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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: Completed Early Phase 1 study, sponsored by St. Louis University.
NCT03582605 is a Early Phase 1 study that has completed, run by St. Louis University. The registered enrollment target is 31 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants will undergo an intra-oral exam to determine mobility of the mini-screw(s), to check for inflammation at the site of mini-screw placement. Mobility will be determined by placing a small amount of force on the mini-screw with a cotton plier. The amount of mobility will be assessed as having no mobility (Grade 0), having between 0mm and 1 mm of mobility (Grade 1), or having more than 1 mm of mobility (Grade 2). Inflammation will be assessed as having no redness or swelling at the site
Interventions
- DRUG Placebo oral capsule
- DRUG Amoxicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-08-07 |
| Est. Completion | 2020-11-01 |
| Phase | Early Phase 1 |
What the finished NCT03582605 record still lists
NCT03582605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03582605 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03582605's enrollment target sits among peer trials
31 794th of 2000 higher than 1,195 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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