastatin on bone density | using cone beam computed tomography | 3 months after implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of wound healing | wound healing index | 1 week after implant placement | 
| Quality of wound healing | wound healing index | 2 weeks after implant placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Simvastatin, Immediate implant placement, gap distance, ridge dimension alteration, cone beam computed tomopgraphy