Simvastatin Around Immediate Implant

NCT ID: NCT04803500

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-02

Study Completion Date

2016-05-03

Brief Summary

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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

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Conditions

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Immediate Implant Placement Bone Regeneration Alveolar Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Split-mouth design
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Simvastatin group

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

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Simvastatin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mina Adel Rizk Botros

Assistant Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PER 15-1M

Identifier Type: -

Identifier Source: org_study_id

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