Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Nove de Julho
About this trial
Third molar extraction is one of the most performed surgical procedures in Dentistry. A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain, edema, and lockjaw. Therefore, the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molars.The primary study variable will be postoperative edema measured in millimeters, 48 hours after surgery, and the secondary variables will be: pain, lockjaw, local temperature (measured with a thermographic camera), dysphagia, and the need to ingest nonsteroidal analgesics (Acetaminophen)These variables will be evaluated at the beginning of the study (baseline), at 2 and 7 days post-surgery. All adverse effects will be recorded. The data obtained will be represented by their means ± SD and the p value will be set at 0.05.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients who present retained lower third molars, according to the degree of surgical difficulty of the procedure and the anatomical position.The selected molars will be those classified according to classes II and III and/or B or C of Pell and Gregory Classification; in vertical or mesio-angular position, according to the Winter Classification or Class II with need for ostectomy or III, with need for ostectomy and odontosection of the Prant Scale, modified by Amarillas-Escobar et al.
That have an indication for the extraction of the lower third molars (due to recurrent infections, bad anatomical position, orthodontic indication) or a professional indication presented in writing and that are healthy (ASA I, with a negative medical history).
Male or female gender.
Age between 18 and 50 years.
Disqualifiers
Carriers of local alterations that contraindicate surgical intervention or complicate the postoperative period (example: acute phase pericoronitis in the last 30 days, ankylosis of the temporomandibular joint).
Smokers,
Presenting absence of upper and lower central incisors,
With a medical history of photosensitivity
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation
DeviceIntra-oral irradiations wll be performed with a low intensity Laser device at 4 anatomical points, with a wavelength of 660 nm. The extraoral FBM will be applied with 1 cluster (20cm2) with a wavelength of 630nm. Subsequently, the same region will be irradiated with the same cluster, using the 4 LEDs with a wavelength of 850 nm 1 hour before performing the surgery.
Placebo Corticosteroid
DrugParticipants will receive 1 hour before the surgery a placebo tablet, with the same physical and organoleptic characteristics, composed of corn starch, without harmful effects on health and simulating Dexamethasone (Celsius Laboratory, Montevideo, Uruguay).).
Simulation Photobiomodulation
DeviceThe irradiation simulations will be practiced in the same anatomical points described in the experimental group. This protocol will be carried out 1 hour before the surgical procedure (Baseline). The Laser device will be disconnected and its beep sound will be recorded and run on simulating the irradiation.
Corticosteroid
DrugThe patients will receive Dexamethasone 8 mg (Corodex, Laboratorio Celsius, Montevideo, Uruguay) PO 1 hour before surgery (Almeida et al 2019)
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Postoperative Edema baseline
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points
Time frame
Edema wil be evaluated immediatly before the surgery (baseline)2
Postoperative Edema - 48 hours postoperative
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.
Time frame
Edema wil be evaluated at 2 postoperative days.3
Postoperative Edema - 7day postoperative
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.
Time frame
Edema wil be evaluated at 7 postoperative days.Secondary outcomes
1
Postoperative Pain baseline
Pain sensitivity - The Visual Analogue Scale (VAS) is the most commonly used instrument for the assessment of postoperative pain in oral surgeries when FBM is used as post-surgical palliative therapy (Yüksek, Eroglu 2021, Momeni et al 2021, Amarillas -Escobar et al 2010, López-Ramírez et al 2011, Brignardello-Petersen et al 2012, Sierra et al 2013, Sierra et al 2015). A rule will be used, graduated in cm, 10 cm long. One of the extremes represents "0", which means "no pain" and the other represents "10" which indicates "unbearable pain". The intermediate graduation gives patients the possibility of rating the intensity of their painful experience, from 0 to 10. This rule will be the same for all study participants and the indications for its use and marking will be given to the patient, always by the same operator
Time frame
In this study, the VAS will be used immediately before surgery (Baseline)2
Postoperative Pain - 48 hours
Pain sensitivity - The Visual Analogue Scale (VAS) is the most commonly used instrument for the assessment of postoperative pain in oral surgeries when FBM is used as post-surgical palliative therapy (Yüksek, Eroglu 2021, Momeni et al 2021, Amarillas -Escobar et al 2010, López-Ramírez et al 2011, Brignardello-Petersen et al 2012, Sierra et al 2013, Sierra et al 2015). A rule will be used, graduated in cm, 10 cm long. One of the extremes represents "0", which means "no pain" and the other represents "10" which indicates "unbearable pain". The intermediate graduation gives patients the possibility of rating the intensity of their painful experience, from 0 to 10. This rule will be the same for all study participants and the indications for its use and marking will be given to the patient, always by the same operator
Time frame
In this study, the VAS will be used at 2 postoperative days3
Postoperative Pain - 7 days
Pain sensitivity - The Visual Analogue Scale (VAS) is the most commonly used instrument for the assessment of postoperative pain in oral surgeries when FBM is used as post-surgical palliative therapy (Yüksek, Eroglu 2021, Momeni et al 2021, Amarillas -Escobar et al 2010, López-Ramírez et al 2011, Brignardello-Petersen et al 2012, Sierra et al 2013, Sierra et al 2015). A rule will be used, graduated in cm, 10 cm long. One of the extremes represents "0", which means "no pain" and the other represents "10" which indicates "unbearable pain". The intermediate graduation gives patients the possibility of rating the intensity of their painful experience, from 0 to 10. This rule will be the same for all study participants and the indications for its use and marking will be given to the patient, always by the same operator
Time frame
In this study, the VAS will be used 7 days before surgery4
Postoperative use of analgesics - baseline
Amount of analgesics necessarily ingested, as a rescue: The amount of analgesic (Acetaminophen), a drug with a purely analgesic effect (Józwiak-Bebenista 2014) ingested by the patient (500 mg every 6 hours if the pain continues), will be recorded. At the beginning of the investigation, each patient will be given a form to record daily consumption, after the 3rd. post-operative day, and must be kept until the end of its use, at surgical discharge. At the end of the study, the amount of Acetaminophen tablets used will be evaluated as a secondary variable. The adherence of the participants to the study will be monitored through this means, asking the patients to present the form to verify its use.
Time frame
The amount of analgesics will be recorded in the baseline.Sponsors and contacts
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Source ClinicalTrials.gov