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

This study has been completed.
Sponsor:
Collaborator:
AlevoLogic LLC
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01720797
First received: October 31, 2012
Last updated: June 2, 2015
Last verified: June 2015
Results First Received: June 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malocclusion
Interventions: Device: Micro-osteoperforation
Drug: Anesthestic
Other: Chlorhexidine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.

Micro-osteoperforation: Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.

Anesthestic: Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.

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.

Non Micro-osteoperforation 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.

Participant Flow:   Overall Study
    Micro-osteoperforation     Non Micro-osteoperforation  
STARTED     12     9  
COMPLETED     9     9  
NOT COMPLETED     3     0  
Withdrawal by Subject                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
Non Micro-osteoperforation 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.
Total Total of all reporting groups

Baseline Measures
    Micro-osteoperforation     Non Micro-osteoperforation     Total  
Number of Participants  
[units: participants]
  12     9     21  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     9     21  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     7     7     14  
Male     5     2     7  
Region of Enrollment  
[units: participants]
     
United States     12     9     21  



  Outcome Measures

1.  Primary:   Tooth Movement Between the Groups   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Calogero Dolce, DDS, PhD
Organization: University of Florida
phone: 352-273-5700
e-mail: cdolce@dental.ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01720797     History of Changes
Other Study ID Numbers: 20121593
Study First Received: October 31, 2012
Results First Received: June 2, 2015
Last Updated: June 2, 2015
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board