Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Nove de Julho
About this trial
The objective of this study will be to evaluate if photobiomodulation (FBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled and double-blind clinical study, 34 patients without comorbidities who need endodontic surgery in the upper jaw (15 to 25 teeth) will be recruited. They will be randomly divided into an experimental group (n = 17) photobiomodulation (808nm, 100 mW, and 4J/cm2 with 5 points per vestibular). Applications will be made in the immediate postoperative period and 24 hours after surgery. Control group (n = 17) a FBM simulation will be performed in the same way as in the experimental group. In this group, the required analgesia will be administered within the standard with ibuprofen. Both groups will perform the necessary conventional procedures considered the gold standard in the literature. Both the patient and the evaluator will be blinded to the intervention performed. The primary outcome variable of the study will be postoperative pain, which will be assessed using the visual analog scale at all postoperative control visits (baseline, 24 hours and 7 days). As for the secondary outcome variables, the amount of systemic medication received according to the patient's need (will be provided by the investigator).. Radiographic images will be obtained after 1 and 2 months for evaluation of the repair (dimensions of the lesion, radiopacity). These radiographs will be taken digitally with the positioners implemented. Edema, ecchymosis, and evaluation of soft tissues in the anterior portion of the intra and extra-oral maxilla will also be evaluated. In addition, a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The X-rays will be taken in the 1st and 3rd month respectively.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with not comorbidities,
Age from 18 to 70 years,
Both genders,
Healthy permanent teeth with good hygiene.
Disqualifiers
Who are taking drugs that affect bone metabolism and the inflammatory process (for example: corticosteroids, bisphosphonates),
Smokers, pregnant or lactating women,
Who used anti-inflammatory drugs in the last 3 months before surgery.
Who for any reason interrupted the evolution of the treatment for not attending joint appointments.
Trial design
Design model
Parallel
Treatments tested in this trial
Ibuprofen
DrugAll participants will undergo the same conventional surgical procedure. Patients will receive the FBM simulation and will be treated identically to the G2 group.
Photobiomodulation simulation
Other interventionThe person responsible for applying the FBM will simulate the radiation by placing the devices in the same places described for the FBM group, however, the equipment will remain turned off.
Photobiomodulation
Device. Patients will receive FBM and will be treated identically to the G2 group. The irradiated region will be on the lesion at 4 equidistant points on the vertex of a flat square 1 cm away.
Ibuprofen simulation
Other interventionPlacebo ibuprofen will be manipulated by pharmacy (Matias Gonzalez)
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: G1- Control groupActive comparator 2 interventions
Group B: G2- Intervention groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Pain in postoperative period - baseline
The primary outcome was Pain in the postoperative period, assessed using a 10 cm Visual Analogue Scale (VAS), where 0 represented "no pain" and 10 represented "worst pain imaginable." The main analysis focused on the change in pain intensity at 24 hours postoperatively compared to baseline (immediate postoperative period), as this time point is considered the most clinically relevant for evaluating the effectiveness of photobiomodulation in the management of acute postoperative pain.
Time frame
Baseline (Before the intervention)2
Pain in postoperative period - 24 hours after treatment
The primary outcome was Pain in the postoperative period, assessed using a 10 cm Visual Analogue Scale (VAS), where 0 represented "no pain" and 10 represented "worst pain imaginable." The main analysis focused on the change in pain intensity at 24 hours postoperatively compared to baseline (immediate postoperative period), as this time point is considered the most clinically relevant for evaluating the effectiveness of photobiomodulation in the management of acute postoperative pain.
Time frame
24 hours after treatmentSecondary outcomes
1
Pain in postoperative period - 7 days after treatment
Pain will also be assessed on the 7th day after surgery; however, this is defined as a secondary outcome, since other postoperative parameters-such as edema, ecchymosis, and soft tissue condition-will be evaluated at this time. Based on the literature, we do not expect significant pain at this later stage
Time frame
7th days after treatment2
Quantity of analgesics taken in the specific periods - baseline
The number of analgesics taken at the baseline will be recorded. Paracetamol will be the sole analgesic administered to the patients and recommended for use solely in cases of pain after surgery.
Time frame
Baseline (Before the intervention)3
Quantity of analgesics taken in the specific periods - 24 hours after treatment
The number of analgesics taken in the first 24 hours following surgery will be recorded. Paracetamol will be the sole analgesic administered to the patients and recommended for usage solely in cases of pain.
Time frame
24 hours after treatment4
Quantity of analgesics taken in the specific periods - 7 days after treatment
The number of analgesics taken in the seven days following surgery will be recorded. Paracetamol will be the sole analgesic administered to the patients and recommended for usage solely in cases of pain.
Time frame
7 days after treatmentSponsors and contacts
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Source ClinicalTrials.gov