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Active, Not Recruiting

NCT Number: NCT05924204

Effect of Photobiomodulation on Pain Control After Placement of Elastomeric Spacers.

Recent studies have shown that photobiomodulation (FBM) can modulate pain after the placement of elastomeric separators, however, to date, there is no ideal protocol for its application. Therefore, the objective of this study will be to evaluate the effect of photobiomodulation on pain control 24 hours after the placement of elastomeric separators using the visual analog scale (VAS). 25 patients between 13 and 30 years old with the need for the placement of orthodontic bands in the lower first molars bilaterally will be included, which establishes a sample of fifty molars.

Elastomeric separators will be placed on the mesial and distal surfaces of the right and left molars. Treatment will be randomized to the right molar and the opposite treatment will be applied to the left side. The study groups will be G1 (experimental) - elastomeric separators + FBM (diode laser, 808nm, 100mw power, with 2 J, 3 points per vestibular and 3 points per palatal, single session, 707J/cm2) and G2-(control)- elastomeric separators + FBM simulation. The patient and the evaluator will be blinded to the intervention performed. The primary outcome variable will be spontaneous pain assessed 24 hours after the placement of elastomeric separators measured with the VAS scale. Secondary outcome variables will be pain during mastication (measured with the VAS scale), count of the number of analgesics (paracetamol), local temperature (measured with a digital thermometer), and assess the impact of oral health on quality of life. of the participant, the OHIP-14 questionnaire will be applied. These outcomes will be evaluated at baseline, 24 with the presence of the participant, and 72 hours after the placement of elastomeric separators. If the data are normal, they will be submitted to the ANOVA - one-way test. Data will be presented as means ± SD and the p-value will be set to < 0.05.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

13 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anna Carolina R.T. Horliana

São Paulo, 11030-480, Brazil

About this study

This randomized, controlled, double-blind, split-mouth clinical trial meets the criteria for designing a clinical study under the conditions of the SPIRIT Statement. The study was approved by the Committee for Ethics in Research (CEP) of the Universidad Católica del Uruguay. The participants who will be recruited are patients who are undergoing orthodontic treatment at the Orthodontic Clinic of the Specialization Course in Orthopedics and Orthodontics at the Catholic University of Uruguay in the city of Montevideo, Uruguay; those who require the installation of bands on the lower first permanent molars.

Any change or change will be reported and clarified to the CEP and informed in publications. A copy of the signed informed consent will be sent to the participant by email (completed in the TCLE). The project will be registered at www.clinicaltrial.gov There is no conflict of interest about any product used in the work and about any author involved in the studio. The data will be published and there will be no restriction on the inclusion of data for publication. All data will be available for your consultation, and all patients will have access to their medical records at any time they wish.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will include:
  • With the need to place bilateral orthodontic bands on the lower first molars.
  • Age 13 to 30 years old.
  • Both sexes.
  • No comorbidities.
  • Never used orthodontic appliances.
  • Preserved surrounding spaces.
  • Healthy permanent dentition with good hygiene.

Exclusion criteria

  • Patients will be excluded:
  • Who are taking drugs that affect bone metabolism and the inflammatory process (for example corticosteroids, bisphosphonates), who have used anti-inflammatory drugs or analgesics for less than 1 week since placing elastomeric separators.
  • Present general pathologies (craniofacial anomalies) and local ones (dental anomalies) that affect the result of the movement of the teeth,
  • Smokers, embarrassed, or breastfeeding women.
  • Allergic to paracetamol®
  • During the investigation, another different drug was used, which was made available by the investigators, and the patient was informed about this alteration.

Treatment and study plan

Photobiomodulation

Radiation

Application of photobiomodulation

Simulation of Photobiomodulation

Other

Simulation of photobiomodulation

Primary outcomes

  1. pain control after placement of elastomeric spacers - baseline

    Time frame: baseline

    Visual analogue scale

  2. pain control after placement of elastomeric spacers - 24 hours

    Time frame: 24 hours

    Visual analog scale measuing 0 to 10 were "0" is no pain and "10" is the worst pain in life

  3. pain control after placement of elastomeric spacers - 72 hours

    Time frame: 72 hours

    Visual analog scale measuing 0 to 10 were "0" is no pain and "10" is the worst pain in life

Secondary outcomes

  1. Number of analgesics taken baseline

    Time frame: baseline

    The analgesic used will only be paracetamol. It will be used only if there is pain.

  2. Number of analgesics taken 3 days

    Time frame: 3 days after procedure

    The analgesic used will only be paracetamol. It will be used only if there is pain.

  3. Local temperature baseline

    Time frame: baseline

    evaluated using a digital thermometer

  4. Local temperature 24 hours

    Time frame: 24 hours

    evaluated using a digital thermometer

  5. The quality of life related to oral health baseline

    Time frame: baseline

    will be evaluated using the OHIP-14 questionnaire

  6. The quality of life related to oral health -72 hours

    Time frame: 72 hours

    will be evaluated using the OHIP-14 questionnaire

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

Effect of Photobiomodulation on Pain Control After Placement of Elastomeric Spacers: a Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2023
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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