Clinical trial NCT04628390: Laser Therapy on Controlling Pain During Orthondontic Treatment
Official title: Low Level 810nm Laser Therapy on Controlling Pain During a First Stage of Orthondontic Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion
Keywords: Laser
orthodontic
TIP EDGE
Lead sponsor: Fundación Universitaria CIEO
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure the "Change in Orthodontic Pain Levels"
timeFrame: 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)
Secondary outcomes:
measure: Need for analgesic
timeFrame: 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)
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación universitaria CIEO - UniCIEO
Study officials:
affiliation: Fundación universitaria CIEO-UniCIEO
name: Jaime E. Donado, DDS
role: PRINCIPAL_INVESTIGATOR
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