Malocclusion
Conditions
Keywords
Malocclusion, Accelerated tooth movement, Braces, Orthodontic treatment, Propel
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.
Interventions
DEVICEMicro-osteoperforation
Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.
DRUGAnesthestic
Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.
OTHERChlorhexidine
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.
Sponsors
AlevoLogic LLC
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tooth Movement Between the Groups | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 9 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Micro-osteoperforation | Non Micro-osteoperforation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 9 Participants | 21 Participants |
| Region of Enrollment United States | 12 participants | 9 participants | 21 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micro-osteoperforation | Tooth Movement Between the Groups | 4.345 percentage of movement | Standard Deviation 1.257 |
| Non Micro-osteoperforation | Tooth Movement Between the Groups | 4.04 percentage of movement | Standard Deviation 0.991 |