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Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment (Propel)

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Micro-osteoperforation
Anesthestic
Chlorhexidine
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Malocclusion, Accelerated tooth movement, Braces, Orthodontic treatment, Propel

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida, Department of Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Micro-osteoperforation

Non Micro-osteoperforation

Arm Description

Minimally invasive micro-osteoperforation (PROPEL™) 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, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.

Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2012
Last Updated
June 2, 2015
Sponsor
University of Florida
Collaborators
AlevoLogic LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01720797
Brief Title
Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment
Acronym
Propel
Official Title
Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
AlevoLogic LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Malocclusion, Accelerated tooth movement, Braces, Orthodontic treatment, Propel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micro-osteoperforation
Arm Type
Experimental
Arm Description
Minimally invasive micro-osteoperforation (PROPEL™) 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, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
Arm Title
Non Micro-osteoperforation
Arm Type
Other
Arm Description
Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
Intervention Type
Device
Intervention Name(s)
Micro-osteoperforation
Other Intervention Name(s)
PROPEL™
Intervention Description
Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.
Intervention Type
Drug
Intervention Name(s)
Anesthestic
Other Intervention Name(s)
Topical or local anesthetic
Intervention Description
Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.
Intervention Type
Other
Intervention Name(s)
Chlorhexidine
Other Intervention Name(s)
Peridex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tooth Movement Between the Groups
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Calogero Dolce, D.D.S, PhD
Organizational Affiliation
University of Florida, Interim Chair
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida, Department of Orthodontics
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment

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