Anna Carolina R.T. Horliana
São Paulo, 11030-480, Brazil
NCT Number: NCT05924204
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.
This study is active but is not currently recruiting participants.
13 year–30 year
All sexes
Interventional
Not applicable
São Paulo, 11030-480, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of photobiomodulation
Simulation of photobiomodulation
Time frame: baseline
Visual analogue scale
Time frame: 24 hours
Visual analog scale measuing 0 to 10 were "0" is no pain and "10" is the worst pain in life
Time frame: 72 hours
Visual analog scale measuing 0 to 10 were "0" is no pain and "10" is the worst pain in life
Time frame: baseline
The analgesic used will only be paracetamol. It will be used only if there is pain.
Time frame: 3 days after procedure
The analgesic used will only be paracetamol. It will be used only if there is pain.
Time frame: baseline
evaluated using a digital thermometer
Time frame: 24 hours
evaluated using a digital thermometer
Time frame: baseline
will be evaluated using the OHIP-14 questionnaire
Time frame: 72 hours
will be evaluated using the OHIP-14 questionnaire
University of Nove de Julho
Other
Effect of Photobiomodulation on Pain Control After Placement of Elastomeric Spacers: a Randomized Controlled Trial.
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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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