Restoration of Immediate Peri-implant Defect by Simvastatin: a Controlled Clinical and Cone Beam Computed Tomography Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 10
- Primary Endpoint
- Effect of simvastatin on gap fill
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control group
the solid lipid nanoparticles carrier was injected into the jumping distance.
Intervention: Placebo (Drug)
Simvastatin group
simvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance.
Intervention: Simvastatin (Drug)
Outcomes
Primary Outcomes
Effect of simvastatin on gap fill
Time Frame: 3 months after implant placement
using cone beam computed tomography
Effect of simvastatin on horizontal ridge dimension
Time Frame: 3 months after implant placement
using cone beam computed tomography
Effect of simvastatin on crestal bone level
Time Frame: 3 months after implant placement
using cone beam computed tomography
Effect of simvastatin on bone density
Time Frame: 3 months after implant placement
using cone beam computed tomography
Secondary Outcomes
- Quality of wound healing(2 weeks after implant placement)
Investigators
Mina Adel Rizk Botros
Assistant Researcher
Ain Shams University