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Completed

NCT Number: NCT04803500

Simvastatin Around Immediate Implant

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.

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Key information

Conditions

Immediate Implant Placement Alveolar Bone Resorption Bone Regeneration

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

single injection of simvastatin gel in the gap around immediately placed implant

Placebo

Drug

single injection of the solid lipid nanoparticle carrier in the gap around immediately placed implant

Primary outcomes

  1. Effect of simvastatin on gap fill

    Time frame: 3 months after implant placement

    using cone beam computed tomography

  2. Effect of simvastatin on horizontal ridge dimension

    Time frame: 3 months after implant placement

    using cone beam computed tomography

  3. Effect of simvastatin on crestal bone level

    Time frame: 3 months after implant placement

    using cone beam computed tomography

  4. Effect of simvastatin on bone density

    Time frame: 3 months after implant placement

    using cone beam computed tomography

Secondary outcomes

  1. Quality of wound healing

    Time frame: 1 week after implant placement

    wound healing index

  2. Quality of wound healing

    Time frame: 2 weeks after implant placement

    wound healing index

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2021
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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