Laser Therapy on Controlling Pain During Orthondontic Treatment

Not Applicable

• Conditions: Malocclusion
• Interventions: Device: Laser; Other: Placebo

• Registration Number: NCT04628390
• Lead Sponsor: Fundación Universitaria CIEO

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-07
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-13
• Study Start: 2020-11-20
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-24
• Primary Completion: 2021-01-20
• Study Completion: 2021-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Laser	The low-power therapeutic diode laser will be applied with a wavelength 810nm ± 15nm, output power 0-2 W CW / 0-4.8 W peak power (pulse mode), for a time of 20 seconds per centimeter at lo along the buccal surface of the root of the upper and lower teeth.
Placebo	Placebo	A simulation of the application of therapeutic laser will be carried out as a placebo effect, for a time of 20 seconds per centimeter along the vestibular surface of the root of the upper and lower teeth.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fundación universitaria CIEO - UniCIEO; 🇨🇴 Bogotá, Colombia