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Antibiotics Prior to Mini-screw Implant Insertion

NCT03582605 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-11-12

No results posted yet for this 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.

Conditions

  • Inflammation at Mini-screw Insertion Site
  • Mobility, Mini-screw

Interventions

DRUG

Amoxicillin

see previous descriptions

DRUG

Placebo oral capsule

see previous descriptions

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Hiroshi Ueno, DDS · Full time faculty

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2020-10-01
Completion
2020-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582605 on ClinicalTrials.gov