Clinical trial NCT05924191: Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars
Official title: Evaluation of the Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars: a Double-blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Molar, Third
Photobiomodulation
Keywords: photobiomodulation
corticosteroids
extraction
edema
pain
mouth opening
quality of life
randomized clinical trial
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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. To control these events, the prophylactic use of anti-inflammatory steroids has been widely recommended by some authors. However, there is no strong evidence on the real benefits of its use as opposed to its possible side effects. Photobiomodulation has proven to be a good alternative when applied in the postoperative period to control pain, edema and lockjaw. On the contrary, its application prior to a procedure of this type has not been sufficiently evaluated. 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. Healthy individuals (ASA I), who have an indication for extraction and are included in the study, will be randomly divided into two groups: Control Group: with the administration of prophylactic Corticosteroid (Dexamethasone 8 mg/ 1h before surgery), and the simulated application of Photobiomodulation, under the same protocol as the Study Group and Study Group: to which Photobiomodulation will be applied by means of intraoral Low Intensity Laser with wavelengths of 660nm and 808nm applied at 4 anatomical points (power of 0.1W, radiant exposure of 1,061 J/cm2 and energy of 3J per point and an application time of 30 seconds, totaling 12J of energy). Besides, the extraoral application will be carried out with a cluster device of combined LEDs with a total exposure area of 20cm2, which will be composed of 5 LEDs with a wavelength of 630nm (power of 0.25W per LED, a radiant exposure of 3 J /cm2 and energy of 12 J per LED spot, with an exposure time of 48 seconds) and 4 LEDs with a wavelength of 850 nm (power of 0.3W per LED, a radiant exposure of 2.4 J/cm2 and an energy of 12J per LED point, and an exposure time of 40 seconds). The Study Group will be administered a placebo tablet simulating Dexamethasone, also 1 h before the surgical procedure. 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) after the first 3 postoperative days, where Ketorolac 10 mg will be administered orally, in a regulated manner. 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.

Keywords: photobiomodulation, corticosteroids, extraction, edema, pain, lockjaw, quality of life, randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* 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.
* Good oral hygiene.
* That they agree to participate in the study, after reading and signing the Informed Consent for participation in clinical research.

Exclusion Criteria:

* 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
* During pregnancy or lactation,
* That they were using anti-inflammatories or analgesics,
* Allergic to any of the drugs used in the research (amoxicillin, ketorolac, acetaminophen, dexamethasone, chlorhexidine 2%, local anesthetics, sodium bisulfite, etc.)
* That during surgery they present any type of complication (bleeding, transoperative difficulties, etc.), because these cases are not included within the expected pattern behavior for this type of surgery (these cases will be reported),
* Surgical time greater than 90 minutes.

Primary outcomes:
measure: Postoperative Edema baseline
timeFrame: Edema wil be evaluated immediatly before the surgery (baseline)
measure: Postoperative Edema - 48 hours postoperative
timeFrame: Edema wil be evaluated at 2 postoperative days.
measure: Postoperative Edema - 7day postoperative
timeFrame: Edema wil be evaluated at 7 postoperative days.
Secondary outcomes:
measure: Postoperative Pain baseline
timeFrame: In this study, the VAS will be used immediately before surgery (Baseline)
measure: Postoperative Pain - 48 hours
timeFrame: In this study, the VAS will be used at 2 postoperative days
measure: Postoperative Pain - 7 days
timeFrame: In this study, the VAS will be used 7 days before surgery
measure: Postoperative use of analgesics - baseline
timeFrame: The amount of analgesics will be recorded in the baseline.
measure: Postoperative use of analgesics - 7th days
timeFrame: The amount of analgesics will be recorded after the third postoperative day until the 7th. post-operative day.
measure: Postoperative Trismus - baseline
timeFrame: In the present study, the previously calibrated evaluators will measure the mouth opening in each patient before the surgeries (baseline)
measure: Postoperative Trismus 48 hours
timeFrame: In the present study, the previously calibrated evaluators will measure the mouth opening in each patient at 2 postoperative days.
measure: Postoperative Trismus - 7 days
timeFrame: In the present study, the previously calibrated evaluators will measure the mouth opening in each patient after 7 postoperative days.
measure: Postoperative Local temperature baseline
timeFrame: baseline
measure: Postoperative Local temperature 48 hours
timeFrame: Thermographic photographs wil be taken 2 days after surgery.
measure: Postoperative Local temperature - 7 days
timeFrame: Thermographic photographs wil be taken 7 days after surgery.
measure: Postoperative Quality of life - baseline
timeFrame: Quality of life will be evaluated in the baseline
measure: Postoperative Quality of life - 48 hours
timeFrame: Quality of life will be evaluated two days after surgery,
measure: Postoperative Quality of life - 7 days
timeFrame: Quality of life will be evaluated seven days after surgery,
measure: Postoperative Dysphagia baseline
timeFrame: Dysphagia will be evaluated at baseline
measure: Postoperative Dysphagia 48 hours
timeFrame: Dysphagia will be evaluated at 2 days post-surgery
measure: Postoperative Dysphagia - 7 days
timeFrame: Dysphagia will be evaluated 7 days post-surgery
measure: Postoperative Hematoma/ecchymosis - baseline
timeFrame: Hematoma/ecchymosis will be evaluated at baseline
measure: Postoperative Hematoma/ecchymosis
timeFrame: Hematoma/ecchymosis will be evaluated 2 days after surgery,
measure: Postoperative Hematoma/ecchymosis - 7 days
timeFrame: Hematoma/ecchymosis will be evaluated 7 days after surgery,
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Kristianne Porta Santos Fernandes
state: SP
Study officials:
References: