Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: AlevoLogic LLC
• Treatments: Anesthetics; Anesthetics, Local; Chlorhexidine; Chlorhexidine gluconate

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)<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

Exclusion Criteria:

• 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