Simvastatin Around Immediate Implant

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04803500

Enrollment

Registered

2021-03-17

Start date

2015-04-02

Completion date

2016-05-03

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Resorption, Bone Regeneration, Immediate Implant Placement

Keywords

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

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.

Interventions

DRUGSimvastatin

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Split-mouth design

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Quality of wound healing	1 week after implant placement	wound healing index

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026