N/A
N=21
Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment
Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT01720797 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Tooth Movement Between the Groups — 4.345; 4.04 percentage of movement
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Micro-osteoperforation (Device); Anesthestic (Drug); Chlorhexidine (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tooth Movement Between the Groups |
4.345; 4.04 | — |
Summary
The purpose of this research study is to assess the clinical effectiveness of the procedure of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth movement in patients undergoing orthodontic treatment. "Accelerated tooth movement" means that using the PROPEL™ device may help complete your treatment with braces on one side of your mouth sooner than would be expected if the device were not to be used.
Eligibility Criteria
Inclusion Criteria
- Adolescent and adult subjects ages 18-55 years old, in good general health, with adult or mixed dentition, regardless of presence of third molars.
- Subjects are American Society of Anesthesiologists (ASA) class I (ASA class I - Patients are considered to be normal and healthy).
- Periodontal or gingivitis diseases must be addressed prior to study enrollments: Probing Depth(PD) 10mm, (Pogonion to Nasion Perpendicular line)Pg-Nper>18mm, A point Nasion B point (ANB)>7, Sella Nasion line to Gonion Gnathion Line (SN-GoGN)>38
- Vulnerable subjects who unable to consent for themselves
Data sourced from ClinicalTrials.gov (NCT01720797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.