Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment (Propel)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment|
- Tooth Movement [ Time Frame: 6 months ] [ Designated as safety issue: No ]Subject success, supported by procedure completion and accelerated tooth movement effectiveness as measured by dental impressions. These impressions at follow-up will evaluate the rate of tooth movement by measuring casts, in mm.
- Radiographic [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Radiographic documentation of changes during the first 6 months of orthodontic treatment. Evaluation of the images will elucidate bone status, estimate the extent of perforation, and show any root damage, root angulation and any tooth movement.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. 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.
Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.
Other Names: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.
Other Name: Peridex
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720797
|United States, Florida|
|University of Florida, Department of Orthodontics|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Calogero Dolce, D.D.S, PhD||University of Florida, Interim Chair|