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NCT03582605 · ClinicalTrials.gov registry record · Early Phase 1

Antibiotics Prior to Mini-screw Implant Insertion

A Early Phase 1 study, sponsored by St. Louis University.

Completed
Registry status
Early Phase 1
Development phase
31
Enrollment target

NCT03582605 is a Early Phase 1 study that has completed, run by St. Louis University. The registered enrollment target is 31 participants.

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The verdict

NCT03582605, a Early Phase 1 study, has completed, sponsored by St. Louis University.

COMPLETED
Registry status
Early Phase 1
Development phase
31 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Placebo oral capsule
  • DRUG Amoxicillin

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2018-08-07
Est. Completion 2020-11-01
Phase Early Phase 1

Sponsor

St. Louis University

107 total trials

What the Registry Record Tells You About NCT03582605

The ClinicalTrials.gov registry entry for NCT03582605 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.

NCT03582605 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03582605 about?

NCT03582605 is a clinical study titled "Antibiotics Prior to Mini-screw Implant Insertion". 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 diam...

What is the current status of trial NCT03582605?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 31 participants. The study started on 2018-08-07. Estimated completion is 2020-11-01.

What interventions are being tested in trial NCT03582605?

The interventions under investigation include: Placebo oral capsule (DRUG), Amoxicillin (DRUG).

Who is sponsoring clinical trial NCT03582605?

This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.