Simvastatin Around Immediate Implant

NCT04803500 | Completed Phase 2

• 1 other identifier: PER 15-1M
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immediate Implant Placement; Bone Regeneration; Alveolar Bone Resorption

Keywords

Simvastatin; Immediate implant placement; gap distance; ridge dimension alteration; cone beam computed tomopgraphy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Quality of wound healing

  1 week after implant placement

• Quality of wound healing

  2 weeks after implant placement

Study Arms (2)

Simvastatin group

ACTIVE COMPARATOR

simvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance.

Drug: Simvastatin

Control group

PLACEBO COMPARATOR

the solid lipid nanoparticles carrier was injected into the jumping distance.

Drug: Placebo

Interventions

Simvastatin DRUG

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

Simvastatin group

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Simvastatin

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Researcher

Model Details: Split-mouth design

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: March 17, 2021
• Study Start: April 2, 2015
• Primary Completion: February 15, 2016
• Study Completion: May 3, 2016
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share