Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment (Propel)
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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 |
- 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.
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | November 2014 (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:
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 |
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| 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 |
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 11, 2013 |
| 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 May 19, 2013