Simvastatin Around Immediate Implant

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Immediate Implant Placement; Alveolar Bone Resorption; Bone Regeneration

Treatments: Drug: Simvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04803500

PER 15-1M

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

Simvastatin group

Active Comparator group

Description:

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

Treatment:

Drug: Simvastatin

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo