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Effect of a Double Dose of Photobiomodulaton Therapy on Orthodonthic Pain Caused by Elastomeric Separators

NCT04532476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-08-31

No results posted yet for this study

Summary

It has been reported that 90% of the patients experience pain during orthodontic treat-ment. The purpose of this study was to compare the effect of a double dose of photobio-modulation (PBM) therapy on pain perception in patients having fixed appliance treat-ment.

Twenty-two patients were recruited to participate in this single-blinded, place-bo-controlled study. Four elastomeric separators were placed, mesially and distally to the upper first molar on each side. The right side of the upper jaw was treated with low-power diode laser, and the left side was a placebo, same treatment with laser switched off. Two doses of PBM therapy (660nm, 90mW) were delivered 24 hours apart. The par-ticipants filled out the questionnaire immediately after the placement of separators and before 1st laser treatment (TO), 12 hours (T1), 24 hours (T2), 2 days (T3) and 3 days after the 1st treatment (T4). At each evaluation period, the degree of pain was scored twice, one for each side.

Conditions

  • Pain Relief Caused by Placing Orthodontic Separators

Interventions

DEVICE

Low level laser therapy

Diode laser (Laser HF, Hager-Werken GmbH \& Co., Duisburg, Germany) was applied to the RIGHT side. Laser was set at PDT mode (660nm) acupuncture therapy. The power of the laser was set at 90 mW in intervals of 80 seconds as recommended by the manufacturer. The laser was applied perpendicular in contact with the mucosa on 1 point of the buccal and 1 point on the palatal side of the first molar approximately on the middle part of the root, with the 10mm distance from the laser to the mucosa. Each point was treated in 3 intervals, 80s each, in total 240s on vestibular and 240s on the palatal side per tooth. The treated surface was 1cm2. The power of the laser was 90mW, wavelength 660n, beam area 1 cm2, irradiance per target 0.09 W/cm2, during 240 seconds of treatment interval per point- 21.6J/cm2 of energy was delivered. The same laser treatment was performed the next day, as the pain was noted to be highest within 24 hours after the placement of separators.

Sponsors & Collaborators

  • University of Zagreb

    collaborator OTHER

  • University Hospital Rijeka

    lead OTHER

Principal Investigators

  • Senka Mestrovic, DDS, PhD · University of Zagreb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-20
Primary Completion
2020-06-20
Completion
2020-07-01

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532476 on ClinicalTrials.gov