Clinical trial NCT01720797: Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment
Official title: Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Malocclusion
Accelerated tooth movement
Braces
Orthodontic treatment
Propel
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: AlevoLogic LLC
First posted: 2012-11-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tooth Movement Between the Groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida, Department of Orthodontics
state: Florida
Study officials:
affiliation: University of Florida, Interim Chair
name: Calogero Dolce, D.D.S, PhD
role: PRINCIPAL_INVESTIGATOR
References: