CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 31 enrolled
Drug / intervention
Amoxicillin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03582605
NCT03582605Early Ph 1Completed

Antibiotic Prophylaxis Prior to the Insertion of Orthodontic Mini-screw Implants: a Randomized Controlled Trial

St. Louis University·interventional·Posted Jul 11, 2018·Updated Nov 12, 2020

In Brief

A Early Phase 1 clinical trial evaluating Amoxicillin and Placebo oral capsule for Inflammation at Mini-screw Insertion Site and Mobility, Mini-screw. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedJul 11, 2018
Enrollment StartAug 7, 2018
Primary CompletionOct 1, 2020
Study CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.0 years ago

Interventions

Amoxicillindrug

see previous descriptions

Placebo oral capsuledrug

see previous descriptions