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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
AlevoLogic LLC
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01720797
First received: October 31, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Malocclusion
Device: Micro-osteoperforation
Drug: Anesthestic
Other: Chlorhexidine

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 15
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)
Arms Assigned Interventions
Micro-osteoperforation
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.
Device: Micro-osteoperforation
Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.
Other Names:
  • Micro-osteoperforation
  • PROPEL
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720797

Locations
United States, Florida
University of Florida, Department of Orthodontics
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
AlevoLogic LLC
Investigators
Principal Investigator: Calogero Dolce, D.D.S, PhD University of Florida, Interim Chair
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01720797     History of Changes
Other Study ID Numbers: 20121593
Study First Received: October 31, 2012
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

Keywords provided by University of Florida:
Malocclusion
Accelerated tooth movement
Braces
Orthodontic treatment
Propel

Additional relevant MeSH terms:
Inflammation
Malocclusion
Pathologic Processes
Tooth Diseases
Stomatognathic Diseases
Anesthetics, Local
Chlorhexidine
Chlorhexidine gluconate
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 22, 2014