Back to resultsSimvastatin Around Immediate Implant
Primary Purpose
Immediate Implant Placement, Bone Regeneration, Alveolar Bone Resorption
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Simvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Immediate Implant Placement focused on measuring Simvastatin, Immediate implant placement, gap distance, ridge dimension alteration, cone beam computed tomopgraphy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Simvastatin group
Control group
Arm Description
simvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance.
the solid lipid nanoparticles carrier was injected into the jumping distance.
Outcomes
Primary Outcome Measures
Effect of simvastatin on gap fill
using cone beam computed tomography
Effect of simvastatin on horizontal ridge dimension
using cone beam computed tomography
Effect of simvastatin on crestal bone level
using cone beam computed tomography
Effect of simvastatin on bone density
using cone beam computed tomography
Secondary Outcome Measures
Quality of wound healing
wound healing index
Quality of wound healing
wound healing index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04803500
Brief Title
Simvastatin Around Immediate Implant
Official Title
Restoration of Immediate Peri-implant Defect by Simvastatin: a Controlled Clinical and Cone Beam Computed Tomography Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2015 (Actual)
Primary Completion Date
February 15, 2016 (Actual)
Study Completion Date
May 3, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immediate Implant Placement, Bone Regeneration, Alveolar Bone Resorption
Keywords
Simvastatin, Immediate implant placement, gap distance, ridge dimension alteration, cone beam computed tomopgraphy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Split-mouth design
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simvastatin group
Arm Type
Active Comparator
Arm Description
simvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
the solid lipid nanoparticles carrier was injected into the jumping distance.
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
single injection of simvastatin gel in the gap around immediately placed implant
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single injection of the solid lipid nanoparticle carrier in the gap around immediately placed implant
Primary Outcome Measure Information:
Title
Effect of simvastatin on gap fill
Description
using cone beam computed tomography
Time Frame
3 months after implant placement
Title
Effect of simvastatin on horizontal ridge dimension
Description
using cone beam computed tomography
Time Frame
3 months after implant placement
Title
Effect of simvastatin on crestal bone level
Description
using cone beam computed tomography
Time Frame
3 months after implant placement
Title
Effect of simvastatin on bone density
Description
using cone beam computed tomography
Time Frame
3 months after implant placement
Secondary Outcome Measure Information:
Title
Quality of wound healing
Description
wound healing index
Time Frame
1 week after implant placement
Title
Quality of wound healing
Description
wound healing index
Time Frame
2 weeks after implant placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Simvastatin Around Immediate Implant
We'll reach out to this number within 24 hrs