Malocclusion
Conditions
Keywords
Laser, orthodontic, TIP EDGE
Brief summary
To evaluate the effectiveness of pain reduction on a initial orthodontic treatment by using 810nm Diode laser compared to a placebo. Methods: This study will include two parallels groups, 30 adult patients each (mean age 18 - 40) that will be asked to fill a questionnaire related with pain before starting orthodontic treatment with Tip edge technique. Patients from one of the groups will receive laser therapy on both upper and lower maxillary according to the protocol. The patients from the other group will receive a placebo simulating a laser therapy on both maxillary. After the process, both groups will be checked on different times (12hrs-24hrs-48hrs-72hrs after) by filling a questionnaire related with pain each time.
Detailed description
This is a parallel, double-blind, controlled, single-center clinical trial conducted in systemically healthy subjects requiring orthodontic treatment without extractions at the start of treatment in Bogotá, Colombia. Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial. This study will consist of a single visit by the patient, in this visit the assembly and activation of the upper and lower orthodontic appliances will be carried out. Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours). After Screening a computer-generated scrambling code will be used for allocation in blocks of 6 to the two treatments. The identity of included patients will not be provided to the trial team, in order to preserve the blinded aspect of the trial. The identity of the research treatment associated with each randomization number will be hidden from the trial team and patients. The final analysis is scheduled for when 100% of the patients (60 subjects) reach the 72-hour evaluation.
Interventions
DEVICELaser
The laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
OTHERPlacebo
Simulation laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
Sponsors
Fundación Universitaria CIEO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patients participating in the clinical trial, the statistician in charge of the data analysis and the orthodontist will be blinded to the interventions carried out. The investigator in charge of applying the intervention will not be blinded.
Intervention model description
Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial. Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must have signed and dated an informed consent form approved by the IRB in accordance with regulatory and institutional guidelines. This form must be obtained before performing any procedure related to the protocol that is not part of the subject's normal regimen. * No need extractions * No need Stripping
Exclusion criteria
* Periodontal disease * Pregnant or lactance * Medicated patients (analgesic, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers) * Cardiac markpaser
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the Change in Orthodontic Pain Levels | Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment) | The evaluation of the difference in pain levels will be determined as a percentage of change and difference in means of pain levels. The difference and the percentage will be calculated by comparing the baseline pain levels observed between the different follow-up times. A rule of three is applied to determine the percentage of change (%) and a subtraction of the pain averages to calculate the difference. Pain analysis will be performed using the visual analog scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for analgesic | Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment) | Frequency and Need after the treatment |
Countries
Colombia
Contacts
Primary ContactJaime E. Donado, DDS
Backup ContactJulio C. Castro, DDS
Outcome results
None listed