Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment

Malocclusion Clinical Trial

— Propel  

Official title:

Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720797
• Other study ID #: 20121593
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: June 2, 2015
• Start date: February 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malocclusion

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida, Department of Orthodontics	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	AlevoLogic LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth Movement Between the Groups	Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts.; Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement.	6 months	No