Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment

Completed · Not applicable

Conditions studied: Malocclusion

In brief

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.

Key facts

Study ID

NCT01720797

Run by

University of Florida

People needed

21

Starts

2013-02-01

Expected to finish

2015-04-01

Last updated by the study team

2015-06-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)<5mm,Gingival Index (GI)<1,Plaque Index(PI)=1
• If any caries is present, patient will be referred to dentist for treatment and maintenance before beginning treatment
• Able to understand English, follow simple instructions and sign informed consent

You may not qualify if…

• Subjects who have taken any local or systemic antibiotics, corticosteroids or periodontal medications in the previous six weeks.
• Subjects with extreme skeletal class II malocclusion: Overjet>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

Where it is running

• University of Florida, Department of Orthodontics — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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