Malocclusion Clinical Trial
Official title:
Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment
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.
Following informed consent and satisfying the screening/enrollment assessments, a panoramic
and periapical radiograph of the teeth designated for micro-osteoperforation treatment is to
be taken. Prior to the intervention the subjects will swish 5cc of chlorhexidine for one
minute, twice. Micro-osteoperforation, PROPEL™, is conducted under local or topical
anesthesia AFTER the subject is banded and bonded. The procedure will be randomized to
either the left or right side in each subject. Following the procedure, Chlorhexidine rinses
are to begin twice a day for a week.
The subjects will be advised to take Tylenol only in case of significant pain. Subjects will
be seen four to six weeks after completion of treatment for the first follow-up. Subjects
will be followed up with a telephone consult 24 hours after micro-osteoperforation is
performed. They will be asked if any pain medication was taken after being dismissed from
the research center and if so, they will be asked the name and dose of medication taken.
Study will conclude at the 6 month follow up visit or when space on the treating side is
closed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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