Simvastatin Around Immediate Implant

Phase 2

Completed

• Conditions: Alveolar Bone Resorption; Immediate Implant Placement; Bone Regeneration
• Interventions: Drug: Placebo; Drug: Simvastatin

• Registration Number: NCT04803500
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-02
• Primary Completion: 2016-02-15
• Study Completion: 2016-05-03
• Study First Submitted: 2021-02-07
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-16
• Last Update Submitted: 2021-03-16
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	the solid lipid nanoparticles carrier was injected into the jumping distance.
Simvastatin group	Simvastatin	simvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance.

Primary Outcome Measures

Name	Time	Method
Effect of simvastatin on gap fill	3 months after implant placement	using cone beam computed tomography
Effect of simvastatin on horizontal ridge dimension	3 months after implant placement	using cone beam computed tomography
Effect of simvastatin on crestal bone level	3 months after implant placement	using cone beam computed tomography
Effect of simvastatin on bone density	3 months after implant placement	using cone beam computed tomography

Secondary Outcome Measures

Name	Time	Method
Quality of wound healing	2 weeks after implant placement	wound healing index