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Simvastatin 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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 7, 2021
    Last Updated
    March 16, 2021
    Sponsor
    Ain Shams University
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    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

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