NCT01720797

Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	Micro-osteoperforation	Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.
DRUG	Anesthestic	Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.
OTHER	Chlorhexidine	Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-11-02
• Last updated: 2015-06-19
• Results posted: 2015-06-19

Locations

1 site across 1 country: United States