N/A
Completed N=21
Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment
Malocclusion
Source: ClinicalTrials.gov NCT01720797 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Tooth Movement Between the Groups — 4.345; 4.04 percentage of movement
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tooth Movement Between the Groups |
4.345; 4.04 | — |
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. Informational only — not medical advice.