Antibiotics Prior to Mini-screw Implant Insertion

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Inflammation at Mini-screw Insertion Site, Mobility, Mini-screw

In brief

The investigators plan to use amoxicillin in capsule form, prepared by a pharmacist, for antibiotic prophylaxis to decrease the failure rate of mini-screw implants temporarily placed in the palate of patients involved in Phase II orthodontics treatments. The mini-screws will be 8 mm long 1.7 mm diameter titanium screws manufactured by Forestadent and are commercially available and currently widely used in orthodontic treatment in both private practice and educational settings. Since antibiotic prophylaxis is considered the standard of care with traditional dental implants, the investigators believe that such prophylaxis will decrease the failure rate of orthodontic mini-screw implants also.

Key facts

Study ID

NCT03582605

Run by

St. Louis University

People needed

31

Starts

2018-08-07

Expected to finish

2020-11-01

Last updated by the study team

2020-11-12

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with experience in previous MSI placements
• allergy to amoxicillin
• allergy to Beta-lactam based antibiotics
• medical syndrome diagnoses
• psychiatric disorders (ADHD, autism, manic-depressive disorder, etc.)
• a compromised immune system
• impaired or decreased kidney function
• Type I or Type II diabetes
• patients taking Probenicid or Allopurinol

Where it is running

• Saint Louis University Center for Advanced Dental Education — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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